Life Sciences Building Management Solutions Brochure
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Transcript of Life Sciences Building Management Solutions Brochure
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Life Sciences Building Management Solutions
Pipeline, timeline, deadlineImprove your bottom line
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Put your buildings to work for you
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Youre up against not only the competition, but regulatory demands for airtight proof of compliance. There are no excuses. There is no room for error.
In an environment like this one, you need
awless performance from every facet of your
organizationincluding your facilities. If your
building management system isnt doing its job,
your product pipeline is at risk. And so is your
bottom line.
At Schneider Electric, we specialize in creating
building management solutions that control and
monitor critical systems, capture key facility data,
and provide the proof of compliance you need
to keep everything moving at optimum speed.
The result is minimized risk, faster ROI, and a
competitive advantage in one of the most
unforgiving industries in the business world.
Think about it. Are your buildings doing
their share?
Keep your product pipeline owingWell show you how
Benet from our experience in ways you can measure Schneider Electric is an industry leader in helping life sciences companies get the most from their facilities. From initial
design through installation and qualication, to ongoing operations and maintenance, Schneider Electric is a long-term partner you
can trust. Our global life sciences experience delivers measurable results that maximize capital procurement and operating efciencies
while running your facility with minimal regulatory and business risks. Why not put our experience to work for you?
The Genzyme Center
earned a Platinum
certication, the highest
rating issued by the U.S.
Green Building Council,
under its LEED (Leader-
ship in Energy and Envi-
ronmental Design) Green
Building Rating System.
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Since product quality and the safekeeping of
research data are the lifeblood of a life sciences
company, the last critical link in the facility delivery
chain is the turnover of a properly qualied BMS.
The need for more powerful, integrated and
secure building management solutions is tied to
evolving regulatory compliance and increasing
business challenges.
Schneider Electric helps life sciences companies
worldwide comply with regulations that apply to
the types of products they manufacture or
process. Hundreds of facilities managed by
Schneider Electric systems have passed the
scrutiny of the US Food & Drug Administration
(FDA), European Medicines Agency, Health
Canada, and more. Schneider Electrics life
sciences customerswho include pharmaceutical,
biotechnology and medical devices companies
along with blood, organ, and tissue-handling
institutionsuse Schneider Electric systems to
provide paperless proof-of-compliance with all
predicate rules.
A BMS directly impacts the timely delivery and compliant operations of a life sciences facility.
A BMS you can depend onIts critical to your success
The World Health Organization (WHO) emphasizes
the factors that contribute to product quality in a
life sciences manufacturing operation. A BMS
has critical control and monitoring responsibilities
in the areas of Environmental and Personnel
management. It also affects and is impacted
by Procedures, Premises, Equipment, and
Validated Processes.
How a Schneider Electric BMS contributes to life sciences product quality
Escalating consequences of non-compliance: 483s (Notices of Inspectional Findings), Warning Letters, Substantial
Fines, New Product Introduction Delays, Product Seizures, Plant Shutdowns, Operating License Revocations. Schneider
Electric helps you comply with the requirements of regulatory agencies such as: FDA (USA), EMEA (Europe), MHRA (UK), Health
Canada, TGA (Australia), PMSB (Japan), CDSCO (India), SFDA (China).
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Accelerate your return on investment
The process from discovery to approval of a new drug or device often takes
more than 10 years at a cost that can exceed $1 billion US. Further, between
clinical trials and promotion lies a critical phase in the life cycle of a new drug
or devicethe phase in which a building management systems value can help
accelerate revenue realization or bring less than optimal return on investment.
Schneider Electric focuses on delivering properly qualied life sciences
facilities built to specication, within budget and on schedule. This results in
an on-time facility turnover capable of capturing billions of dollars in additional
market opportunity.
The gap between the lines of a problem facility scenario and a Schneider
Electric facility scenario in the diagram below shows the dramatic difference
in return on investment if a facility experiences a delay in turnover. Schneider
Electrics involvement early onfrom the pilot plant stage through the
complete life cyclewill accelerate your products time to market and assure
consistent, high levels of environmental quality that secure long-term returns
on your facility investment.
Schneider Electric has passed stringent audits by customers and prospects
worldwide as part of their due diligence processes for vendor selection and
retention. Our history and success with key life sciences customers globally
has given us the expertise to evolve with you. Trust in your BMS supplier is vital
to your operation and your companys ability to reduce risk and optimize facility
value. Schneider Electric brings engineering experience, as well as exible,
scalable architectures that grow and adapt over the lifetime of your facility.
Typical drug life cycle/return on investment
R&D
$0.00
Time to Market
Approval
Rev
enue
Pilot Plant
Clinical Trials
Acceleration of ROI
Promotion Competition
Schn
eider
Electric Scenario
Proble
m Scenario
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Take the most direct route from design to qualicationWell lead you down the right path
Applying Good Practices Schneider Electric has experience supporting regulations and applying
Good Practices (GxPs) in the many areas under BMS control. For example,
applying intelligent risk assessment techniques limits qualication efforts
to areas of specic regulatory interest. This ensures on-time delivery of
value-optimized and properly validated facilities.
Applicable regulations and guidance documents:
Title 21 Code of Federal Regulations (CFR) sParts 11, 58, 210, 211, 600, 610, 820
GxPs, GAMP5, Q7As
Even in an environment as complex as yours, a sophisticated BMS solution can nd efciencies in controlling and monitoring critical systems, capturing key data, and providing the proof of compliance your facility demands.
Our clients include: Amgen Inc.; AstraZeneca; B. Braun Medical Inc.; Bayer AG; Biogen Idec; Boston Scientic Corporation;
Bristol-Myers Squibb; Canadian Blood Services; Cipla Ltd.; Eli Lilly and Company; F. Hoffmann-La Roche Ltd.; Genzyme
Corporation; GlaxoSmithKline plc.; Hma-Qubec; Johnson & Johnson Services, Inc.; Merck & Co., Inc.; Novartis AG; Novo Nordisk
A/S; Pzer Inc.; Sano-aventis; STERIS Corporation; The American National Red Cross.
Corporate Ofces
Central Utilities
Animal Facilities
Research & Discovery
Building Management System
Warehousing & Distribution
GxP Non GxP Mixed
Clinical Supply
Manufacturing Operations
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Who is in the laboratory right now?
Why was the pressure setpoint changed?
When was the humidity sensor last calibrated?
What is the Mean Kinetic Temperature (MKT) of the warehouse?
Where was the security guard at 3:00 am?
Total Environment ManagementTotal Environment Management (TEM) is
Schneider Electrics process to monitor and
control all the critical events and parameters
that can change the desired environmental state.
This approach helps life sciences companies
reduce regulatory and business risks while
optimizing facility value.
Maximize control, minimize riskA TEM solution from Schneider Electric allows
you to know and record all critical facility issues.
All important events and parameters can be
captured along with authenticated operator IDs
and explanations for actions taken. Together,
this information provides complete event
traceability and user accountability, along with
offering a panoramic view of whats happening
in your facility. TEM delivers precise environmental
and security controls with the ability to answer
the questions of what happened when, why,
where, and who was involved.
Critical facility issues have no place to hideManage your total environment
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We have worked extensively with life sciences
industry organizations like the BMS special
interest group of the Good Automated
Manufacturing Practice (GAMP) Forum to determine
best industry practices. The GAMP Forum is part
of the International Society for Pharmaceutical
Engineering (ISPE). The diagram below depicts the
functional requirements of a BMS in a regulated
facility. One way to reduce BMS validation efforts
is to partition the fulllment of system requirements
with the use of a fully qualied, independent system
to monitor, log, and report.
Schneider Electric systems can support this
approach, but a single BMS, designed so that the
direct impact subsystems are identied, partitioned,
and validated, fullls the same requirements. The
result is tighter control with the same degree of
monitoring integrity. This approach yields cost-
efciencies from initial capital procurement through
the operational life of the system.
You have to monitor what you controlWhy not use the same system for both functions?
Control Parameter Management
Control & Processing Monitoring
Measurement/Outputs
Calibration Management
Reporting
Data Logging Alarm & Event Logging
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Hit your product impact targetWell improve your aim
Exacting criteria are applied to lter, group, and
correlate information. This ensures that evidence
required for proof of regulatory compliance is not
lost within all the data a BMS system collects.
Other data are of great business and operational
interest to managers; to regulators, they are
superuous and distract from their target
of interest.
Schneider Electrics Project Delivery ApproachConsistent use of eld- and time-proven
methodologies, along with rigorous ISO 9001
quality controls, combined with skilled project and
account management, contribute to the superior
results you can expect from Schneider
Electric. Our extensive country, branch, and part-
ner organizations draw on an international pool of
highly trained and experienced project managers,
engineers, and technicians to deploy our global
expertise. Well established relationships with
architecture, engineering, and construction
management rms prevalent in life sciences
strengthen our delivery capability.
Schneider Electric Validation ToolkitSchneider Electric Validation ToolkitTM is a full
set of guidelines and customizable document
templates designed to support validation of
Schneider Electric systems in regulated industry
applications. It is based on industry standard
methodologies set forth in GAMP5Guide for
Validation of Automated Systems. The Validation
Toolkit is the product of decades of BMS
validation experience. Hundreds of facilities have
been validated and passed regulatory inspections
based upon the practices it supports and classes
of products it is used to deliver.
Your BMS plays an important role across the product impact spectrum and Schneider Electric systems are designed to monitor, log, archive, and report information on a highly granular basis.
The Schneider Electric Validation Toolkit Contains: Sample Applications, Project Planning Guide, Project Quality Assurance Manual,
User Requirements Specication (URS), Functional Specication (FS), Detailed Design Specication (DDS), Factory Acceptance Test
(FAT), Site Acceptance Test (SAT), Project Turnover Package, Project Validation Plan, Installation Qualication (IQ), Operational Qualication (OQ),
Performance Qualication (PQ), Summary Qualication Report, Traceability Matrix, 21 CFR Part 11 Assessment.
Examples:
Regulated space temperatures, pressures, airows, setpoint changes, access records
Air handler alarms, server room environment
Equipment run- times, lter differential pressures
Ofce space temperatures, parking lot barrier position
All Facility Events & Paramet
ersBusiness Valuab
le
Business Critical
Regulatory Requirements
Impo
rtan
ce
From initial system specications through qualication of the installed system, the Schneider Electric Validation Toolkit provides comprehensive support to the entire BMS validation process.
Implementation
System Design Specications
User Requirements
PQ Test Plan
OQ Test Plan
IQ Test Plan
Performance Qualication
Functional Design
Detailed Design
Installation Qualication
Operational Qualication
System Test Specications
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GxP Areas
Facility Management Workstation
Access Control & Monitoring
Air Handling Unit
Terminal Unit
VAV Controller
Field Controller
BiometricSensors
Digital Video Recording
FumeHoods
IntrusionMonitoring
ParticulateMonitoring
Non-GxP Areas
SQL Server
Lighting
Access Control & Monitoring
Central Plant
Terminal Unit
Touch ScreenDisplay
VAV Controller
Field Controller
Fire Systems
Intrusion Monitoring
Power Monitoring
Secure Server Room
Door Module
Supervisory Controller
Door Module
Supervisory Controller
Secured Resources
Facility Management Workstation
Facility Management Workstation
Extensive security features in Schneider Electric
systems can be congured to allow or restrict
individual or group access to system functions,
equipment, and facility areas on a selective basis.
This approach allows a validated subsystem to be
effectively locked-down and does not subject
other subsystems to the same strict quality
assurance requirements. Operations, maintenance,
calibration, and documentation efforts for non-
regulated areas can be dramatically reduced. This
risk-based approach yields major cost savings
and assures that secure logging, alarm monitoring
and control of critical parameters is achieved. The Schneider Electric system plays a critical role in ensuring regulatory compliance for our facilities.
Luc Pelletier, Facility Director, Hma-Qubec
Theyre called critical subsystems for a reasonBased on a detailed product impact assessment, Schneider Electric systems can be partitioned to isolate critical control, monitoring, alarming, and reporting subsystems from the overall BMS architecture.
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Clean Room ExpertiseManagement of a clean room serves as a prime
example of the advantages of an integrated
control system because clean rooms require tight
integration between air-handling and access
management systems. An integrated system
facilitates straightforward and cost-effective
engineering and reduces validation costs and risks.
Due to the extensive range of open standards
supported by Schneider Electric systems,
integration of complementary specialist devices
and subsystems like particulate monitors and
fume hood controls is easily realized.
Precision EnvironmentsSchneider Electric has broad experience and a
well established track record of building clean
room projects with our Precision Environments (PE)
group. This team of specialists from Schneider
Electric offers full clean room turn-key services
including design, installation, commissioning, and
validation. All system components such as oors,
walls, and ceilings together with security, electrical,
lighting, and control systems are integrated to
deliver a performance guaranteed environment.
Lower cost. Lower risk. Guaranteed performance.Now thats clean
Schneider Electric lets me know theres a problem immediately so I can take the appropriate action quickly. In a nutshell, I can run my facility from anywhere!
Tom Martin, Facility Manager, Amgen
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Whats at risk if your data isnt secure? Everything
TAC Vista for Regulated IndustriesSchneider Electric answered the call from our life sciences customers for
support of 21 CFR Part 11. We introduced enhancements like the use of a
Microsoft SQL database to securely store all long-term trend logs and events.
Each record in the database is individually protected from alteration by a SHA1
digital signature encryption algorithm that TAC Vista uses to automatically
generate an alarm if a record is modied. For any or all events, TAC Vista can
be congured so that operators must conrm their unique user name and
password combination that serves as an authenticating electronic signature
sign-off for the action. Further, information about the cause of an event,
any action taken as a result, and an explanatory comment can be entered.
This data is stored in the SQL database and can be accessed to generate
comprehensive audit trails and reports.
Andover Continuum CFR Compliance PackCFR Compliance Pack enhances Schneider Electrics Andover Continuum
system to provide technical controls and features that support the electronic
records and signature requirements of the FDAs 21 CFR Part 11 regulation.
The rich standard feature-set of Continuum provides functions to support
regulatory compliance including:
Comprehensive password managements
Enforced operator explanation for all alarm acknowledgementss
Alarm generation for invalid and disabled user login attemptss
Secure data point and event loggings
Powerful report generations
Detailed audit trailss
The CFR Compliance Pack adds to these capabilities with powerful archiving
and reporting tools allowing you to create PDF les protected with digital
signatures. For all system changes, operators can be forced to provide
electronic signatures and an explanation of their actions.
Typical operator dialog screens
for a critical alarm condition.
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Capital Procurement and Operating EfciencyIntegrated BMS solutions yield cost savings and operational benets. A recent
case study identied cost savings of over 24% for an integrated BMS solution
compared to a more traditional separate systems approach. Due to its
highly distributed nature, the BMS is pervasive throughout a facility and
offers a natural integration platform for all building systems. In effect, the
BMS acts as the central nervous system of a facility.
Schneider Electrics leadership in open systems technologies supports the
integration of a diverse range of disparate devices and subsystems into
unied, highly functional solutions. Included among the open technologies
we champion and support are BACnet, LonWorks, Modbus TCP, OPC
and XML. Progressive life sciences companies use their BMS infrastructure
to integrate electrical, utilities, process, access control, and re and life safety
systems together. The BMS has the communications bandwidth, comput-
ing power and database capacity to provide a common interface from these
subsystems for centralized engineering and enterprise level functions such as
maintenance management, Manufacturing Execution Systems (MES) and Hu-
man Resources databases.
An integrated BMS is the centralnervous system of your facilityA smart facility is a smooth running and protable facility
Energy and Building Management Solutions for Life Sciences
Green: Make renewable energy sources reliable and cost effective
Reliable: Prevent power outages & quality variances
Safe: Transform and distribute power safely
Make Energy Efcient & Productive:
Measure, control, automate, and diagnose processes and systems
Make all utilities more efcient
Interoperable and open to third-party systems Eco truxureSimple software integration
Renewable energies
Energy monitoring & control
Security
HVAC control
Motor control
Critical power & cooling
Lighting control
Access control
Electrical distribution
The U.S. pharmaceutical industry consumes OZ[]abPWZZW]\CA2in energy annually. How is that affecting your bottom line? Schneider Electric can help you position yourself in the Dow Jones Sustainability Index signicantly improving your image and your nancial performance by focusing on energy efciency. So, what is the rst step? Set energy savings goals and measure and track energy performance for all operations across your business.
How? Take that rst step with a partner Schneider Electric, the global specialist in energy management. As an industry leader, Schneider Electric is helping top tier life sciences corporations prioritize and realize sustainability goals.
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The Strength of Schneider Electric for Life SciencesSchneider Electric offers compatibility and
synergy through fully integrated building man-
agement systems. We combine industry-leading
electrical and power products with building
management and security solutions. The result is a
one-stop resource for controlling multiple build-
ing systems, helping to manage regulatory and
business risks while optimizing life sciences facility
value.
About Schneider ElectricAs a global specialist in energy management with
operations in more than 100 countries, Schneider
Electric offers integrated solutions across multiple
market segments, including leadership positions
in energy and infrastructure, industrial processes,
building automation, and data centers/networks,
as well as a broad presence in residential
applications. Focused on making energy safe,
reliable, and efcient, the companys 114,000
employees achieved sales of more than 18.3 billion
euros in 2008 (27 billion USD), through an active
commitment to help individuals and organizations
Make the most of their energy.
www.schneider-electric.com/buildings
" Schneider Electric employees available to help you countries with Schneider Electric locations ready to serve you
Put our experience to work for youYoull be glad you did
Schneider Electrics high technology approach provides us with the best of whats out there. And the company continues to respond to our needs.
Sabi Bivas , Senior Systems Associate, Merck & Co.
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This document has beenprinted on recycled paper
Schneider Electric
One High Street North Andover, MA 01845 USA Phone: +1 978 975 9600 Fax: +1 978 975 9698 www.schneider-electric.com/buildings