laboratory nformatics i Business solutionsBecoming Paperless with an Integrated Laboratory...

A collection of customer success stories

laboratory informatics Business solutions

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[ TABLE OF CONTENTS ]

emPoW er cHromAtoGrAPHY DAtA softWArecompliant-ready software for advanced data acquisition, processing, reporting, and distribution. Provides control of Waters AcQuitY uPlc,® uPc,2® HPlc, and lc/ms systems, as well as non-Waters HPlc, Gc, ce, and PDA systems.

A cro increases competitive Advantage by implementing empower chromatography Data software ..................................7

Becoming Paperless with an integrated laboratory informatics landscape ............................................................................9

improving laboratory efficiency and reducing compliance efforts With a networked chromatography Data system ........ 13

improving Quality control and stability testing efficiency with standardized chromatography operations ...................... 15

supporting innovation by implementing a lean Paperless lab ..............................................................................................17

increasing lab efficiency by chromatography Data system Harmonization ..........................................................................21

manufacturer reduces Vitamin Qc Analysis times by up to 90% ........................................................................................ 23

multi-Vendor instrument control minimizes training and Validation efforts with empower software ................................. 25

eliminating chromatography Data transfer to spreadsheets: reducing errors and improving Productivity with custom calculations using empower software ................................................................. 27

streamlining method Validation in Pharmaceutical Product Development with empower software method Validation manager ............................................................................................................ 29

[ TABLE OF CONTENTS ]

customer success is tHe true meAsure of ProDuct PerformAnce

Waters Laboratory Informatics Software comprises a powerful suite of solutions for instrument control, scientific data management, scientific search, network integration, and compliance management to streamline analytical laboratory operations.

our informatics solutions have helped leading pharmaceutical, environmental, food and beverage, and chemical materials organizations reduce costs, accelerate decision making, improve laboratory effectiveness, and get products to market faster.

[ TABLE OF CONTENTS ][ TABLE OF CONTENTS ]

nuGenesis PlAtformA comprehensive compliance-ready data management and workflow solution that uniquely combines data repository, electronic laboratory notebook, sample management, laboratories inventories, and e-record lifecycle management.

improving Data Accessibility and intellectual Property management with nuGenesis sDms .............................................. 33

employing a Bioanalytical Data management system to increase Workflow efficiency with nuGenesis sDms .................. 35

increasing efficiency in manufacturing Quality control with nuGenesis sDms ................................................................... 39

improving Data management and Accessibility Across multiple Geographies with nuGenesis sDms ..................................41

informatics technology Assists in 21 cfr 11 compliance with nuGenesis sDms ............................................................... 43

optimizing efficiency with electronic regulatory submissions with nuGenesis sDms ........................................................ 45

optimizing image Data Processing and storage for Drug Development with nuGenesis sDms ........................................... 47

regional Healthcare laboratory Automates QA/Qc Process Workflow with nuGenesis eln ............................................... 49

Automation of Doping control Applications with nuGenesis sDms and targetlynx ............................................................51

mAsslYnX softWAreAcquires, analyzes, and distributes Waters mass spectrometry information for comprehensive instrument control and data processing. Application managers automate manual data processing to optimize workflow.

compound Profiling: increasing the throughput of Physicochemical Profiling with Profilelynx Application manager for masslynx software ............................................................................................. 55

High-throughput food safety lab Automates QA Data interpretation and recordkeeping with nuGenesis sDms and masslynx software ............................................................................................. 57

AnAlYticAl WorKfloW mAnAGerProvides a single point of access for the complete handling of all an alytical laboratory tasks.

Analysis order turnaround times reduced by 25% with Analytical Workflow manager .....................................................61

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BACKGROUND

A&m stabtest is an independent private contract research organization (cro) that provides

analytical research and development services for the pharmaceutical industry in support of drug

development programs. the German-based company has headquarters in Bergheim/cologne and

a branch in mainz. the company works for nearly all major pharmaceutical organizations with

clients located primarily in Germany, Austria, switzerland, france, and the Benelux countries.

the company also supports small biotech startup companies with their services.

A&m stabtest specializes in analysis and stability testing of finished pharmaceutical

products and active pharmaceutical ingredients (APis) according to icH requirements;

hence, the test results and documentation need to demonstrate expected quality. t he

company also provides development and product release testing; bioanalytical services;

and unknowns identification. the tested samples range from small molecule drugs

to biopharmaceutical therapies including proteins, peptides and antibodies. All activities

and analyses adhere to GmP/GlP regulations and to demonstrate compliance, the company

is routinely audited by customers and regulatory agencies. A&m stabtest operates in a

cost and time sensitive industry, consequently they continuously invest into efficiency

increasing strategies like employee training and adopting the latest technologies.

CHALLENGE

the laboratories at both sites employ more than one hundred users and operate approximately

50 HPlc instruments manufactured by shimadzu. Additional chromatographic equipment

includes six gas chromatograph instruments from Agilent and two capillary electrophoresis

instruments from Beckman and Agilent.

the HPlc instruments had been running under

the shimadzu class-VP software, which was

used as a hybrid system. only data recording

was performed with the system. chromatograms

were printed on paper and integrated

manually. in order to perform calculations,

data were transferred manually into validated

excel sheets. the different manual activities

required extensive double checks for errors

and corrections when necessary.

Business Benefits

As a result of the Empower

Chromatography Software

implementation, A&M

Stabtest’s scientific operations

have realized a variety of high-

value benefits including:

■■ Efficiency gains, such as a

time savings of 20% for the

result evaluation of a project.

■■ Enhanced response times

during regulatory and

customer audits given the

ease and speed for which

information can be accessed.

■■ Reducing the waste and

variability associated

with the chromatographic

workflow.

■■ Improved laboratory

productivity.

■■ Lower project costs.

■■ Increased competitiveness.

A CRO Increases Competitive Advantage by Implementing Empower Chromatography Data SoftwareClient: A&m stabtest Technology: empower™ chromatography Data software (cDs)

Waters Corporation 34 Maple Street Milford, MA 01757 U.S.A. T: 1 508 478 2000 F: 1 508 872 1990 www.waters.com

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Waters is a registered tradermark of Waters corporation. empower and t he science of What’s Possible are trademarks of Waters corporation. All other trademarks are the property of their respective owners.

©2012 Waters corporation. Produced in the u.s.A.July 2012 720004413en iH-PDf

System deployment

today empower is implemented in a citrix environment with

a server at each of the two sites to provide greater system

performance – analysts can access either empower server as

needed to share information. Advantages of operating under a

citrix environment include easy deployment of empower clients

on Pc hardware of differing specifications and streamlined

software validation, since only the empower and citrix servers

require validation.

empower software controls all chromatographic instruments

at both sites including data collection, chromatographic peak

integration, calculations and evaluations, and results review

and approval.

A&m stabtest opted for the integrated system suitability testing

option that allows for direct integration of their results into

reports – manual interaction is no longer required for these steps.

raw data, reports, and audit trails can easily be accessed within

empower, which is very convenient during routine audits.

Waters assisted A&m stabtest with the system Validation by

performing the installation and operation Qualification (iQ/oQ).

Performance Qualification was done by A&m stabtest’s staff.

concurrent with the validation efforts, all end users and power

users were trained by Waters in a test environment to ensure that

they could take full advantage of the empower production system.

With the validated production system in place and system training

for staff completed, A&m stabtest was able to switch from their

legacy system to the new cDs literally overnight.

Due to the competitiveness of the industry, A&m stabtest sought

to minimize waste and variability in the laboratory operations

by reducing time-consuming and error prone manual steps in the

chromatographic testing process.

THE SOLUTION

Platform selection

the decision was made to introduce a modern, state-of-the-art

chromatographic Data system (cDs). the user’s requirements

specification (urs) document developed by the company identified

required functionality, such as Part 11 technical controls, automated

calculations, data management, and multi-vendor instrument

support. As a result of the urs, two cDs solutions were considered,

Waters® empower software and Dionex/thermo chromeleon. the

company chose empower because it satisfied their functionality

requirements and provided an intuitive/professional user interface,

as well as a broad range of multi-vendor instrument drivers

(including those for shimadzu). interfaces were built through

partnerships with the instrument manufacturers to ensure reliability

and future upgrade paths. empower’s market leading position,

reputation for compliance-ready features, and continuous product

improvement solidified the decision.

Regulatory compliance

Because A&m stabtest must comply with regulatory safeguards

and demonstrate this to both customers and government agencies,

empower software functionalities that help facilitate regulatory

compliance are of tremendous value to the company. the data

traceability provided by empower’s audit trails allows staff

to easily locate information during routine audits. Because

speed of retrieval is so critical, the ability to separate audit trail

information by project, method, etc., was considered a key feature.

BACKGROUND

the pharmaceutical division of a global healthcare organization has a comprehensive distribution network

along with major production facilities in europe, north America, latin America, and Asia-Pacific.

the Qc laboratories at one of the company’s large Active Pharmaceutical ingredients (APi) production

sites in europe utilize more than 100 chromatographic instruments manufactured by multiple vendors.

most of the chromatographic operation was controlled by empower chromatography Data software (cDs),

but a second cDs solution was used for some of the instruments. their sample workflow was managed

by Waters® legacy Q-Dis/Qm,™ a classical laboratory information management system (lims), and the

weighing process was supported by Balance View, a third independent system.

CHALLENGE

Although the existing system architecture managed daily chromatographic activities adequately,

integration of these platforms was lacking. As a result, laboratory operations were still dominated by

paper processes. utilizing paper for information exchange was identified as a significant source of waste

and variability, e.g., handling paper documentation was very time-consuming and the related manual

steps were prone to errors. Additionally, archiving the analytical raw data on paper added significant

cost overhead to their laboratory services. for example, a chromatographic sequence that consisted

of 20 samples would equate to the storage of a 50 to 60 page report.

Becoming Paperless with an Integrated Laboratory Informatics LandscapeClient: Pharmaceutical Division of a Global Healthcare organization Technology: empower™ chromatography Data software and nuGenesis® sDms software

Costs for the entire

solution were

recouped in less

than 12 months and

analysis processes

are more than 50%

faster than before.

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since their laboratory operations adhere to GxP regulations,

customer and regulatory agency audits are a routine part

of business. However, retrieving results and data stored

on paper was a very laborious process. for example, the

Pharmaceutical inspection convention and Pharmaceutical

inspection co-operation scheme (Pic/s) or fDA regulatory

audits, required significant preparation time for structuring paper

data, photocopying the relevant documents and cross-checking.

Additionally, customers throughout the company’s distribution

channels would occasionally request information during root

cause investigations, which would necessitate expending

significant effort to locate and retrieve paper records.

to establish a more automated data flow along with enhanced

data management integrity, the client sought to achieve a fully

integrated laboratory informatics landscape.

T HE SOLUT ION Standardizing on a single CDS

the first step towards comprehensive integration was to standardize

on a cDs - empower software was chosen for this purpose.

the advantages of empower identified by the client include:

■■ continuous product improvements

■■ Ability to run under technologies like citrix

■■ comprehensive Application Programming interface (APi)

for information exchange between external systems

■■ full scalability so it can be extended as needed.

Previous experience with empower software in the client’s

corporate headquarters laboratories further solidified its

selection as the single cDs solution. empower now controls

all chromatographic instruments (over 100) and supports

80 to 90 users at the production site.

A single data repository

Although empower provides comprehensive management of

chromatographic data, the client desired an additional solution

capable of managing information from a wide variety of analytical

techniques. Waters nuGenesis scientific Data management system

(sDms) was introduced into the laboratory to meet these needs.

nuGenesis sDms was implemented to capture all printed reports

for both chromatographic and non-chromatographic results so

that all reports would reside in a single compliance-ready and

searchable data repository. the benefits of a single repository for

reports include a common place for review and approval; easier

retrieval of during an audit; and the ability to summarize and send

reports to other systems such as lims by making using of the APi.

A paperless information workflow

After the adoption of a single cDs for chromatography workflows

and an sDms for all testing reports, it was possible to integrate

the laboratory information workflow together electronically. Work

lists are created within the lims and transferred into an internally

developed database. the weighing system transfers the weights

from the balances into the same database where the weights are

included into the work lists. the relevant data is consolidated

into the work lists and then transferred into the sample sets of

empower software. After performing the tests and calculations

within empower, the reports are generated by empower and

printed into nuGenesis sDms where they can easily be accessed.

the electronic signature workflow includes two checks by different

individuals and is fully supported by nuGenesis sDms. the results

are displayed again before eventually being transferred to the

lims. this entire process, which includes an audit trail, is done

without paper or manual steps, thereby reducing time and errors.

Hence, nuGenesis sDms works as a central data repository where

all chromatographic and related data are securely stored and

can easily be retrieved and accessed. result reports captured

by nuGenesis sDms also appear exactly as they had in paper,

facilitating a high level of acceptance.

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Electronic data retrieval

When customers request information about certain batches they

can now retrieve it themselves within the system based on the

iD number. Granting customers access to data within nuGenesis

sDms can be done confidently – access levels allow them to see

only what they have permission to use. An additional benefit of

electronic searching within the sDms data repository is that the

time required to prepare documentation for audits is almost zero.

Data can be retrieved on short notice independently of record age.

Data can be accessed by relevant search terms (i.e. metadata),

and printed out for the auditor. in total, this takes only ten minutes

(instead of days), which demonstrates to auditors that data

management is effective and compliant.

BUSINESS BENEFIT S

Adoption of empower and nuGenesis sDms as the standard cDs

and sDms solutions (and integration with the lims and sample

weighing system) have allowed the company to transition to

a greater than 90% paperless process in the chromatographic

portion of laboratory operations for APi batch release. this has

led to a number of significant business benefits, including:

■■ increased compliance

■■ reduced errors

■■ increased data security

■■ improved data sharing

■■ streamlined workflow

■■ increased efficiency

■■ significant cost savings (time, storage space, paper)

measurements performed after project completion have

demonstrated that costs for the entire solution were recouped in

less than 12 months and analysis processes are more than 50%

faster than before. the new paperless lab is an important step

towards meeting the company’s first time-right culture.

Waters and nuGenesis are registered trademarks of Waters corporation. empower, Q-Dis/Qm, and t he science of What’s Possible are trademarks of Waters corporation. All other trademarks are the property of their respective owners.

©2012 Waters corporation. Produced in the u.s.A.June 2012 720004399en lB-PDf

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BACKGROUND

erregierre is a leading international manufacturer of active ingredients for the pharmaceutical

and generics industries. the company has two cGmP manufacturing sites in italy and

includes a research and Development organization that enables erregierre to provide

fast-track process development and a high level of service in custom synthesis. t he

products include cardiovascular, central nervous system disease, antifungal, anti-

inflammatory, gastrointestinal, anti-allergic, and expectorant areas. the broad area

of products demand about thirty different synthesis reaction categories, which require

high flexibility in the production process, as well as in the accompanying quality control

testing and review. erregierre serves international markets requiring compliance with

fDA and emeA regulations; hence, the business and laboratories must strictly adhere

to GxP regulations.

CHALLENGE

the main site in san Paolo d’Argon includes a Quality control and an Analytical Development

laboratory with 20 HPlc and uPlc® instruments and nine users. the site in sovere has a

Quality control lab where three people work with five HPlc instruments. All of the liquid

chromatographic instruments were manufactured by Waters and were controlled by separate

empower personal workstations.

the laboratory challenge centered on supporting quality testing for a large variety of

products with differing production timetables. chromatography testing on different

projects often required the development and utilization of different separation methods;

however, reliance upon un-networked personal workstation chromatographic systems

meant that it was necessary to manually

maintain projects and methods for each of

the 25 individual instruments. Hence, the

ideal solution to avoid the redundant manual

work was to convert the isolated empower

personal workstations into a single networked

chromatographic Data system (cDs) so

that developed methods were available on

appropriate HPlc and uPlc instruments.

Improving Laboratory Efficiency and Reducing Compliance Efforts With a Networked Chromatography Data SystemClient: erregierreTechnology: empower™ chromatography Data software (cDs)

Business Benefits

With the migration to the

Waters Empower CDS network

and by using the option of self-

directed software qualification,

Erregierre has been able to

increase their productivity,

improve regulatory compliance

adherence, and reduce costs.

Key benefits include:

■■ Increased efficiency in

method creation and

maintenance.

■■ Cost savings of 50,000

Euros per year.

■■ Reduced qualification and

validation efforts by 20%.

■■ Increased regulatory

compliance adherence.

■■ Increased data security.

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Waters and uPlc are registered trademarks of Waters corporation. empower and t he science of What’s Possible are trademarks of Waters corporation. All other trademarks are the property of their respective owners.

©2012 Waters corporation. Produced in the u.s.A.July 2012 720004414en iH-PDf

compliance efforts have been significantly reduced because now

only one network cDs solution requires validation versus the

25 separate personal workstations that were required prior to

the migration. An additional observation has been made during

regulatory audits.

the backup of the chromatographic data is now done automatically

from the individual client systems to the empower server. this

automation of the process not only saves time but has also

increased data security. erregierre’s qualification and validation

efforts have been reduced by 20%.

After the implementation of the empower cDs network, erregierre

took an additional step to improve the lab efficiency. Waters®

Global services provided maintenance and qualification of the

chromatographic software and system. After deployment of

the empower cDs network, the staff received additional training

by Waters on performing periodical qualifications themselves

by using the Automated Qualification tool (AQt). AQt is an

electronic tool for empower that fully automates and simplifies the

qualification process for Waters chromatography and electronic data

management systems. With this training erregierre became self-

sufficient in their cDs qualification activities. they now perform the

tests four times a year, whereas previously they had only performed

qualification once per year. the time effort has remained the same,

but now they have the opportunity to update and cover more aspects

of the system. today Waters is still performing the maintenance of

the system, but by using the self-directed AQt, erregierre is now

able to qualify more systems in a more complete way, which

has led to time savings and increased confidence at the same

time. Additionally, they were able to achieve a cost savings of

50,000 euros per year.

Backing up chromatographic data represented an additional

challenge because utilizing isolated personal workstations

meant that the backups had to be done manually by saving data

on cDs or the intranet. this process was tedious and there was no

guarantee that all data were securely stored.

Working as a contract manufacturing organization (cmo) in

an international market, erregierre is subject to audits and

inspections by regulatory agencies and customers on a regular

basis. customer audits require that the laboratories spend

approximately one week per month focused on inspection and

related activities, such as preparation. While this is a necessary

part of doing business for a cmo, inspection activities are

time-consuming and considered non-value added with regards

to laboratory productivity.

THE SOLUTION

the decision was made to migrate from empower personal

workstations to an empower cDs network because the functionalities

of the network solution are suitable for erregierre’s chromatographic

quality testing application and regulatory compliance requirements.

they were also satisfied with the Waters’ unique range of service

offerings, including qualification for HPlc instrumentation.

tremendous efficiency gains have been achieved for the

chromatographic method development by using empower as a single

cDs network solution. once a method is created it can now be used

by all of the compatible chromatographic systems in service, which

has simplified their activities and increased productivity.

BACKGROUND

uK-based napp Pharmaceutical Group is part of a worldwide association of independent

companies. the company manufactures and markets innovative products in the areas

of oncology, respiratory, and pain management – with analgesia being their largest

therapeutic area.

one of napp Pharmaceuticals core values is innovation, which defines behaviors and

decisions within the organization and therefore drives strategies in the laboratory and

informatics environment.

At the site in cambridge, the Quality control (Qc) and stability laboratories perform the

required testing of raw materials, intermediates, and final release. A total of 22 people

are tasked with release and shelf life stability testing. the two laboratories are equipped

with 54 chromatographic instruments from multiple vendors where 34 of the 54 systems

consist of dissolution baths. the chromatographic data system (cDs) used in the two

labs is considered vital for achieving release of the products to market – and therefore

a key element in ensuring success of the entire organization.

CHALLENGE

the difficulties in managing and efficiently using different chromatography data

systems for chromatography and dissolution represented the largest challenge for

the laboratories. further adding to the complexity of operating separate cDs solutions,

the laboratory’s on-going data generation started to exceed the limits of the existing

file-based system data management process.

Besides the data management challenges, the use of excel for calculations and reporting

was an additional source of waste and variability in laboratory workflows. for example,

manual steps in documentation workflows provided the opportunity for errors due to

incorrect data transcriptions. furthermore, managers sometimes interrupted analysts

during testing to request access to reports.

in recent years, napp Pharmaceuticals’ success in the marketplace has translated

into greater product demand, which in turn led to the need for more sample testing

and reduced result turnaround times. Any delays in testing translated into delays

in product releases thus directly impacting revenue. since chromatographic testing

was recognized as vital for the product release process, management determined

Improving Quality Control and Stability Testing Efficiency with Standardized Chromatography OperationsClient: napp Pharmaceutical GroupTechnology: empower chromatography Data software (cDs)

Empower Software

provides a single

compliant-ready CDS

solution to improve

data management,

boost laboratory

productivity, and

reduce compliance risk.

15


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Waters is a registered trademark of Waters corporation. empower and t he science of What’s Possible are trademarks of Waters corporation. All other trademarks are the property of their respective owners.

©2012 Waters corporation. Produced in the u.s.A.April 2012 720004312en ll-PDf

that a single compliant-ready cDs solution was required to

improve data management, boost laboratory productivity, and

reduce compliance risk.

in order to deliver a single compliant-ready cDs solution for the

laboratory operations of napp Pharmaceuticals, the it department

developed a plan to implement a commercial off-the-shelf

software (cots) package. the ideal solution would standardize

chromatography operations on a single comprehensive cDs

solution that included integrated data capture, analysis (including

automated calculations), and reporting.

for a forward-looking company such as napp Pharmaceuticals, the

new cDs system should not only satisfy the needs of today, but

also serve as a platform for the needs of future business growth.

T HE SOLUT ION

A dedicated team of four analysts was assigned to the cDs

implementation project. During the six months analysis phase,

the team identified data security and integrity as key aspects

of the project. Armed with vendor selection criteria, the team

chose Waters® empower™ chromatography software as their new

cDs standard. empower was identified as a complete solution for

data capture, data analysis (with automated calculations), and

flexible reporting in one platform. As future workflow needs

arise, empower offers a large variety of add-on options such as

Data Guard for database replication and enterprise Data manager

(eDm) for archiving and restoring empower projects.

With the comprehensive reporting capabilities of empower, the

team was able to replace other reporting tools, including excel.

managers now have better access to critical reports by logging

onto empower from their own computers without the need to

stop an analyst during a testing procedure. making use of Waters’

“train-the-trainer” concept, the project team has designed custom

training for their colleagues to fit the workflows that analysts

perform routinely.

An additional advantage of empower is its advanced technology

and the fact that it is based on an oracle database. it is considered

a complete but continuously evolving solution and therefore

a sound investment for the future. the selection process was

weighted heavily on the capabilities of the product, but the team

also valued the culture of innovation prevalent at Waters – one

which aligned well with napp Pharmaceuticals’ own culture.

BUSINESS BENEFIT S

standardizing on empower software has enabled napp

Pharmaceuticals Qc and stability laboratories to increase sample

throughput for product release. At the same time, it provides

a foundation for future chromatographic data handling needs,

enabling innovation – one of the core values of this organization.

Benefits include:

■■ easier sharing of data between the labs

■■ improved communication

■■ removal of transcription errors

■■ easier access to information

■■ reduced errors because of a smoother

and undisturbed workflow

■■ reduced bottlenecks in the lab workflow

■■ increased sample throughput without

compromising on release times

■■ flexibility in staff allocation

■■ reduced training costs

Chiesi wanted to speed up

and automate activities,

such as processing,

transcription, and cross-

checking of data, in order

to provide a more rapid and

reliable information system

that allows innovation and

interpretation of data

to take priority.

Every aspect of the laboratory

is designed to support science

and innovation. Chiesi’s Technology Research Laboratory, Chippenham, UK

BACKGROUND

chiesi farmaceutici is a privately owned international research and strategic innovation

focused company in the Pharmaceutical sector that develops and markets products in the

respiratory, cardiovascular and musculoskeletal therapeutic areas.

Part of corporate r&D, chiesi ltd. is a technology research laboratory in chippenham,

uK that became fully functional in 2009. chiesi ltd. has initiated cutting-edge research

in the field of inhalation delivery, with a special focus on pressurized systems. the aim

is to leverage and broaden chiesi’s technology capabilities and to find innovative ways

to deliver drugs to the lungs. in order to remain at the forefront of inhalation delivery

technology, chiesi is constantly examining new and existing technologies with a view

of enhancing the performance of current and future pipelines.

CHALLENGE chiesi’s technology research laboratory was created de novo with a long-term vision

of enabling innovation, while taking full control of all data without the need for role

segregation and specialist input. the entire laboratory staff of 12 people possess

flexible skill sets that allow them to run all laboratory equipment. Hence, every aspect

of the laboratory is designed to support science and innovation and minimize any

non-value added activities.

Supporting Innovation by Implementing a Lean Paperless LabClient: chiesi ltd.Technologies: nuGenesis® sDms, nuGenesis eln, empower™ 3 cDs, AcQuitY uPlc®

17

the laboratory was designed around the concept of a paperless

system for data capture, retrieval, and archive. An electronic

solution was sought to provide an alternative to paper-based

processes and disparate databases, which many of chiesi’s users

had experienced at previous companies. their aim was to speed

up and automate activities, such as processing, transcription

and cross-checking of data, in order to provide a more rapid

and reliable information system that allowed innovation and

interpretation of data to take priority.

Based on user requirements, data retrieval and collaboration were

two compulsory key functionalities. Hence, from a technology

perspective, they desired a solution that utilized a relational

database with a centralized server in order to facilitate easily

storage and location of data.

Another aspect was the compatibility of the proposed software

with their instrument hardware. the research laboratory

simultaneously acquired two AQuitY uPlc systems from Waters,

and several analytical balances from mettler toleDo, and had

recently added sartorius. Hence, these analytical instruments

needed to interface with their new software solution.

T HE SOLUT ION

Besides fulfilling the technical requirements, chiesi’s purchasing

decisions were driven by the capability of the software and

instrumentation solutions to streamline and simplify their

laboratory – based processes. the demonstration phase of

the instrument and software solution confirmed this and built

confidence within the team.

in order to achieve a paperless lab and to eliminate all non-value

added manual and paper based steps in the laboratory, they

selected the complete laboratory informatics solution from

Waters, that included empower cDs (chromatographic Data

software), nuGenesis sDms (scientific Data management system),

and nuGenesis eln (electronic laboratory notebook).

two AcQuitY uPlc systems with AcQuitY® sQD (single

quadrupole ms detection) running under empower were

implemented. each of the systems is equipped with sample

organizer, Binary solvent manager, sample manager, column

manager, PDA Detector and sQD. on one of the systems,

a coronaultra rs for charged aerosol detection was utilized, that

is also controlled by empower. in addition to the comprehensive

multi-vendor instrument control provided by empower, other key

functionalities of the networked empower software are the custom

fields and custom calculations that allow chiesi ltd to eliminate

isolated spreadsheets for any cDs related calculations.

for laboratory data management, nuGenesis sDms is interfaced

with all instruments in the laboratory, including uPlc®, balances

etc. Although empower is capable of managing chromatography

data, it was decided that all laboratory data should reside in a

single data repository. Hence, data and reports from empower

as well as all results generated by any other instrument are

automatically captured into nuGenesis sDms. Additionally,

all scientific documentation created internally or by external

collaborators is securely stored in nuGenesis sDms. this includes

reports and even scanned drawings. the automatic metadata

extraction capability enables the easy retrieval of any information

for collaboration.

the creation of electronic documents plays a major role in the

paperless environment. the potentially time-consuming process

of searching for data and manually transcribing it has been

replaced by automatic import of information from the nuGenesis

sDms repository into nuGenesis eln reports.

even though the chippenham technology research centre does

not work under GxP regulations, reviews/approvals and double

signatures are an integral part of their data system – the ability

to verify continuous processes, concept development, and project

progression is essential for intellectual property protection. the

signature process is fully integrated into the electronic workflow

to demonstrate the integrity of the data.

every member of the staff was trained by Waters: this was

identified as the most efficient method to cross-train the entire

team. Hence, with everyone equally trained on all equipment

and software, workflow bottlenecks were eliminated. shortly

following training, the staff confidently designed custom fields in

the empower cDs and templates for documentation in nuGenesis

eln – as a result, the team was able to utilize the solutions within

a short timescale.

18


BUSINESS BENEFIT S

the main goal of implementing a paperless lab by utilizing

Waters solutions was to prioritize innovation activities

at chiesi ltd. Key benefits include:

■■ With uPlc and empower, an example run time was reduced

from ten minutes to one minute while solvent consumption

was reduced approximately twenty-fold.

■■ By using uPlc, the lab required fewer instruments compared

to traditional HPlc – this translates to reductions in individual

system suitability checks, maintenance, waste, and occupied

lab space.

■■ use of empower software not only provides chiesi ltd with

increased efficiency and data integrity by reducing manual

calculations and transcription; but also enables rapid

identification of unexpected results by setting definable

thresholds within empower.

■■ creation of documents for experiments had previously been

a paper-based and manual process. entering information

electronically into nuGenesis eln templates and importing

data from the nuGenesis sDms database greatly reduced the

time spent on this activity.

■■ review and signature activities are performed easily and

quickly within the nuGenesis system by research peers. Due

to the automatic transfer of data, cross-checking has been

reduced to a minimum, freeing up time for scientific tasks

rather than non-scientific, time-consuming activities.

■■ Proof of scientific integrity as well as intellectual Property

protection is possible with nuGenesis eln.

■■ Basic method development can now be completed in

a few hours, entire feasibility studies in a markedly shorter

length of time.

■■ elimination of superfluous documentation tasks has

contributed to very positive employee morale, keeping

the turnover minimal and allowing the team to remain

agile by keeping the staff number low.

Waters, AcQuitY uPlc, uPlc, AcQuitY, and nuGenesis are registered trademarks of Waters corporation. empower and the science of What’s Possible are trademarks of Waters corporation. All other trademarks are the property of their respective owners.

©2012 Waters corporation. Produced in the u.s.A.september 2012 720004448en Ao-PDf

19

The harmonization of the

CDS application installations

and introduction of Empower

has significantly increased

overall operational efficiency.

BACKGROUND

the client is engaged in the research, development, and production of generic human

medicines and in r&D of biotechnology-based medicines. With a vertical integration of

business units, their activities span from chemical development and production of active

substances to the pharmaceutical development, manufacturing, and packaging of finished

dosage forms. Products cover a large number of therapeutic areas that require complex

syntheses and sophisticated dosage forms. the company manufactures and sells products

in europe, as well as in the united states, south America, Australia, and other parts of the

world; hence, they must comply with regulatory requirements for the respective countries

where it sells products as defined by regulatory agencies such as the fDA, emeA, and tGA.

CHALLENGE

the analytical r&D, as well as production-related laboratories in the u.s. and europe

consisted of a diverse chromatography software landscape. most of the lc and Gc

instruments utilized specific workstation software from several different vendors. this

required a high training effort in order to ensure that individuals made optimal use of the

different systems. Due to number of software packages, keeping the different software

solutions current and validated was an additional challenge. finally, data management,

such as exchanging chromatographic information was very cumbersome since data was

stored on different drives, DVDs, and cDs. Additional information was contained on paper,

in microsoft excel, Word, Access, etc. furthermore Analytical services was often perceived

within manufacturing as the bottleneck during the batch release.

T HE SOLUT ION

in 2007, the client’s Analytical groups began investigating ways of increasing the

efficiency of u.s. and european laboratory operations in order to ‘do more with the same

people’ and ultimately reduce bottlenecks during batch releases. this strategy centered on

automating processes by introducing a laboratory information management system (lims)

and by harmonizing the chromatographic Data systems (cDs).

in addition, they required that the local cDs networks running at the different sites also

interface with the lims.

Increasing Lab Efficiency by Chromatography Data System HarmonizationThe client: A Generic Pharmaceutical company Technology: empower software

21


Waters and uPlc are registered trademarks of Waters corporation. empower and t he science of What’s Possible are trademarks of Waters corporation. All other trademarks are the property of their respective owners.

©2011 Waters corporation. Produced in the u.s.A.December 2011 720004172en Ao-PDf

the client selected Waters® empower™ chromatography software

for the cDs, since it was viewed as the industry standard that

undergoes continuous improvements of both standard and

add-on capabilities, such as third-party instrument control,

method validation, and method development. the software’s GmP

compliance technical controls and ability to control a wide variety

of uPlc®, HPlc, and Gc instruments from Waters, Agilent, and

shimadzu also weighed heavily in the decision. Also of critical

importance, the application programming interface (APi) allowed

empower to interface with the labWare lims.

An empower client server installation was introduced as

the company’s standard cDs in the Analytical research,

Development, and Quality control laboratories and was deployed

as independent networks for each site. All implementations

were deployed to satisfy regulatory requirements in a validated

environment for development and Qc. functionalities with

the largest impact from an efficiency standpoint included the

integrated e-signature process and the dissolution option, which

are considered necessities for a laboratory operating in a Generic

Pharmaceutical company.

the implementations at all sites have exactly the same

configuration for the regulated GxP laboratories, therefore the

documentation and validation overhead is streamlined. urs, iQ,

oQ, and PQ are the same at all regulated sites, which significantly

reduces the overall validation time and effort. Also, the empower

method Validation manager (mVm) software, which was

deployed in r&D, provides additional savings in time and

validation effort. Additional benefits of the empower software

implementation include the ability for the QA department to

modify standard operating Procedures (soPs), so that paper

reports are printed only at the very end of a completed testing

procedure versus throughout testing, as had been the case

previously, to increase analyst ease-of-use and align with

business sustainability practices.

BUSINESS BENEFIT S

the harmonization of the cDs application installations and

introduction of empower software has significantly increased

overall operational efficiency. Despite a heterogeneous mix of

projects in the different laboratories, their initial goal of doing

“more with the same people” was realized and the Analytical

departments experience much less pressure from their production

focused customers.

Benefits include:

■■ reduced data transfer and switching of applications

■■ reduced training and maintenance efforts

■■ reduced validation efforts

■■ easy exchange and availability of all chromatography-related

data and information within and between the different sites

■■ saving of paper and storage space

■■ compliant-ready software

■■ A reduction of bottlenecks during batch release

22

BACKGROUND

Dsm is a global science-based organization that is active in health, nutrition,

and materials. the company, which is comprised of 11 different business units,

delivers innovative solutions that improve performance in a broad range of global

markets. Dsm’s nutritional Products business is the world’s premier nutritional

ingredient manufacturer and supplier to producers of foods, beverages, and dietary

supplements. its product portfolio includes formulations for fat and water-soluble

vitamins, carotenoids for coloration, and novel nutraceuticals.

the nutritional Products business operates a manufacturing site in Belvidere,

new Jersey. the facility produces dry vitamin and mineral premixes, along

with liquid vitamin blends that are used in a variety of food and dietary supplement

products. Among other duties, the site’s Quality control laboratory is responsible

for verifying the composition of finished products and generating coAs (certificates

of analysis) for customers prior to shipment. Although the laboratory utilizes

a variety of analytical techniques for sample analyses, it relies principally on

liquid chromatography.

CHALLENGE

Dsm operates within a highly competitive industry, where it is critical to deliver

high quality products rapidly and cost effectively. Given the enormous production

volume at the new Jersey site, the Quality control laboratory must process

thousands of multi-analyte samples annually to confirm that final product is within

specifications. once a customer order is placed, analyses and corresponding coAs

must be completed as quickly as possible. Historically, laboratory workflow

had involved running an analysis method for a single vitamin on one dedicated

HPlc system – a process that was less than optimal.

in an effort to accelerate sample analysis turnaround time, reduce the cost of

analyses, and increase overall efficiency, the laboratory sought to enhance its

liquid chromatography-based capabilities. of critical importance to the Quality

control group was that any technology implementation be in alignment with

Dsm’s Quality vision.

Manufacturer Reduces Vitamin QC Analysis Times by Up to 90% Client: Dsm nutritional ProductsTechnology: AcQuitY uPlc H-class system and empower chromatography software

COAs can be generated

more rapidly ensuring

customers have the product

information they need as

quickly as possible.

23


Waters, AcQuitY uPlc, and uPlc are registered trademarks of Waters corporation. empower and t he science of What’s Possible are trademarks of Waters corporation. All other trademarks are the property of their respective owners.

©2011 Waters corporation. Printed in the u.s.A.July 2011 720003916en ll-AP

T HE SOLUTION

to meet their technological challenges and sustainability

objectives, the Quality control group purchased three of

Waters® AcQuitY uPlc® H-class systems with Photodiode

Array (PDA) Detectors and empower™ 2 chromatography

software. the AcQuitY uPlc H-class system provides the

flexibility of a quaternary-based HPlc with the performance

advantages of uPlc.® H-class enables users to continue running

existing HPlc methods or transition to uPlc separations using

integrated system tools and column kits that simplify migration.

since the implementation, the Qc group has transferred finished

product water and fat soluble vitamin assays from HPlc to the

uPlc H-class systems. All data acquisition and processing are

performed with empower software. this includes creation of a

standard report format to facilitate internal review by Qc analysts

and the use of empower’s custom calculations functionality to

generate customer-specific coA results.

“ The ‘Quality for Life’ vision at DSM Nutritional Products focuses on developing products and partnerships where the essential values of Quality, Reliability, Traceability, and Sustainability are critical. Waters UPLC Technology and Support services align with our values, and give us the confidence that we will continue to provide the world ‘Bright Science. Brighter Living,’ and remain the leader in providing nutritional solutions. I have worked with Waters Corporation for decades and found that their personnel and ‘green’ technology consistently support these values and help protect

our ‘Quality for Life’ promise to the world.”

TIM WELLS, Director of Quality, North America

BUSINESS BENEFIT S

By replacing traditional HPlc with AcQuitY uPlc H-class

systems, the Quality control laboratory at Dsm’s new Jersey

site has realized several benefits in key areas, including:

■■ laboratory productivity ■■ test procedures were consolidated from multiple HPlcs

to a single AcQuitY uPlc H-class system, creating

a more efficient workflow.■■ the time to analyze seven water soluble vitamins

in a single run has been reduced from 50 minutes to

5 minutes – a 90% decrease. ■■ the time to analyze fat soluble vitamins (A Acetate,

A Palmitate, and e Acetate) in a single run has been

reduced from 30 minutes to 3 minutes – a 90% decrease. ■■ the custom calculations and reporting capabilities of

empower software help to streamline data processing

and review. ■■ HPlc analysis methods can be rapidly transferred to uPlc.■■ lab personnel were able to master the use of uPlc H-class

and empower software quickly and easily. the group’s

senior scientist, who has used a variety of chromatography

software packages, indicated that empower was “the most

intuitive software out there”.

■■ customer satisfaction■■ coAs can be generated more rapidly, ensuring that

customers have the product information they need

as quickly as possible.

■■ “Green” operations■■ solvent use for liquid chromatography analyses has

decreased by approximately 70 to 80%; this supports

the company’s sustainability mission, and helps reduce

sample analysis costs.

24

25

Multi-Vendor Instrument Control Minimizes Training and Validation Efforts with Empower Software Client: A Global Pharmaceutical company

BACKGROUND

the Analytical research and Development group of a global pharmaceutical company is

responsible for early-stage product characterization method development and validation.

the laboratory is equipped with approximately 20 chromatographic systems from a variety

of instrument vendors including Waters, Agilent (lc and Gc), and shimadzu.

CHALLENGE

managing a large number of HPlc systems from multiple vendors can negatively impact laboratory

productivity and increase operational costs. the Analytical research & Development group must

address a number of challenges in order to maximize their original instrument investment, including:

■■ time and effort required to train analysts on multiple software packages■■ cost and risks associated with validating multiple software packages■■ traceability of analysis results back to the original instrument chromatographic conditions

T HE SOLUT ION

to provide comprehensive control over a broad range of

chromatographic modules and connect them to a versatile

chromatography data management tool, the customer employed

Waters® empower™ chromatography Data software (cDs) for data

acquisition, processing, reporting, and distribution. empower’s

open instrument Portal (oiP) technology allows vendors to

introduce instrument control without making changes to the

empower software. empower’s integrated relational database

allows the software to link to the chromatographic results with

the original method parameters.

third-party HPlc and Gc vendors who have leveraged the oiP

technology to deploy instrument drivers for empower include

shimadzu, Hitachi, Varian, Perkinelmer, and ctc Analytics.

26

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©2008-2010 Waters corporation. Printed in the u.s.A. september 2010 720002508en lB-AP

BUSINESS BENEFIT

relying upon empower software for complete control of all chromatographic systems allowed

the company to optimize the effectiveness of instrument related workflow.

High-impact benefits for both the laboratory and organization include:

■■ minimizing the training required for chemists to efficiently operate chromatographic software

that controls existing HPlc and Gc systems by standardizing on empower.

■■ eliminating multiple chromatographic software packages that would require additional

training and validation.

■■ Avoiding the new technology implementation and validation costs that would be incurred

if the chromatography software only supported a single vendor’s instrument.

■■ the ability to apply empower’s unique compliant-ready tools to all instruments and provide

a comprehensive audit trail with traceability back to the original instrument method

conditions, combined with advanced data security and processing capabilities.

■■ reducing the time and effort required for analysts to confirm data traceability with

empower’s integrated data collection and analysis capability.

■■ increasing laboratory productivity by standardizing procedures, reports,

and maintenance of all chromatographic systems.

27

Eliminating Chromatography Data Transfer to Spreadsheets: Reducing Errors And Improving Productivity With Custom Calculations Using Empower SoftwareClient: A Global Generic Pharmaceutical company

BACKGROUND

the Analytical Development group of a global generic pharmaceutical company is responsible

for late-stage analytical development. the group transfers a number of product characterization

methods required for batch release to the Quality control group, including those tests required

for content uniformity. the laboratory is equipped with approximately 100 HPlc systems.

scientists employ microsoft excel spreadsheets to perform a variety of calculations with the data

generated from the chromatography software. the results generated from these methods are

critical, as they will ultimately determine whether or not commercialized product is released and

how quickly the corresponding revenue can be realized.

CHALLENGE

the Analytical Development group must process large sample volumes as

efficiently as possible, while generating highly accurate results. in performing

the requisite chromatographic data calculations, the group faces a number of

challenges including:

■■ Data transfer and data transfer verification.■■ transcription and calculation errors.■■ each scientist spends one to two hours per analysis performing calculations.■■ time and cost associated with software training.■■ costs to develop and maintain macros to perform calculations.■■ software and macro verification and validation.

■■ A large number of very tedious calculations.

T HE SOLUT ION

to address the time, cost, and risk factors associated with developing testing

methods for batch release, the company employed Waters® empower™

chromatography Data software (cDs) for data acquisition, management,

processing, reporting, and distribution. utilizing empower’s custom calculation

functionality, the company was able to automatically process data and

integrate the information within empower software for easy review.

28




BUSINESS BENEFIT

With empower software, the company is able to perform data acquisition and analysis

simultaneously in one integrated software package, thereby realizing a number of

high-value benefits, including:

■■ improved productivity by significantly reducing the time required for data transfer to

excel spreadsheets and its verification.

■■ using predefined tolerance levels, the software can detect out of spec values and

immediately halts problematic runs, saving the analysts’ time and reducing the cost

of solvent that would be wasted if the run were to proceed to completion.

■■ mitigating risk by reducing transcription errors.

■■ reducing the time and effort required for analysts to confirm data traceability.

■■ improved data integrity.

■■ reduced time and cost required for validation.

■■ improved overall laboratory workflow – the one to two hours required per analysis

to perform calculations was eliminated, allowing scientists to focus efforts in other

areas of the laboratory.

■■ With streamlined methods implemented in the Quality control group, testing is

performed more rapidly, facilitating batch release.

29

BACKGROUND

A global pharmaceutical company develops, manufactures, and markets dozens of prescription and over-the-counter drugs; the therapeutics

are used to treat disease conditions, including allergies, arthritis, cancer, diabetes, depression, heart disease, and HiV.

As part of its drug development and approval process, the company uses numerous analytical techniques for compound quantification,

purification, and characterization, including high performance liquid chromatography (HPlc). chromatographic method validation, the

process of establishing that the HPlc method is suitable for determining identity, quality, strength, purity, and potency of drug substances

and products, is a regulatory requirement.

Proper execution of method validation can facilitate compliance and pave the way for commercialization. unfortunately, the current process of

validating chromatographic methods is time-consuming and prone to errors, which not only negatively impacts productivity, but can also

ultimately delay the introduction of products.

CHALLENGE

the company’s multiple research and development businesses performed method validation

using a variety of tools with different capabilities that created process inefficiencies. in an

effort to synchronize method validation within the r&D units and manufacturing sites, the

company sought to implement an automated method validation solution that would incorporate

corporate-driven, template-based standard operating procedures (soPs) for managing validation

procedures, as well as providing a secure database to store results and enhance their ability to

adhere to 21 cfr Part 11 requirements.

even more important than the soP templates

that would guide the method validation

documentation process was the need to

ensure the accuracy and traceability of data.

the company wanted to enable analysts to

perform all method validation calculations

using the same chromatography data

software (cDs) they used to capture results.

this would eliminate the need to export

data to a spreadsheet for calculations, and

the potential for error in data transfer, and

simplify their validation efforts. the company

also sought to include data review and

approval functionality.

Streamlining Method Validation in Pharmaceutical Product Development with Empower Software Method Validation Manager (MVM)Client: A Global Pharmaceutical Company

A scientist with the

company’s R&D division

indicated that

Empower MVM provides

a 50% overall time

savings for non-sample

prep activities.

29

30

Waters is a registered trademark of Waters corporation. empower and the science of What’s Possible are trademarks of Waters corporation. All other trademarks are the property of their respective owners.

©2006-2010 Waters corporation. Printed in the u.s.A.september 2010 720001522en lB-AP


T HE SOLUT ION

the company selected Waters® empower™ software method

Validation manager (mVm) as the single, comprehensive solution

to satisfy all of its method validation requirements. empower

mVm is an enterprise option for the market-leading cDs platform

that addresses the limitations and bottlenecks faced

in chromatographic method validation.

With Empower MVM, analysts at the company now have the

ability to:

■■ incorporate established soP parameters within the cDs software

■■ Display the status of ongoing validation studies to guide the

user through the workflow

■■ Preemptively associate injection data to validation characteristics

■■ Automatically check data to confirm that each validation

parameter adheres to soP requirements

■■ Approve data at various steps in the workflow

■■ Perform all validation results and statistical calculations

in empower

■■ Perform multi-component analyses and batch processing of results

■■ Alert users to results that are out of specification

■■ Generate reports with standardized templates

empower mVm also assists the company in regulatory compliance

by providing audit trails, tracking injections for each validation

test, designating privileges to control user activity, and securing

traceable data within the empower 2 database.

BUSINESS BENEFIT

By implementing empower mVm, the company has automated and

significantly streamlined the method validation process.

A number of factors have contributed to an increase in overall

productivity, including:

■■ eliminating the need to transfer data to third-party software

packages for statistical calculations and reporting.

■■ reducing transcription errors and the time spent identifying

those errors.

■■ Providing inexperienced analysts with soP templates,

eliminating the need to continually refer to complex

and lengthy written protocols.

■■ the ability to manage a validation study is now cooperative

effort since each individual involved in the process can determine

what activity has completed at any time in the workflow.

A scientist with the company’s global r&D division indicated that

nonsample prep activities account for approximately 60% of the

time consumed in a method validation study. With empower mVm, he

estimates this could be reduced to as little as 10%, representing a

50% overall time-savings, as shown in table 1. Just as importantly,

the scientist said that with empower mVm, he is “more confident that

his method validation data is accurate and traceable.”

Validation task % Total validation time Time-savings with Empower 2 MVM

Administrative 20 75

sample prep 40 0

Processing data 20 95

report Generation 20 80

Total 100 50

Table 1. Method validation time savings with Empower Method Validation Manager.

31

nuGenesis PlAtform

33

Improving Data Accessibility And Intellectual Property Management with NuGenesis SDMSClient: Pharmaceutical Division of a Global Health care company

“ The solution needed

to integrate a large

corporate archive of

critical data and make

it available through one

online user interface.”

BACKGROUND

the pharmaceutical r&D division of a global healthcare company focuses on the development and

commercialization of therapeutics used in the treatment of mental illness, neurological disorders,

gastrointestinal disorders, fungal infections, allergies, and cancer. An innovator, the company

has developed dozens of drugs since its inception. the company operates a number of analytical

laboratories that utilize automated systems to analyze large volumes of samples for internal clients.

A solution was needed to integrate a large corporate archive of critical data and make it

available through one online user interface. Additionally, the solution had to integrate with

their corporate global compound registry system (Gcrs).

CHALLENGE

to satisfy electronic data management requirements for its analytical laboratories, the customer

faced a number of challenges, including:

■■ the extensive use of automated systems and robotics presented complications for

automated result distribution; often, each separate well plate is a measurement for

a different internal customer, and is therefore handled separately.

■■ Analyses have significant relevance for intellectual property protection; all patent-relevant information

had to be harvested automatically in case results that needed to be retrieved on short notice.

■■ With an open access workflow, the company needed to move from labor-intensive, lims-oriented

laboratory practices to an open, all-electronic system for scientific data management.

T HE SOLUT ION

the customer facilitated the transition to an open access workflow by implementing a number

of Waters® laboratory informatics solutions, that included the following components:

■■ NuGenesis® Scientific Data Management System (SDMS): Automatically imports disparate

data generated from instruments, scientists, and outside sources into a centralized data

warehouse. information can be searched, communicated, and shared among scientists,

thereby facilitating laboratory efficiency, regulatory compliance, and product development.

■■ MassLynx™ Software: Provides mass spectrometry data acquisition and analysis. Data

processing capabilities include application managers – software that assists with the

acquisition of application-specific data and the conversion of that data into useful information.

■■ OpenLynx™ Application Manager: Provides open access, walk-up lc/ms system operation,

as well as customizable batch processing to support the large amounts of data resulting from

high throughput analyses.

34

the solution impacted a number of areas.

Batch reports for LC/MS analyses

the customer uses automated systems to process large volumes

of samples. in many cases, the results must be extracted

from individual well plates separately. this data processing

requirement was addressed by utilizing the nuGenesis sDms Print

to Database functionality. Printed results (the actual content of

instrument-generated reports) provided by masslynx software are

automatically captured in a centralized database, where they are

indexed, made searchable, and can be shared.

Individual reports for LC/MS analyses

the open access analytical laboratory emails the results of lc/ms

analyses directly to the originator in the form of an openlynx

report file. if the compound must be registered, the user can use

Print to Database to archive the results. for u.s. sites, all data are

now automatically archived with no user discretion allowed. in

addition, a template was configured to harvest all patent-relevant

information from the customized openlynx template.

Accessibility of critical data in medicinal chemistry

A global project in medicinal chemistry had naming conventions

for all methods. A vast amount of historical data has now been

uploaded onto the nuGenesis sDms Platform from the legacy

system (almost 90,000 records on VAX/Vms). custom templates

were generated for the process of extracting critical data. search

and reporting functions within sDms enable analytical laboratory

managers to generate matrix views that correlate analytical

techniques to their respective sample analysis. this task had

previously been impossible on the legacy systems.

Global compound registration integration

the company’s Gcrs was integrated with nuGenesis sDms.

this integration allows for batch job synchronization between

sDms and Gcrs systems, allowing management to ensure that

the essential analytical data is also being archived to support a

structure registration in the Gcrs.

BUSINESS BENEFIT

the customer realized a number of benefits from their Waters

laboratory informatics implementation including:

■■ migration to a less labor-intensive open access laboratory

environment which, in turn, helped address the challenge

of staff reductions.

■■ requests from the Patent department often arrive months

after the analysis. By leveraging the tight integration between

nuGenesis sDms and microsoft office products, it is now

possible to use an excel spreadsheet of registry numbers to

look up data in the sDms archive. regardless of how much time

has passed, critical intellectual property information can now

be accessed quickly and easily.

■■ Analytical data from third-party instrumentation have been

integrated within nuGenesis sDms, with specific fields

available for critical sample information such as purity,

retention time, molecular ion, analytical method files, etc.

■■ the accessibility of all analytical data has improved the flow

of drug candidate information between the customer’s

discovery, development, production, and quality control

groups. A well-connected product development lifecycle has

yielded gains in efficiency and reduced the time required

for commercialization.


Waters and nuGenesis are registered trademarks of Waters corporation. masslynx, openlynx, empower, and t he science of What’s Possible are trademarks of Waters corporation. All other trademarks are the property of their respective owners.

Waters nuGenesis sDms is covered under a formal Quality management system certified by lloyd’s register Quality Assurance.


35

Employing a Bioanalytical Data Management System to Increase Workflow Efficiency Client: A global pharmaceutical companyProduct: nuGenesis® scientific Data management system (sDms)

The amount of paper

generated per run has

been reduced by 90% –

a savings of 56,000 sheets

of paper at a single site.

BACKGROUND

the client is a global health care company focused on patient needs, and they

offer a range of essential health care assets. the company discovers, develops,

and markets a variety of innovative therapies worldwide. extensive research and

development efforts are focused largely on health care challenges in oncology,

diabetes and metabolic disorders, as well as thrombosis, internal medicine,

central nervous system disorders, and vaccines.

CHALLENGE

A recent merger combined numerous laboratories and scientific processes,

including those groups involved in bioanalysis. After the merger, the company’s

bioanalysis laboratories employed three different systems to manage analytical

data. the systems included Perkinelmer’s sQl*lims, thermofisher’s sample

manager, and innaphase’s (now thermofisher) Watson lims. the typical workflow

that resulted, including sample handling and analysis documentation, proved to

be less than optimal. challenges included:

Compliance management

■■ 21 cfr Part 11 compliance was inconsistent from site to site.

Paper-centric legacy processes

■■ filling out, reviewing, collating, moving, and storing paper records

was very time consuming.

■■ mining information from the paper records was difficult and inefficient.

Operating costs

■■ each analytical run produced 70 to 100 sheets of paper.

Annually, nearly 100,000 sheets of paper were printed and stored.

in addition to streamlining workflow, it was the desire of the bioanalysis groups to

significantly reduce the amount of paper generated and stored during the course of

standard operations.

36

SOLUT ION

Bioanalytical data management system

to reduce the volume of paper generated and increase overall workflow efficiency, the company implemented a bioanalytical data

management system comprised of the following:

NuGenesis SDMS

■■ With Waters® nuGenesis sDms, data from a wide variety of

sources, including instruments and analysts, can be readily

imported and indexed within a centralized electronic data

warehouse. once collected, this information is easily

searched, communicated, and shared.

■■ All lc/ms/ms data from bioanalysis studies, including printed

reports, are stored in nuGenesis sDms. the ms systems are

from multiple vendors.

■■ Peak areas and final reports are exported from nuGenesis

sDms directly into Watson lims.

■■ After a study is completed, all electronic data is securely

archived according to GlP regulations using the electronic

signature functionality of nuGenesis sDms.

Watson LIMS

■■ A specialized, protocol-driven lims designed to support

bioanalytical studies in drug development

■■ Watson lims contains all the information about the design of

a study, including subjects, treatments, timings, and samples.

it also contains the logistic information and bioanalysis run

information, as well as the final concentrations.

The QA review process – before and after Before the bioanalytical data management system:

■■ Analysts collated all paper run reports, sample logs, lims

printouts, and final reports. material was then physically

transported to Quality Assurance (QA).

■■ QA audited the reports, and eventually provided a final signed-

off report – this process required a minimum of five days.

After the bioanalytical data management system:

■■ the QA analyst receives a printed copy of the report and audits

against electronic records and the report from Watson lims to

ensure data transfer has been performed correctly.

■■ Approvals are done electronically using the built-in function

of nuGenesis sDms, and no longer require handwritten

signatures on paper reports.

With NuGenesis SDMS, data from a wide variety

of sources, including instruments and analysts,

can be readily imported and indexed within a

centralized electronic data warehouse.


BUSINESS BENEFIT S

the client’s bioanalytical laboratories have realized significant gains in workflow efficiency, as well as cost reductions through the

implementation of a bioanalytical data management system. Benefits include:

Greater productivity

■■ review steps for analyst, checker, and principal investigator

have been eliminated. the reduction in Qc review time has

saved approximately 45-man days per year for the eight-

person team.

Reduced costs

■■ the amount of paper generated per run has been reduced

by over 90% – a savings of 56,000 sheets of paper at

a single site.

Validation effort

■■ By using a standard rollout/configuration, validation has

been simplified, and is performed only once.

■■ leveraging vendor validation services, as encouraged by

GAmP5, has further reduced the time and effort required

for validation.

Compliance management

■■ the automatic capture and securing of instrument data, final

reports, and lims data by nuGenesis sDms have assisted the

company’s laboratories in meeting regulatory requirements.

37

Waters and nuGenesis are registered trademarks of Waters corporation. the science of What’s Possible is a trademark of Waters corporation. All other trademarks are the property of their respective owners.

nuGenesis sDms is covered under a formal Quality management system certified by lloyd’s register Quality Assurance.

©2010-2012 Waters corporation. Produced in the u.s.A.march 2012 720003236en lB-PDf

INCREASING EFFICIENCY IN MANUFACTURING QUALITY CONTROL WITH NuGENESIS SDMS Client: Waters Corporation, Liquid Chromatography Column Manufacturing Facility

BACKGROUND

Waters corporation operates a liquid chromatography column manufacturing facility in Wexford,

ireland that produces over 95% of all columns sold by Waters. the department employs

approximately 70 people, including six production support analysts and two chemists.

facility production volume is up to 5,000 units per week, and includes Waters® symmetry,®

Atlantis,® Xterra,® AcQuitY,® and XBridge™ column brands. column packing materials are supplied

by another Waters manufacturing facility located in taunton, massachusetts. columns are used

for both Waters and third-party liquid chromatography systems, and are shipped to thousands of

customers in locations around the world.

CHALLENGE

A critical step in the column manufacturing process is the review of outgoing customer orders

prior to packaging and shipping. the reviewer’s primary responsibility is to inspect product

quality and associated paperwork; however, reviewers are also required to manually enter data

for 14 categories of column detail information, such as efficiency, back pressure, retention time,

batch number, part number, serial number, etc. in total, 56,000 manually transcribed entries

are made per week – a laborious, time-consuming process. in addition, all column detail data are

archived on DVD’s. Accessing this information for customer inquiries regarding products in use

may require up to 2 hours of the analyst’s time, potentially reducing productivity and increasing

response time.

The time for a reviewer

to input product data for

one 96-piece customer

order has been reduced

by 50%... reviewers

are able to focus even

more time on quality

improvements.

39


T HE SOLUT ION

in september 2006, the Wexford facility implemented Waters

nuGenesis® scientific Data management system (sDms). With

sDms, data from a wide variety of sources, including instruments

and analysts, can be readily imported and indexed within a

centralized electronic data warehouse. once collected, this

information can easily be searched, communicated, and shared.

in the Wexford application, sDms interacts with Waters’ empower™

chromatography software via its Print-to-Database functionality

– as reviewers print column test chromatograms, sDms

automatically catalogs and captures the pertinent information,

and saves it to the database. information on the column, including

a hyperlink to the corresponding chromatogram, can be instantly

retrieved anytime, from multiple geographic locations.

BUSINESS BENEFIT

the implementation of sDms has afforded a number of benefits to

the Wexford facility’s order fulfillment workflow, including:

■■ Risk reduction – the automatic capture of column detail information with sDms has reduced the data entry error rate to nearly 0%. During the Print-to-Database operation, a template ensures that all relevant indexing information is captured for each chromatogram, thus providing automated error proofing.

■■ Greater productivity – the time for a reviewer to input product data for one 96-piece customer order has been reduced by 50%.

■■ Better quality – With less time required for data entry, reviewers are able to focus more time on quality improvements.

■■ Process optimization – sDms provides rapid trending of column test data. results are instantly accessible to the Waters taunton facility staff, which allows them to make any necessary adjustments during the packing material production process, and optimize column performance specifications. the end result is an improvement in batch-to-batch reproducibility and delivery of a consistently performing product.

■■ Enhanced collaboration – electronic storage of column performance records means that data can be easily shared between the taunton and Wexford facilities on a 24/7 basis.

■■ Faster customer service – By simply entering a particular

serial number into sDms, an analyst has instant access to

archived column Qc data. customer inquiries on column

performance can be addressed immediately, which helps

minimize disruptions to the customer’s workflow.

Waters, symmetry, Atlantis, Xterra, AcQuitY, and nuGenesis are registered trademarks of Waters corporation. XBridge, empower, and t he science of What’s Possible are trademarks of Waters corporation. All other trademarks are the property of their respective owners.


sDms Vision Publisher is covered under a formal Quality management system certified by the tÜV rheinland Group.


40

41

Improving Data Management and Accessibility Across Multiple Geographies with NuGenesis SDMSClient: A Global technology-Based manufacturing organization

BACKGROUND

the technology division of a global plastics manufacturer has several hundred employees

working in six business divisions located in north America, europe, and Asia. like many

scientific organizations, the customer found it challenging to manage, transfer, review,

and report technical data and information across multiple geographic locations.

CHALLENGE

the technology division is comprised of product developers, platform chemists, analytical

chemists, and technicians located at eight different sites worldwide. single-point instrument

data were captured electronically and stored in a lims; multi-point data were often stored in

paper format. reports and presentations had different storage formats and sites. Historical

knowledge was difficult to access globally – sometimes it was lost entirely.

T HE SOLUT ION

to address this challenge, the customer chose to implement Waters® nuGenesis® scientific

Data management system (sDms). nuGenesis sDms automatically captures data from various

applications as either raw data, or as a printed report, and builds a catalog containing metadata

(data about the data). Any authorized user can access the data (chromatograms, spectra, and

reports) via a web-based browser. the modular architecture of the sDms system lends itself to

customization to suit business needs.

What dictates the system architecture?

to minimize the impact on speed, a single server was ruled out. operational centers in north

America, Asia, and europe were designated as sites for regional servers. each site connects to

all three servers through one interface.

Who supports the system?

there is a global help desk. A global administration team from the customer’s technology

function, not it, oversees system support.

What is the best way to ensure that features map to business-critical systems?

two stages of data modeling ensured that the system would meet the requirements of the user base.

it was critical that the system meet user expectations at launch so that the users could see the time

savings and immediate benefit.

“ We found that

teaming with Waters’

experts and good

up-front planning

were critical to

our successful

implementation.”

42


Waters and nuGenesis are registered trademarks of Waters corporation. t he science of What’s Possible is a trademark of Waters corporation. All other trademarks are the property of their respective owners.



the first data modeling stage was a big-picture analysis of how the

system would function; the second stage dealt with views, privileges,

soPs, and templates. in addition, planning was necessary for lims

interfacing and password synchronization among three servers.

the customer found that one of the most valuable facets of the

data modeling experience was having a Waters system engineer

assist during the data modeling session. the customer found that

teaming with Waters’ experts and good up-front planning were

critical to their successful implementation.

How does Waters ensure long-term system sustainability?

measuring how many documents are printed and archived per

business and per site, as well as monitoring retrieval statistics

allow maintenance, upgrade efforts, and refresher training to

be directed to the appropriate sites and/or business units.

the total number of print data records grew from 8,144 in the first

full quarter after implementation to 142,000 by the end of the

third quarter. roughly 55% of those records came from migrating

legacy repositories into sDms to make them text searchable;

38% were laboratory data, and 7% included other reports and

project documentation.

What was the biggest lesson learned during implementation?

it was important to spend several months populating the system

with legacy data before rolling out the application. this enabled

the customer to verify the data model, and provide a base

repository supporting initial activities. Doing this made nuGenesis

sDms a tool that users wanted to use daily as soon as it was

available, as opposed to being trained on a relatively empty

system where they wouldn’t see immediate benefits.

BUSINESS BENEFIT

By tracking and categorizing one week of activities into value-added

categories (research, notebook documentation, and writing papers)

and non-value-added categories (managing paper files, looking for

data, faxing, and email data), the customer determined that they

could realize a 10% time savings globally by using nuGenesis sDms.

Additionally, the customer calculated that the number of paper

records that could not be located after several years, and the

calculated fraction of the analytical budget used to generate those

data were enough – together with the activity mapping – to justify

their investment in nuGenesis sDms.

other benefits that resulted from the nuGenesis sDms

implementation include:

■■ increased speed of new product introduction.■■ leveraging global talent and bringing new sites up to

speed more quickly.■■ reducing transcription errors with paperless laboratories.■■ instant availability of multi-point data.■■ enabling transparent, consistent global processes.■■ the ability to work across time zones.■■ Avoiding work redundancy.

■■ People locating data themselves rather than submitting a request.

implementation of a nuGenesis sDms data repository created a

paradigm shift in the way that this large, global technology-based

manufacturing organization has been able to archive and communicate

technical data. A solid implementation enabled the customer to reap

many benefits, from cost-out productivity of streamlining processes

and reducing the time spent on managing data, to sharing important

information and knowledge with scientists around the world.

43

21 CFR PART 11 Compliance with NuGenesis SDMSClient: A Biopharmaceutical Company

BACKGROUND

A us-based biopharmaceutical company is engaged in the discovery, development, and

commercialization of medicines used in the treatment of diabetes, obesity, and cardiovascular disease.

the company is primarily focused on investigating the potential utility of

new peptide hormone candidates, and has significant research and clinical

expertise in metabolic medicines. they have developed a proprietary

library of novel synthetic polypeptides to identify and characterize the

activity of both known and unknown peptides.

the company has a number of therapeutics in various stages of clinical

development and is subjected to continual regulatory scrutiny.

CHALLENGE

to satisfy us fDA regulatory demands, the company must comply with 21

cfr Part 11 guidelines for the backup and archival of critical laboratory data.

specifically, they required a data management solution that allowed for

document lock-down and revision control for microsoft excel spreadsheets.

their process involved manually transferring data from paper reports to

excel spreadsheets. the spreadsheets required 100% quality verification

to ensure the integrity of the data. this verification process was very labor

intensive and prone to transcription errors, all of which had to be identified and corrected.

T HE SOLUT ION

the company selected the Waters® nuGenesis® scientific Data management system (sDms) for

its ability to automatically import disparate data generated from instruments, scientists, and

outside sources into a centralized information warehouse. With nuGenesis sDms, data can be

easily searched, communicated, and shared among scientists, thereby facilitating laboratory

productivity, product development, and regulatory compliance.

Waters’ enterprise software solutions (ess) team worked closely with the customer on all aspects of

the nuGenesis sDms application deployment. the deployment consisted of the following components:

■■ File Capture – Allows any kind of file data to be automatically captured, cataloged, and secured.

■■ Print Capture – Allows print data (the actual content of instrument generated reports) to be

captured, indexed, and secured in high fidelity.

44

■■ UNIFY templates – extracts valuable data from captured printouts

for cataloging and later retrieval.

■■ Auto Extraction templates – Automates search and extraction

of pertinent data, and the exportation of the data to external

applications for additional calculations.

■■ Application Control Manager (ACM) – Provides a secure,

compliant framework for using microsoft office applications,

including Word, excel, and PowerPoint.

■■ Software Development Kit (SDK) – for custom programming

using nuGenesis sDms functionality, such as specialized

integration with legacy software.

the system was configured and data modeled to support multiple

file capture and Print capture applications types.

Waters was responsible for the execution of the installation and

operational Qualification (iQ and oQ) workbooks, which test

the installation and operation of the base system. Waters also

provided customized Performance Qualification (PQ) scripts that

test business processes, and verify that the appropriate standard

operating procedures (soPs) are in place, to ensure that the

system meets the requirements for its intended use.

A driving force for implementing nuGenesis sDms was its

seamless integration with microsoft excel. the solution’s

functionality gave the company the ability to control and extract

data to excel spreadsheets with the highest confidence.

Waters’ ess team partnered with the customer to define

the requirements for the Auto extraction templates to

support Analyst and softmax Pro reports. this enhancement

gave the company the ability to extract the maximum number

of data points required into excel.

Waters coordinated the creation of the functional specifications,

product development, testing, and iQ/oQ/PQ for the installation

and validation testing of the Auto extraction enhancement.

BUSINESS BENEFIT

this biopharmaceutical company is 21 cfr Part 11 compliant in

their labs for backup, archival, and retrieval of critical clinical and

pre-clinical data. With the nuGenesis sDms solution, they have

dramatically improved their ability to control validated spreadsheets.

the scientists can transfer data automatically to the controlled excel

spreadsheets without requiring data quality verification.

the use of Auto extraction for Analyst and softmax Pro reduced

turnaround time from 30 minutes per report for manual entry,

to one minute for the automated solution. on average, this has

reduced the time required for data entry by more than five hours

per week. now the company’s quality department can perform spot

audits of the data, rather than the 100% verification after manual

data entry.

the company plans to deploy nuGenesis sDms in all of its labs.

Application control manager (Acm) will be used to control

validated spreadsheets. Additionally, Acm will be used to

control an electronic laboratory logbook.





45

BACKGROUND

A large generic pharmaceutical company has research, development, manufacturing, and

distribution operations worldwide, including north America, south America, europe, Asia,

and Australia.

the company’s ongoing goal is to maximize return on investment in r&D by reducing the time

required to develop and commercialize new products.

A number of strategic initiatives were launched to achieve this goal, including the implementation of

Waters® laboratory informatics solutions. Waters nuGenesis® scientific Data management system

(sDms) plays a vital role in automating scientific data entry into the company’s electronic common

technical Document (ectD), a standard electronic format for regulatory submissions.

the ectD is an advanced method used by pharmaceutical companies to assemble and submit

regulatory submissions to regulatory bodies around the world, including the us fDA, Health

canada, Japan’s ministry of Health, labor and Welfare; and the european union’s european

medicines Agency.

this represents a unique set of challenges for electronic record and data management. Data and

records must be archived in a compliant, secure database that protects the integrity of e-records

from tampering and loss throughout their relevant retention periods.

CHALLENGE

the company required an electronic solution that provided information management capabilities

that were superior to legacy paper documentation and workflow archiving. the solution

needed to address a number of key business drivers, including:

■■ securing new product exclusivity by optimizing the regulatory submission process■■ responding to regulatory and industry initiatives by implementing common standards

for e-submissions and e-information exchange■■ maximizing return on investment in r&D■■ reducing product development and commercialization time

■■ increasing productivity and efficiency while decreasing costs

T HE SOLUT ION

the company selected nuGenesis sDms as the cornerstone of its strategic initiative to establish

a worldwide corporate information management, exchange, and submissions system.

SDMS plays a vital role in

handling scientific data

entry into the company’s

electronic Common

Technical Document

(eCTD) for regulatory

submissions.

Optimizing Efficiency with Electronic Regulatory Submissions with NuGenesis SDMSClient: A Generic Pharmaceutical company

46


Waters and nuGenesis are registered trademarks of Waters corporation. the science of What’s Possible is a trademark of Waters corporation. All other trademarks are the property of their respective owners.



their electronic regulatory submissions project, initiated in 2001,

employed an integrated software solution that combined several

core applications:

■■ Waters NuGenesis SDMS: Automatically imports disparate data

generated from instruments and outside sources into a centralized

data warehouse. information can be searched, communicated, and

shared among scientists, thereby facilitating laboratory efficiency,

regulatory compliance, and product development.

■■ Broadvision One-to-One Document Management System:

Provides content management of business documentation in

microsoft office formats and Xml with e-signature workflow,

and integrated PDf and web publishing.

■■ Lorenz docuBridge: combines content collected by nuGenesis

sDms and Broadvision in an ectD document for submission.

the nuGenesis sDms implementation began in early 2002.

the first phase of the deployment concentrated on four north

American sites and was completed in less than two years.

of primary interest to the customer was the utilization of the sDms Print

capture technology, which captures, indexes, and secures the actual

content of instrument-generated reports. the company relies on Print

capture for scientific data capture, metadata extraction, and archival

from a variety of data sources, including Perkinelmer’s totalchrom

chromatography software, Agilent’s chemstation and chemstore

chromatography software; lims, and other supporting systems.

During the software integration phase, Waters’ enterprise

software solutions (ess) group worked closely with a cross-

functional team that included the company’s corporate regulatory

operation and it departments. the Waters ess team provided post-

deployment business and technical support, as well as maintenance;

incorporating critical feedback from the customer to ensure

continuous improvement.

the successful validation of key software solutions is an essential

component of any major deployment. the validation for this solution

consisted of two stages: first, the core applications, and second,

the individual site-specific rollouts. timelines were 7 months for

the core application iQ/oQ, and 4 to 11 months for the iQ/PQ

site-specific data configuration.

BUSINESS BENEFIT

nuGenesis sDms now plays a vital role in handling scientific data

entry into the pharmaceutical company’s electronic common

technical Document (ectD) for regulatory submissions. the

ability to be the first to register and obtain approval for a new

pharmaceutical product yields six months of exclusivity and

significantly enhances revenue potential.

moving to an all-electronic scientific and business information

management strategy that facilitates workflow for laboratory

scientists making their final regulatory submissions has yielded

great gains in efficiency.

the availability of scientific data through nuGenesis sDms has

increased the company’s productivity, and serving as a single point

of access for all information regardless of geography, sDms has

helped the company substantially reduce their operational costs.

finally, in an environment of increased scrutiny by global

regulatory inspectors, the company has enhanced its competitive

and strategic positioning by improving its ability to readily

satisfy compliance.

collectively, these benefits have allowed the customer to reduce

product development and commercialization times.

47

Optimizing Image Data Processing and Storage for Drug Development with NuGenesis SDMSClient: A Pharmaceutical Division of a Global Health care company

BACKGROUND

A pharmaceutical subsidiary of a global healthcare company is focused on the development

and commercialization of therapeutics that are used for treating mental illness, neurological

disorders, gastrointestinal disorders, fungal infections, allergies, and cancer. An innovator,

the company has developed dozens of drugs since its inception.

to support their discovery and development efforts, the company uses a number of analytical

techniques, such as multi-mode high throughput screening (Hts) in well plate microscopy

systems. these systems are typically used for target identification, target validation, assay

development, Hts, hit-to-lead, deep pharmacology, and ADmet analysis. the vast amount

of data produced is typically generated in the form of electronic images.

CHALLENGE

the customer needed to support image-driven research in a medium-to-high data

throughput environment.

managing the capture, storage, and retrieval of large volumes of image data can present a

variety of problems for pharmaceutical organizations. secure information storage can be

cost prohibitive unless the system is well designed, and the business benefits are prioritized.

using numerous localized DVD/cD backups for data storage limits the accessibility of this

valuable information, preventing full utilization of a corporate resource.

“The scientific image

data management

system deployment

has revolutionized

the company’s

ability to process

and store large

amounts of

image data at

acceptable costs.”

SYSTEM

ADMINISTRATOR,

GLOBAL HEALTH

CARE COMPANY

47

48

THE SOLUTION

the customer implemented Waters® nuGenesis® scientific

Data management system (sDms), which automatically imports

disparate data generated from instruments, scientists, and outside

sources into a centralized data warehouse. information can be

searched, communicated, and shared among scientists, thereby

facilitating laboratory efficiency, regulatory compliance, and

product development.

for this implementation, the nuGenesis sDms Platform was

combined with a customized user interface and a carefully

developed and tested raw data file archiving strategy. the solutions

comprise a scientific image data management system (siDms).

this siDms provides optimal support for working with image data – from

local workstations to a customized, unified workbench environment –

that relies on gigabit network connectivity between building blocks.

Key to this successful deployment was its integration with an

affordable alternative for managed storage of large quantities of

images: Advanced Digital information corporation’s (ADic) total

data lifecycle management system.

With the ADic system, data are captured from multiple operating systems

that are connected to multiple devices via the storage area network.

original data files are captured and indexed by the nuGenesis sDms

automated file capture agent; sDms provides central data management

of the online and archived data. the platform’s offline storage manager

(osm) provides this control to an ADic storage area network and tape

library system. A customized unified workbench then facilitates the

retrieval of desired files from the archive to a local workstation. this

restoration service is robust and takes advantage of the high-speed

network between the individual components of the solution.

Because of the large volume of data, the network was upgraded to

a dedicated one GB network between client computers, servers, and

their offline storage systems. the sDms software Development

Kit (sDK) was used to develop custom integration tools to

interface with ADic library software. special functionality was

included for uploading and downloading large image datasets.

iterative tests on 800 GB of data yielded a performance of 5 GB

per hour net capture of file data to the ADic library system, and

7 GB per hour net retrieval from the ADic system to the client.

Assuming a 50% uptime, the system provided capture and

restore capabilities of 400 GB per week, and 600 GB per week,

respectively.

BUSINESS BENEFIT

the scientific image data management system deployment has

revolutionized the company’s ability to process and store large

amounts of image data at acceptable costs. the combined

nuGenesis sDms-ADic technology can be leveraged for virtually

any type of scientific data. Benefits include:

■■ elimination of decentralized and unmanaged DVDs/cDs

■■ Added value to major investments in image acquisition

and processing infrastructure

■■ Providing data from service labs to client research

departments is simple and flexible

■■ offline image data processing, which enables the company to

increase its Hts capacity, as well as its ability to gain new

insights into results by reprocessing image sets

the Waters nuGenesis sDms-ADic strategy to build a siDms

solution has provided the customer with a unified workbench that

delivers image data to the fingertips of the researcher. robust

services transparently manage the end-to-end data flows, with

functional and performance tests exceeding the initial objectives

of data security and throughput.





Regional Healthcare Laboratory Automates QA/QC Process Workflow with NuGenesis ELN The Client: regional Pharmaceutical QA laboratory, uK national Health service

BACKGROUND

the West midlands regional Pharmaceutical Quality Assurance (QA) laboratory, which is part

of the uK national Health services (nHs), provides pharmaceutical QA/Qc advice to health

care professionals within the region. it is the center for reporting and monitoring of defective

purchased medicines, pharmaceutical specials, and medical devices used in pharmaceutical

manufacturing and administration. the lab provides QA support and assessment to the nHs

supplies central Division Drug contract for purchased medicines used in primary and secondary

care, as well as screening of herbal medicines for illicit active pharmaceutical ingredients.

testing and certification is carried

out in the areas of piped medical gas systems and pharmaceutical clean rooms.

in addition, the lab provides services for audits of unlicensed aseptic manufacturing units as

pharmaceutical QA/Qc services to the university Hospital Birmingham nHs foundation trust.

When a sample arrives in the laboratory, compliance and validation analysts review the

standard operating procedure (soP) documents, and record a notebook entry with reference to

the batch number. Analysts perform the necessary regulatory checks and transfer the sample

to the technicians for analysis, according to the appropriate soP. After all analyses have been

completed and recorded in the notebook, the batch is signed by the validation analyst and the lab

manager who oversees the analyses. the results are then transferred into a trend analysis sheet,

which is presented to the releasing officer for approval. the releasing officer then enters this data

in a lims and determines the fate of the batch.

CHALLENGE

the pharmaceutical QA lab has always operated with a multiple paper notebook system. the

analysts spent a significant amount of time locating the paper notebooks that corresponded

to a particular analysis. this logistics dilemma was exacerbated by an increasing sample load

due to the inclusion of healthcare trusts from an expanded geographic area; the additional influx

of samples was projected to continue into the foreseeable future.

in an effort to address inefficiencies inherent to their paper notebook system, as well as their

increasing workload, the customer sought to implement a structured electronic solution. the

solution would be required to provide an exact 1:1 copy of their current workflow.

NuGenesis ELN reduced the

time spent on data entry,

searching, checking, and

cross-checking information

in manufacturing analysis

by 20%.

49


Waters, nuGenesis, and Alliance are registered trademarks of Waters corporation. empower and the science of What’s Possible are trademarks of Waters corporation. All other trademarks are the property of their respective owners.

nuGenesis eln is covered under a formal Quality management system certified by the tÜV rheinland Group.



T HE SOLUT ION

the Waters® nuGenesis® eln is an electronic laboratory notebook that provides customers with the ability to transition from a paper-based to a more automated laboratory process that encompasses the entire scientific content lifecycle, which includes discovery, development, production, and QA/Qc. nuGenesis eln is designed to provide a seamless interface to analytical processing tools and other software programs, such as microsoft excel, Word, or chromatography data software (cDs), such as Waters empower™ software, used everyday in the laboratory. nuGenesis eln allows for the automation of scientific content collection and storage while satisfying compliance requirements, including e-signatures and audit trails.

in this deployment, nuGenesis eln was scaled to process approximately 2,000 analysis orders per year using approximately 600 different substance templates. the initial deployment concentrated on template development, and has been expanded to include regional sample templates, as well as experimental data harvesting.

templates were created in nuGenesis eln for three primary groups of analyzed substances: raw materials, finished products, and ad hoc samples. the laboratory tests approximately 150 different raw materials and approximately 150 finished products; it then assigns an individual template for each product according to soPs and working instructions. the technicians are provided with a fixed identification code and a signed soP document for each raw material. this signed soP is available within the respective raw material analysis templates in nuGenesis eln as a PDf document. excel template objects can be locked, so that only the required fields can be edited.

the QA laboratory also makes use of trend documents for both raw materials and finished products, so that the various substances can be monitored over their entire lifetimes. this trend document is created for each product iD when the soP is created. results from each analysis of of a particular substance over time

are copied from the certificate of Analysis and pasted into the trend document. the trend documents are stored as separate

experiments within nuGenesis eln.

BUSINESS BENEFIT

implementation of nuGenesis eln has allowed the West midlands Pharmaceutical QA laboratory to realize significant gains in analyst productivity. for manufacturing analysis work, time spent searching for information was reduced by approximately one-half day per week per analyst, and the time required for checking, cross-checking, and data entry was reduced by another half day per week; this represents 20% of analyst time that can be allocated to other tasks. for regional lab studies, approximately one day per study per month was also saved.

in addition to productivity gains, nuGenesis eln has contributed to the reduction of calculation errors by automating the conversion to validated data entry templates. nuGenesis eln has also eased the burden of compliance by providing the ability to immediately comply with increased regulatory pressure to track out-of-specification results and associated exception reports.

other nuGenesis eln functionalities of particular utility to the lab include integrated messaging and data viewing. the integrated messaging system, which notifies users of upcoming action items and related record changes, proved very useful for controlling analytical workflow. integrated data viewing has allowed the customer to visualize data (in a single interface) that was produced from an extensive instrument park that includes thermo nicolet ftir, thermo unicam uV, Waters Alliance® HPlc, Agilent

HP1100, finnigan lc/ms, and totalchrom Gc.

50

Automation of Doping Control Applications with NuGenesis SDMS And TargetLynx Client: Karolinska University Hospital, Sweden

BACKGROUND

the Doping control lab of the Karolinska university Hospital in stockholm, sweden is one of 33 doping control labs worldwide accredited

by the World Anti-Doping Agency (WADA). the lab’s nine chemists and lab technicians analyze approximately 7,500 samples annually,

including 4,717 athlete samples (compared to 183,337 samples worldwide). 87 positive samples were found at the Karolinska lab in 2006

(3,909 worldwide), using hyphenated chromatographic techniques such as Gc/ms, Gc/nPD, and lc/ms/ms.

Karolinska’s Doping control lab receives samples from a variety of customers, including the swedish sports confederation, WADA,

and other international sports confederations, as well as from correctional institutions and public health services.

the Doping laboratory is primarily financed by payments for analyses performed; therefore the more samples that are run and results

secured, the more income is generated to finance research and extended testing.

CHALLENGE

WADA’s World Anti-Doping code provides an internationally

standardized list of prohibited substances for athletes, both in and

out of competition, as well as specific regulations for particular

sports disciplines. A laboratory’s work is assessed by WADA

on the basis of a “proficiency testing program”, which must be

successfully completed if the laboratory is to retain its status as

an official doping control laboratory.

the Karolinska lab focuses specifically on testing for the 44 diuretics

and other masking agents, as well as the 58 stimulants listed in

the WADA code. in the future, they are planning to add tests for

narcotics and beta-blockers to their spectrum.

tests for diuretics and narcotics have been conducted using

Gc/ms, involving complex sample preparation with hydrolyzation,

extraction, and derivatization. stimulant tests using Gc/nPD

involve similarly complex preparation steps.

increasing regulatory pressure and introduction of new technologies

have driven up the number of samples analyzed and increased the

quality of data produced.

managing information and controlling the flow of data were major

challenges. enhancing the lab’s information and knowledge

management processes is an area where Waters laboratory

informatics has played a crucial role.

T HE SOLUT ION

new analytical methods have been introduced using lc/ms/ms. the

sample preparation for this method is now significantly easier, since

a diluted urine sample can be directly injected into the instrument

with an internal standard added. this allows for more samples to

be prepared and analyzed.

the solution chosen by the Karolinska Doping control lab is

the Waters® AcQuitY uPlc® system with a BeH shield rP18

column, 50 x 2 mm, 1.7 µm, with a flow rate of 0.4 ml/min

(meoH/nH4oAc 10 mm gradient, 6 min). A Qc sample is run at every

12th injection; water and urine are used as blanks. for detection,

Waters’ Quattro Premier™ Xe tandem quadrupole mass spectrometer

is operated in mrm mode. the instruments are controlled by Waters’

masslynx™ software, with processing and reporting done using the

targetlynx™ Application manager. targetlynx is specifically designed

for quantitation and specific analyte confirmation, and it streamlines

and automates the analysis of samples.

All raw instrument data are automatically and securely captured

and stored within Waters’ nuGenesis® scientific Data management

system (sDms).

51


Waters, AcQuitY uPlc, nuGenesis, and uPlc are registered trademarks of Waters corporation. Quattro Premier, masslynx, targetlynx, and t he science of What’s Possible are trademarks of Waters corporation. All other trademarks are the property of their respective owners.



the Karolinska lab has found that with the uPlc® system, they

can now screen up to 105 analytes in 8 minutes, injection to injection.

the hospital uses targetlynx Application manager to find analytes

that comply with three criteria:

■■ correct retention time■■ Above signal-to-noise

■■ Above concentration threshold

if a positive hit of an illegal drug is detected, targetlynx will

flag this analyte.

Having automated the analysis and post analysis calculations,

they were still faced with the need to manually review 140

compounds per sample and determine the positive hit patterns.

today, there are more than 100 samples in each batch. this

manual process is tedious and time consuming, where mistakes

can easily be made. most samples are negative (only 2.5% of

samples are positive).

the next step was to automate and streamline the targetlynx

report utilizing the Print capture capabilities within nuGenesis sDms.

Analysts now print all reports into sDms with a targetlynx format, that

includes the stimulants, ephedrines, and diuretics as individual

reports. these reports are normally several hundred pages long.

When analysts run the custom application provided by the Waters

enterprise software solutions (ess) group, they have the choice of

defining the batch number by parameters that include standards,

controls, and blanks. then all reports can be extracted from a

particular batch, excluding all standards, Qcs, and internal control

analytes. Qc results are automatically exported to their lims.

the end result is an sDms report of analytes that were found,

detailed by batch number and name of compound. Within this

“hit list”, users can click a link and sDms outputs the printed

targetlynx report that is stored within sDms. Analysts can

review the report like they always have, but now they only have to

concentrate on verifying the true positive hits (approximately 187

per year) instead of reviewing all 7,500 reports.

BUSINESS BENEFIT

the Waters solution is providing a number of benefits to the

Karolinska university Hospital’s Doping control laboratory

operations including:

■■ Increased revenue potential – Greater sample throughput

with uPlc/ms/ms.

■■ Greater productivity – Approximately two hours are saved

per batch in reviewing results for illegal compounds with

sDms and targetlynx reports.

■■ Reducing risk of data loss – sDms automatically manages

raw data backups from all lc/ms instruments.

■■ Better data accessibility – All reports and raw data are fully

text searchable from within sDms, reducing the time needed

to locate critical information.

■■ Connecting science to the business of the hospital –

targetlynx and sDms have automated and streamlined

results calculations, review, and consolidated reporting.

52

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BACKGROUND

the Physical chemistry group at a major pharmaceutical company was created to support

discovery projects in hit identification, lead identification, and lead optimization phases

with early physicochemical data gathering. the Discovery groups send test requests for

selected compounds simultaneously to respective departments via the chemical support (cs)

team within the chemistry department. the chemistry department is where all synthesized

compounds are collected and stored. compounds are sent out for testing according to the

requests, as either standard stock solutions or solid samples.

the Physical chemistry group is made up of three analytical chemists running two lc/uV/ms

systems. each of these systems consist of a Waters® Alliance® Ht system with a 2996

Photodiode Array (PDA) Detector, and a ZQ™ mass Detector, running on masslynx™ software.

testing is done in a 96-well plate format.

Among the analyses performed by the team are identification, purity, stability, and solubility

tests. iD and purity evaluations are always included in all solubility and stability tests and

demand additional processing of data.

CHALLENGE

A screen solubility test of 48 samples took approximately

51 hours of analyst time, from the time that the samples were

received to when the data was entered into the database. for a plate

containing 48 duplicate samples, the variety of tasks involved:

■■ 4 hours doing sample prep and running the samples

■■ 18 hours in the office collecting compound and plate

information – codes, predicted properties, structures,

and creating appropriate sample lists

■■ 8 hours evaluating purity

■■ 19 hours doing the solubility calculations

■■ 2 hours inputting the final data into the company’s database

the analyst would get results over a week later. the Physical

chemistry group recognized that testing results were taking too

long. they needed to significantly reduce bottlenecks in data

management and analysis, as well as instrument resources, to

improve their ability to support discovery projects – especially

since incoming work volume was increasing.

Increasing the Throughput of Physiochemical Profiling with ProfileLynx Application Manager for MassLynx SoftwareThe client: Physical chemistry Group at a major Pharmaceutical company

By implementing

ProfileLynx into

their existing LC/MS

workflow, the chemists

reduced the amount

of time it takes

to perform these

tests from 51 to

just 20 hours.

56


T HE SOLUT ION

creating the proper tools for collecting sample information from

the database, formatting sample lists, and analyzing the data

generated consumed a great deal of analyst time.

By implementing Profilelynx™ – a specialized Application manager

for masslynx software that automates processing of physicochemical

property analyses – into their existing lc/ms workflow, chemists

reduced the amount of time it took to perform these tests from 51

to just 20 hours (figure 1). office time was reduced from 17 to 2.5

hours. Because of the improved reporting capabilities of Profilelynx,

the solubility evaluation now takes just 4 hours instead of 19.

BUSINESS BENEFIT

While the lc/ms sample analyses were efficient for the screen

solubility test, processing data and interpreting the results required

tedious and time-consuming data manipulation and calculation. By

introducing Profilelynx and other tools such as masslynx templates

into their workflow, the customer has saved about 30 hours on the

solubility screen for each set of 48 compounds. the time is now used

in the implementation of other tests.

Waters and Alliance are registered trademarks of Waters corporation. masslynx, Profilelynx, ZQ, and t he science of What’s Possible are trademarks of Waters corporation. All other trademarks are the property of their respective owners.


Figure 1. Chemists’ time distribution for a screen solubility test of 48 compounds using a manual process (top) versus ProfileLynx implementation (bottom).

0 10 20 30 40 50 60

2005ProfileLynx

2003ManualProcess

Time (hours)

Lab timeOffice timeEvaluation ID/PurityEvaluation SolubilityDatabase

As a result of the overall time savings, the group is able to

analyze more samples, as well as provide the critical information

necessary to make decisions about possible lead candidates

more quickly.

Because of the success of Profilelynx with this evaluation, the

software will be implemented with other tests within the Physical

chemistry group, including solid solubility, stability, and elogD.

WAT ERS SOLUT IONS FOR LEAD OPT IMIZAT ION

Waters system solutions for lead optimization provide an

automated, efficient selection process for determining compounds

that have potential to become successful therapeutics. these

solutions combine the strengths of Waters instruments,

chemistries, software, and customer support to assist discovery

labs in characterizing

compounds faster, easier, and more cost effectively.

Waters masslynx software and its Profilelynx Application manager

streamline data management for physicochemical property

profiling. masslynx interfaces with upstream data systems to

build sample lists used for data acquisition, while Profilelynx

automates the processing of chromatography-based data for

physicochemical property analysis.

57

BACKGROUND

the chemical surveillance Department (Veterinary sciences Division) of the Agri-food and

Biosciences institute (AfBi), a uK-based organization, tests food of animal origin for residues

of both banned substances and licensed veterinary drugs. the department is staffed by

approximately 60 scientists, who analyze approximately 35,000 samples annually, utilizing a variety

of analytical technologies including lc/ms/ms.

laboratory procedures are regularly audited by regulatory agencies and accreditation bodies

to ensure that the analytical methods are appropriately validated, demonstrating “fitness for

purpose”, and to ensure that the lab is carrying out its duties in accordance with accepted standards

set by the european union (eu). this includes maintaining accurate records, continuity of evidence,

and effective audit trails on all samples that enter the laboratory, including date received, date

tested, test method, and date released. failure to employ acceptable, well-defined and documented

methods or inadequate recordkeeping could result in loss of accreditation certification.

CHALLENGE

eu legislation demands that tandem mass spectrometric confirmatory methods monitor a

minimum of two “daughter” transition ions when confirming the presence of veterinary drug

residues in food of animal origin. recent advances in instrumentation have provided the ability

to monitor ever-larger numbers of transition products in much shorter periods of time.

one such technique employed by AfBi is the Waters® AcQuitY uPlc® system with the

Quattro Premier™ Xe tandem quadrupole mass spectrometer. the AcQuitY uPlc system

combines unique instrumentation and column chemistries to yield dramatically improved

resolution and speed. combined with the Quattro Premier Xe’s fast data acquisition rates and

ability to rapidly switch polarity – monitoring positively and negatively charged compounds in a

duty cycle of about 20 milliseconds – the system can generate more data in a shorter time scale.

laboratories involved in drug residue testing are continually working towards extending the

scope of multi-residue analytical techniques in an effort to reduce turnaround times and

improve cost effectiveness.

With eu regulations necessitating the acquisition, processing, and careful documentation of vast

quantities of data and resultant sample information, the food testing laboratory is faced with a

formidable information management challenge.

High-Throughput Food Safety Lab Automates QA Data Interpretation and Recordkeeping with NuGenesis SDMS And MassLynx Software Client: Agri-Food and Biosciences Institute

Through Waters integrated

Informatics solutions, AFBI

has successfully addressed

regulatory and technological

challenges and significantly

improved workflow and

data management.

58

T HE SOLUT ION

to analyze and manage the large quantities of data produced by

the Waters’ analytical system for food safety, AfBi selected an

integrated informatics solution consisting of Waters masslynx™

software for system control and data acquisition, paired with its

targetlynx™ Application manager, and the Waters nuGenesis®

scientific Data management system (sDms).

targetlynx automates data acquisition, processing, and reporting

for quantitative ms results and it incorporates a range of

confirmatory checks that identify samples that fall outside of

user-specified or regulatory thresholds. Given the sheer volume

of data generated, however, targetlynx reports can become very

large, creating problems associated with archival. With nuGenesis

sDms, both electronic reports and raw data are captured from any

instrument in the laboratory and are automatically stored and

indexed within a searchable database. Data can be easily retrieved

and shared among scientists throughout the organization.

BUSINESS BENEFIT

the Waters solution is providing a number of benefits to AfBi’s

laboratory operations including:

■■ ensuring regulatory compliance through automated targetlynx

calculations demonstrate that the relevant eu legislative criteria

are being fully met. Quantifying a single analytical batch often

requires thousands of calculations and comparisons, which can

all be fully automated using targetlynx.

■■ storing, indexing, and retrieving electronic data from a variety

of analytical instruments produced by multiple vendors. What

would previously have been thousands of pages of hard copy

reports have become fully searchable electronic documents.

■■ easily integrating scientific instruments with office software

and a lims database.

■■ Providing instant access to original experimental raw data

to any scientist connected to sDms, allowing conversion of

data to critical information.

■■ improving productivity through automation of QA data

interpretation and recordkeeping. this removes the need for

manual transcription of quality assurance data, since data

can be automatically extracted from captured reports.

■■ Automating the time-scheduled backup of critical instrumental

data files generated by any vendor’s instrument, or any

electronic file on any Pc.

■■ eliminating the need for generation and archival of thousands

of pages of hard copy reports, and the costs associated with

their production.

the AcQuitY uPlc system, combined with the Quattro Premier

Xe mass spectrometer has improved sample throughput and

is generating better quality data at a faster rate than ever

before. With Waters integrated informatics solutions, AfBi has

successfully addressed regulatory and technological challenges,

and significantly improved workflow and data management of

key information within its analytical food testing laboratory.


Waters, AcQuitY uPlc, and nuGenesis are registered trademarks of Waters corporation. Quattro Premier, targetlynx, masslynx, and the science of What’s Possible are trademarks of Waters corporation. All other trademarks are the property of their respective owners.


59

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Analysis Order Turnaround Times Reduced by 25% with Analytical Workflow ManagerClient: A Global Pharmaceutical company

BACKGROUND

A global pharmaceutical company develops drugs to treat a variety of disease conditions

including cancer, heart disease, and HiV. the company’s scientists rely on as many as 30

analytical testing labs that continually analyze thousands of chemical compounds used in or

generated by the drug development process.

structural chemical analysis assists researchers in the discovery of promising new products for

medical and industrial applications, while impurity profiling helps assure the quality of its products.

the research analytical laboratories operate as service centers that accept samples for analysis

from researchers and quality assurance technicians, routing the samples through tests in one or

more labs. the samples are then returned along with the analysis reports to the requesters. this

entire analysis process was paper based.

CHALLENGE

A flexible solution was required to minimize the manual paper-based processes between the research

chemists and the analytical laboratories. this required eliminating the paper-bound chemical analysis

processes at the customer‘s site and developing an efficient online workflow and system for sharing data.

“We wanted to enable the labs to combine their results into a data warehouse so we could provide

value-added research services. And we wanted the researchers to be able to readily benefit from the

analysis data that their colleagues had requested, which would lead to greater collaboration and fewer

duplicate analyses,” said the manager of the nuclear magnetic resonance laboratory.

T HE SOLUT ION

Waters® Analytical Workflow manager (AWm) and a site-wide deployment of the inspector Analytical

Data Viewer were installed to support researchers at the pharmaceutical company’s major site.

Analytical Workflow manager, an analytical laboratory collaborative workflow management

system with its integrated inspector software, met all of the customer’s technical requirements.

AWm was rolled out compliant-ready, helping the client meet the demands of 21 cfr Part 11

and applicable predicate rules where they apply to the documentation of lab workflow and data

procedures through valid digital records and signatures.

the initial rollout served three customer labs. Analytical Workflow manager is currently used

by more than 400 researchers and 40 lab technicians. in this deployment, AWm was scaled to

process up to 20,000 analysis orders per year and store 50,000 result sets.

“ This solution from IBM

and Waters Laboratory

Informatics lays the

foundation for a new era

of discovery based on

researcher empowerment

and global collaboration.”

LAB MANAGER,

GLOBAL PHARMACEUTICAL

COMPANY

62

As the focal point for all analysis performed within its three

participating labs, AWm integrates with several existing systems.

to minimize user training and promote user acceptance, an

interface was developed between the newly deployed systems and

the customer’s virtual electronic laboratory notebook workbench

software. the interface allows researchers to place orders for analysis

and access the results. the AWm receives order requests from the

electronic laboratory notebook workbench software system,

triggering the delivery of requests to the lab technicians.

Waters also integrated AWm with testing equipment in the

labs and with the customer’s classical lims environment. the

lims receives notification of incoming orders, tracks the tests

performed, and routes information to the customer’s sAP system

to efficiently generate billing for each order.

AWm can run on a broad range of servers, from a small intel-

based system to clustered linux, uniX or mainframe platforms.

this scalability and flexibility made the AWm’s Websphere

implementation technically and economically efficient; backed by

iBm support, it was also a low-risk option. the deployment included

iBm systems with Websphere Application server (Advanced

edition), Websphere studio Application Developer (formerly iBm

VisualAge for Java), and servers (iBm rs/6000 sP).

While AWm improves day-to-day productivity in the labs, it also

builds a database of analysis results, running on an iBm rs/6000

sP server. the database, which the customer estimates is growing

by three gigabytes every month, will serve as the basis for

collaboration among researchers.

BUSINESS BENEFIT

turnaround time for analysis orders was reduced by 25% in the

first year after rollout. the system promotes information sharing

and collaboration among researchers across the company. By

integrating analysis reporting with workflow and billing processes,

Analytical Workflow manager helps the customer improve

laboratory productivity while reducing errors.

“this breakthrough is immense. With the expertise of both iBm

and Waters laboratory informatics, we have transformed a dead

resource into a front-line research and workflow tool, while

opening up our analytical lab to the rest of the organization,” said

the lab manager.

the customer plans to implement AWm in five more analytical

labs, and extend the system to research and development

departments in other organizations within the company. the

customer believes that their strong relationship with Waters and

the support from iBm are providing strong impetus to proceed.

“this solution from iBm and Waters laboratory informatics lays

the foundation for a new era of discovery based on researcher

empowerment and global collaboration,” the manager said.

Waters is a registered trademark of Waters corporation. t he science of What’s Possible is a trademark of Waters corporation. All other trademarks are the property of their respective owners.




Waters, AcQuitY uPlc, uPc,2 uPlc, symmetry, Atlantis, Xterra, empower, Alliance, AcQuitY, and nuGenesis are registered trademarks of Waters corporation. Q-Dis/Qm, masslynx, Quattro Premier, targetlynx, Profilelynx, ZQ, openlynx, XBridge, and the science of What’s Possible are trademarks of Waters corporation. All other trademarks are the property of their respective owners.

nuGenesis sDms is covered under a formal Quality management system certified by lloyd’s register Quality Assurance.

nuGenesis eln and Analytical Workflow manager are covered under a formal Quality management system certified by the tÜV rheinland Group.

©2012-2013 Waters corporation. Produced in the u.s.A.may 2013 720002493en lB-PDf

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