Webinar Presentation – The Integrated Sample Lifecycle...
Transcript of Webinar Presentation – The Integrated Sample Lifecycle...
Pharma&Biotech
Lonza Wayne Inc., Wayne, PA 19087 / February 2014© Lonza
The Integrated Sample Lifecycle: Automating Devices,
Media and Monitoring Systems with MODA™
Webinar: 11 February 2014
Speaker: Michael Goetter
Director of Lonza Bioscience Informatics
Pharma&Biotech
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Today’s Presenter
Michael Goetter, Director of Informatics
Lonza Pharma&Biotech – Bioscience Solutions
10+ years IT Consulting (IT strategy, custom software
development and systems integration)
10 years Quality Systems and Informatics (quality
control and biopharmaceutical quality systems)
Venture capital due diligence and consulting for early
stage IT ventures
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Forward Looking Statements
Certain matters discussed in this presentation may constitute forward-looking statements.
These statements are based on current expectations and estimates of Lonza Group Ltd,
although Lonza Group Ltd can give no assurance that these expectations and estimates
will be achieved. Investors are cautioned that all forward-looking statements involve risks
and
Uncertainty and are qualified in their entirety. The actual results may differ materially in
the future from the forward-looking statements included in this presentation due to various
factors. Furthermore, except as otherwise required by law, Lonza Group Ltd disclaims any
intention or obligation to update the statements contained in this presentation.
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Agenda
Lonza and Bioscience Informatics Overview
Common compliance and clerical issues
Why “paperless lab” is not enough
How MODA™ manages complete sample lifecycle information
Making the right integration choices with limited time and budget
Compliance, time-saving and information intelligence benefits
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Lonza Overview
Trusted supplier to the pharmaceutical, biotech and
specialty ingredients markets
Founded in 1897 with headquarters now in Basel, Switzerland
Sales of about CHF 3.6 billion in 2013
Global operations:
Located in more than 40 major sites
Employs approximately 10,000 people
Global leader in microbial control and custom manufacturing:
Hygiene
Water treatment
Active pharmaceutical ingredients, both chemical and biological
Cell therapy
Leading positions in product market niches:
Endotoxin detection
Cell-based research products
Nutrition ingredients
Performance intermediates
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WinKQCL™ 5 Software
WinKQCL™ 5: Enterprise-class Endotoxin Analysis Software
Best-of-breed data management platform for endotoxin testing and analysis
Support for many industry-leading readers
Comprehensive ad hoc test analytics and reporting suite
Enterprise Support for multi-site management and collaboration over a global
network
Integration to third party systems (e.g. MODA™, LIMS, LIS)
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MODA-EM™ – QC Microbiology Software
More Science. Less Paper.
Purpose-built QC Microbiology platform
Quickly move from paper-intensive QC
monitoring/analysis
Measurable gains in operational efficiency,
improved quality, reduced costs
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QC Micro Compliance and Deviation Challenges
Data Entry and Data Review
Manual, paper based process using controlled paper
Long cycle time for data review
Multi-step, redundant data approval process via LIMS
Approve Sample, Test and Record
Data Reconciliation
Data is generated and maintained in multiple locations, which makes
mining that information for reports and investigations a difficult task
Manual reconciliation of samples to paperwork requires multiple steps
Trend Report Generation – Extensive data checking required to
assure all samples are included in quarterly reports
Compliance to SOP’s not enforced: calibration, media expiration,
incubation times, etc.
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Laboratory Workflow
Typical Sample Lifecycle
Process Step is Non-Value Add
Process Step is Non-Value Add but Required
Process Step is Value Add
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QC Micro Integration Points… And Where
They End Up…
Laboratory Management Sample Records Spreadsheets
Disparate Data Points Air, Surface, Water Media Equipment Personnel
“Islands” of Information
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LIMS and ELN Gaps – Paperless for QC Micro?
Typically product and chemistry-centric testing model
Trending and limits limited to batch and product
Integration focused on batch imports of lab devices
No simple answer to the variability of personnel monitoring and
organism identification/trending
LIMS and often ELN data entry starts in the lab
High QC micro sample volume requires automation in the production
area (aseptic typically ranges from 105 to 106 samples per year)
High QC Micro sample volume requires workflow models which
process multiple sample and sample types at one time
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QC Micro Requirements in the Sample Lifecycle
Plan
Capture and confirm samples were taken where and when they are
scheduled
Prevent missed samples
Track the product and batch number being produced during monitoring
Collect
Track samples from point of collection to lab
Confirm use of correct media, within expiry, and track lot number
Collect information about viable and particulate air quality and other
environmental indicators during operation
Track the personnel in the room and their microbial status
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QC Micro Requirements in the Sample Lifecycle
Process
Confirm sample receipt in the lab
Collect data about and from equipment used in testing
Track sample through lab processing and results
Confirm equipment and media used is in conformance with SOP (ex.- incubation
times)
Capture results quickly and accurately
Evaluate and alert for critical events (ex.- over alert and action limits, critical
organisms)
Review and Analyze
Rule out invalid and false positive results: review details of every step in the sample
lifecycle and what was used in the process
Report and trend details quickly and accurately by location, classification, personnel,
organisms, product, etc.
Conduct investigations and excursions quickly, accurately and with access to
comprehensive information
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Why Pursue Sample Lifecycle Integration?
Reduce human intervention
Reduce human error
Prove accuracy of data
Prove compliance with SOPs
Improve availability/comprehensiveness of data
Eliminate data aggregation and manual analysis
Eliminate non-value added sample lifecycle steps/labor
Reduce time between decision to take a sample and decision to
act on the data!!
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Integrated Sample Lifecycle – The Outcome
Elimination of
17 NVA’s.
Prepare Sample
Bottles, Media
and Equipment
Travel to Sample
Location
Sample EM /
WaterDeliver to Lab
Water / EMRead Plates
Test BB
Test CON / TOC /
LAL / COL / EP
Incubate PlatesRead Plates
Excursion
YES/NO
Approve Data
Perform
Investigation
EM
WATER
NO
YES
Incubate Plates
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MODA-EM™ –
An Integrated Solution for QC Micro
Improved Compliance Increased Productivity Expedited Decision Making
Paperless, Automated Sample Lifecycle
MODA™ Solution Components
Mobile Data Acquisition
Flexible Workflow
Integration
On-Demand Analytics
Systems (ERP, LIMS, CAPA)
Devices
Media
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Plan and Collect – Mobile Data Acquisition
Mobile computing platform for field data capture in
clean room areas:
Offline sampling and data synchronization
Stainless steel cart
Ergonomic tablet PC
Docking station
Thermal label printer
Barcode scanner gun
Proximity reader for
RF badges
Space for equipment
Space for growth media
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Plan and Collect –
MODA™ Integration Capabilities
Batch or ERP system submits product and lot data and triggers monitoring plan
Barcoded locations and ports confirm correct routine is followed
Automatic sample submission upon collection – mobile platform submits sample data
when sample is taken
SOPs can be viewed electronically from document management systems
Media qualification check – pre-barcoded media automatically confirms correct type, lot,
expiration date and growth promotion status
Portable particle counters are run from MODA™ mobile platform, collect particulate
results, and send data directly to MODA™
Personnel IDs are scanned and matched for glove and gown monitoring
Continuous monitoring systems send data to MODA™ about particulates, temperature,
humidity, etc.
Online TOC and Conductivity meters capture results at water port
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Process –
MODA™ Integration Capabilities
Sample tracking – pre-barcoded media or barcode labels link the physical sample to
the electronic record and next step in testing process
Group barcodes are created and scanned to track similar samples quickly and
accurately
Testing consumables and equipment are scanned, tracked and qualified for use, in
accordance with SOP
Incubators are scanned, confirming temperature placement and time-tracking
Sample labels or pre-barcoded media are scanned, presenting correct results entry,
checking limits and automatically entering negative results
Results from LAL Software (ex.- WinKQCL™), TOC and Conductivity meters are
imported directly into MODA and matched with samples
Results from Organism ID and Rapid Micro systems provide results and complete
organism information directly to MODA™, matching assay with samples
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Review and Analyze
Track and trend by location, room, sampling site, person, organism,
product batch/lot and any combination
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Review and Analyze
Visualization – Trend and correlate environment, process (i.e. water
loop), across multiple tests over specified dates
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Review and Analyze –
MODA™ Integration Results
Approved EM and Water Results, deviations are sent to LIMS or ERP system submits
product and lot data and triggers monitoring plan
Organism identifications and supporting data are trended with results
Personnel are trended and scored for aseptic qualification
Notifications provide timely alerts for critical events and adverse trends
Continuous monitoring systems send data to MODA™ about particulates,
temperature, humidity, etc.
Data marts and flexible integration methods aggregate data from integrated media,
devices, and systems to apply detailed analytics for all aspects of QC Micro Monitoring
(ex.- CMS)
Dynamic, Visual Maps show results and allow drill-down into hotspots for Rooms and
Water Loops for investigations, CAPA and root cause analysis
Formal Reports and Ad Hoc Trends are generated quickly, flexibly and accurately
across all MODA™ data for excursion support and routine reporting
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Integration Methods
Integration Method Description Typical Purpose
Web Service API A service-oriented
architecture API
consisting of a series of
standard web service
method calls
• LIMS or ERP systems for batch scheduling,
batch reporting, product/raw materials tests
and consumables mgmt.
• Calibration Mgmt. Systems for equip.
maintenance
• Continuous Monitoring Systems for
particulate results per batch
File Import/Export Import or export data
to/from MODA from csv
or xml files (Excel
supported)
• Import of sample information from
spreadsheets
• Import of initial configuration information
• Import of TOC and LAL results
• Export of samples/results to Excel
• Export of samples/results to LIMS
(scheduled import)
• Export of samples/results to SPC tools
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Integration Methods
Integration Method Description Typical Purpose
Direct to Database Reporting views and
stored procedures
which can be called
directly from the
database (with
permissions)
• Access to enterprise reporting tools (ex.-
SAP Business Objects)
• LIMS integration (transactional)
• SPC tool integration (views)
Device Framework RS-232 and modbus
supported interfaces
with configurable data
mapping
• Particle counters
• Organism identification systems
Workflow API Stored procedure
framework for adding
event-based workflow
options and redirection
during the sample
lifecycle
• Complex test methods
• Special or external system notifications
• Special compliance steps
• Other system integration (ex.- Trackwise)
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MODA™ Integration Examples
SPC tool
accesses
reporting views
for analysis Data
bas
e
LIMS/ERP
Pushes batch
number and
schedule
CMS sends
batch
particulate
results for
processing
We
b S
erv
ice
AP
I
Workflow API
manages
complex test
methods
User starts
particle counter
and acquires
readings Devic
e
Fra
me
wo
rk
User imports
sample data
from Excel
User imports
results from
LAL/TOC
devices
File
Im
po
rt/
Ex
po
rt
LIMS/ERP
calls batch:
• Summary
• Deviations
• All results
Plan Collect Process Review & Analyze
User exports
results from
Analyze in
Office XML
(Excel)
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Evaluating Your Integration Options
Cost Considerations Benefit Measurements
• Initial installation and development
• Validation
• Data migration
• Ongoing support
• Additional equipment/ consumable costs
• Compliance/regulatory qualification
• Net time impact (new vs. old process)
• Proof of SOP conformance
• Error-rates of results
• Number of process deviations
• Labor hours saved
• Volume of samples affected
• Criticality of process/test
• Investigation/excursion time
• Quality and speed of reporting and CAPA
Like any business decision, choosing what parts of the sample lifecycle to
integrate and when is a function of cost vs. benefit measured in:
Time, Compliance and Money
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Measuring the Benefits –
FTE Analysis Example
Projected Year 1
Headcount
Impact = x FTE’s
Overall Savings of
2x FTE’s
to double sampling
volume.
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Conclusions
QC Micro organizations face unique challenges managing data
throughout the sample lifecycle that are distinct and different from
product testing
Many traditional “paperless lab” solutions continue to focus on
chemistry and/or limit their scope to the workflow within the lab
Truly “Paperless” for QC Micro requires looking beyond the lab for
integration of many data points throughout the sample lifecycle
MODA™ provides a purpose-built platform that integrates sample
information with devices, systems, people and consumables to provide
a comprehensive view of QC Micro
An effective integration approach focuses on optimizing the sample
lifecycle with measurable time, cost and compliance benefits
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Upcoming MODA™ Product Releases
MODA-EM™ Version 3.2 – Coming Soon!
New calendar and scheduling interface and features
New reporting and trending features
Improved device interfaces for non-viables, LAL and TOC
Many new out-of-box device integrations- Organism ID, online TOC,
conductivity meters, etc.
MODA-EM™ Version 4.0 – In Development
Comprehensive, configurable workflow engine
New features for QC and bio-processing production EBR
Major new analytics and trending features
Web browser and tablet user interface
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Questions & Answers
To submit a question, please use the “Questions” feature located
in your control panel, which you can access by clicking on the
orange arrow on the right hand side of your screen.
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Wrap-up: More Information
Mike Goetter
Director of Informatics
Email: [email protected]
Learn more about MODA™:
www.lonza.com/moda
Or via email: [email protected]