Pipeline, timeline,

deadline
Improve your bottom line

Life Sciences
Building Management Solutions

Put your
buildings to
work for you

Keep your product

pipeline owing
Well show you how
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?

The Genzyme Center

earned a Platinum
certication, the highest
rating issued by the U.S.
Green Building Council,
under its LEED (Leadership in Energy and Environmental Design) Green
Building Rating System.

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?

A BMS you can depend on

Its critical to your success
A BMS directly impacts the timely delivery and compliant operations of a life sciences facility.
Since product quality and the safekeeping of

The World Health Organization (WHO) emphasizes

research data are the lifeblood of a life sciences

the factors that contribute to product quality in a

company, the last critical link in the facility delivery

life sciences manufacturing operation. A BMS

chain is the turnover of a properly qualied BMS.

has critical control and monitoring responsibilities

The need for more powerful, integrated and

in the areas of Environmental and Personnel

secure building management solutions is tied to

management. It also affects and is impacted

evolving regulatory compliance and increasing

by Procedures, Premises, Equipment, and

business challenges.

Validated Processes.

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.

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).

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,

Revenue

Sc
h

scalable architectures that grow and adapt over the lifetime of your facility.

Acceleration
of ROI

ne

e
id

le
rE

ob
Pr

c tr

S
lem

ic Scenario

cenario

$0.00

R&D

Pilot
Plant

Approval
Promotion
Clinical
Trials

Time to Market
Typical drug life cycle/return on investment

Competition

Take the most direct route from

design to qualication
Well lead you down the right path
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.

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:
sTitle 21 Code of Federal Regulations (CFR)
Parts 11, 58, 210, 211, 600, 610, 820
sGxPs, GAMP5, Q7A

Corporate Ofces

Manufacturing
Operations

Central Utilities

Clinical Supply

Animal Facilities

Warehousing
& Distribution

Research
& Discovery

Building Management System

GxP

Non GxP

Mixed

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.

Critical facility issues have no

place to hide
Manage your total environment
Total Environment Management

Who is in the
laboratory right now?

Total Environment Management (TEM) is

Where was the security

guard at 3:00 am?

Schneider Electrics process to monitor and

control all the critical events and parameters
that can change the desired environmental state.

Why was the pressure

setpoint changed?

This approach helps life sciences companies

reduce regulatory and business risks while
optimizing facility value.

When was the humidity

sensor last calibrated?

Maximize control, minimize risk

A 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.

What is the Mean

Kinetic Temperature
(MKT) of the warehouse?

You have to monitor what you control

Why not use the same system for both functions?
We have worked extensively with life sciences

Schneider Electric systems can support this

industry organizations like the BMS special

approach, but a single BMS, designed so that the

interest group of the Good Automated

direct impact subsystems are identied, partitioned,

Manufacturing Practice (GAMP) Forum to determine

and validated, fullls the same requirements. The

best industry practices. The GAMP Forum is part

result is tighter control with the same degree of

of the International Society for Pharmaceutical

monitoring integrity. This approach yields cost-

Engineering (ISPE). The diagram below depicts the

efciencies from initial capital procurement through

functional requirements of a BMS in a regulated

the operational life of the system.

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.

Reporting

Control Parameter
Management

Calibration
Management

Data Logging

Control & Processing

Alarm & Event

Logging

Monitoring

Measurement/Outputs

Hit your product impact target

Well improve your aim
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.

correlate information. This ensures that evidence

Examples:

required for proof of regulatory compliance is not

Regulated space
temperatures,
pressures, airows,
setpoint changes,
access records

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 Approach

Bu

Consistent use of eld- and time-proven

methodologies, along with rigorous ISO 9001
quality controls, combined with skilled project and

Air handler
alarms, server
room environment

Regulatory
Requirements

Al

s in e

s s Cri ti

ca

Equipment runtimes, lter

differential pressures

Bu
le
sines
s Valuab
rs
lF
aci
e te
l i ty
m
Events & Para

Importance

Exacting criteria are applied to lter, group, and

Ofce space
temperatures, parking
lot barrier position

account management, contribute to the superior

results you can expect from Schneider
Electric. Our extensive country, branch, and partner 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

System Design
Specications

System Test
Specications

architecture, engineering, and construction

management rms prevalent in life sciences

PQ Test Plan

User
Requirements

Performance
Qualication

strengthen our delivery capability.

Schneider Electric Validation Toolkit

Schneider Electric Validation ToolkitTM is a full

OQ Test Plan

Functional
Design

set of guidelines and customizable document

templates designed to support validation of
Schneider Electric systems in regulated industry

Detailed
Design

IQ Test
Plan

Operational
Qualication

Installation
Qualication

applications. It is based on industry standard

methodologies set forth in GAMP5Guide for

Implementation

Validation of Automated Systems. The Validation

Toolkit is the product of decades of BMS

From initial system specications through qualication of the installed system, the Schneider
Electric Validation Toolkit provides comprehensive support to the entire BMS validation process.

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.

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.

Theyre called critical subsystems

for a reason
Based 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.
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 nonregulated 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.

SQL Server

Luc Pelletier,
Facility Director,
Hma-Qubec
Secure
Server
Room

GxP Areas

Facility
Management
Workstation

Non-GxP Areas

Facility
Management
Workstation

Facility
Management
Workstation

Digital Video
Recording
Door
Module

Supervisory
Controller

Access
Control &
Monitoring

Door
Module
Biometric
Sensors

Air
Handling
Field
Unit
Controller

Fume
Hoods

Supervisory
Controller

Access
Control &
Monitoring

Central
Plant

Lighting

Field
Controller

Intrusion
Monitoring

Intrusion
Monitoring
Terminal
Unit

VAV
Controller

Terminal
Unit

VAV
Controller
Power
Monitoring

Particulate
Monitoring

Secured Resources

Fire
Systems

Touch Screen
Display

Lower cost. Lower risk.

Guaranteed performance.
Now thats clean
Clean Room Expertise

validation. All system components such as oors,

Management of a clean room serves as a prime

walls, and ceilings together with security, electrical,

example of the advantages of an integrated

lighting, and control systems are integrated to

control system because clean rooms require tight

deliver a performance guaranteed environment.

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

7A="$""AbO\RO`Ra

and subsystems like particulate monitors and

fume hood controls is easily realized.

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1ZOaaSabV`]cUV&

Precision Environments

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bV`]cUV"

Schneider 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

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

Whats at risk if your data isnt secure?

Everything
TAC Vista for Regulated Industries
Schneider 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 Pack

CFR 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:
sComprehensive password management
sEnforced operator explanation for all alarm acknowledgements
sAlarm generation for invalid and disabled user login attempts
sSecure data point and event logging
sPowerful report generation
sDetailed audit trails
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.

An integrated BMS is the central

nervous system of your facility
A smart facility is a smooth running and protable facility
Capital Procurement and Operating Efciency
Integrated BMS solutions yield cost savings and operational benets. A recent
case study identied cost savings of over 24% for an integrated BMS solution
The U.S. pharmaceutical
industry consumes
OZ[]abPWZZW]\CA2
in 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.

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, computing 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 Human Resources databases.

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.

Energy and Building Management Solutions for Life Sciences

Simple software integration

Interoperable and open to third-party systems

Eco

truxure

Green: Make renewable energy sources

reliable and cost effective

Renewable energies
HVAC control
Lighting control

Make Energy Efcient & Productive:

Energy monitoring & control

Motor control
Access control

 Measure, control, automate, and

diagnose processes and systems
 Make all utilities more efcient

Security
Critical power & cooling
Electrical distribution

Reliable: Prevent power outages & quality variances

Safe: Transform and distribute power safely

Put our experience to work

for you
Youll be glad you did
The Strength of Schneider Electric for
Life Sciences
Schneider Electric offers compatibility and
synergy through fully integrated building management 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 building systems, helping to manage regulatory and
business risks while optimizing life sciences facility
value.

About Schneider Electric

As 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
Schneider Electrics high
technology approach
provides us with the
best of whats out there.
And the company
continues to respond
to our needs.

Make the most of their energy.

www.schneider-electric.com/buildings

Sabi Bivas ,
Senior Systems
Associate, Merck & Co.

"

Schneider Electric
employees available
to help you



countries with Schneider

Electric locations ready
to serve you

 2007-2010 Schneider Electric. All rights reserved.

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
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This document has been

printed on recycled paper

October 2010

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