Pipeline, timeline,

deadline
Improve your bottom line

Life Sciences
Building Management Solutions
Put your
buildings to
work for you
Keep your product
pipeline flowing
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

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

Benefit 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 qualification, 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 efficiencies
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
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 qualified BMS.
The need for more powerful, integrated and
secure building management solutions is tied to
evolving regulatory compliance and increasing
business challenges.
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.

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
How a Schneider Electric BMS contributes
predicate rules. 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 qualified life sciences

facilities built to specification, 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 flexible,
scalable architectures that grow and adapt over the lifetime of your facility.

Scenario
tric
Elec
er
id
hne
c
Scenario
S

blem
o
Acceleration Pr
- Revenue +

of ROI

$0.00

Approval Launch
Pre-clinical Clinical Manufacturing Promotion Competition
Studies Trials
Time to Market
Typical drug life cycle/return on investment
Take the most direct route from
design to qualification
Well lead you down the right path
Even in an environment as complex as yours, a sophisticated BMS solution
can find efficiencies 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 qualification efforts
to areas of specific regulatory interest. This ensures on-time delivery of
value-optimized and properly validated facilities.

Applicable regulations and guidance documents:

T itle 21 Code of Federal Regulations (CFR)
Parts 11, 58, 210, 211, 600, 610, 820
GxPs, GAMP5, Q7A

Corporate Offices

Manufacturing Central Utilities

Operations

Clinical Supply Animal Facilities

Warehousing Research
& Distribution & Discovery

Building Management System

GxP Non GxP Mixed

Our clients include: Amgen Inc.; AstraZeneca; B. Braun Medical Inc.; Bayer AG; Biogen Idec; Boston Scientific 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; Pfizer Inc.; Sanofi-aventis; STERIS Corporation; The American National Red Cross.
Critical facility issues have no
place to hide
Manage your total environment
Who is in the
Total Environment Management laboratory right now?
Where was the security
Total Environment Management (TEM) is 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,
What is the Mean
where, and who was involved. 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
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 fulfillment of system requirements
with the use of a fully qualified, independent system
to monitor, log, and report.
Control Parameter Calibration
Management Management
Control & Processing
Measurement/Outputs
Schneider Electric systems can support this
approach, but a single BMS, designed so that the
direct impact subsystems are identified, partitioned,
and validated, fulfills the same requirements. The
result is tighter control with the same degree of
monitoring integrity. This approach yields cost-
efficiencies from initial capital procurement through
the operational life of the system.
Reporting
Alarm & Event
Data Logging
Logging
Monitoring
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.

Exacting criteria are applied to filter, group, and

correlate information. This ensures that evidence Examples:
required for proof of regulatory compliance is not Regulated space
lost within all the data a BMS system collects. Other temperatures,
data are of great business and operational interest pressures, airflows,
to managers; to regulators, they are superfluous setpoint changes,
access records
and distract from their target of interest.
Air handler

Importance
Regulatory
Schneider Electrics Project alarms, server
Requirements
room environment
Delivery Approach
Consistent use of field- and time-proven Bu l Equipment run-
s in e ca
s s Cri ti times, filter
methodologies, along with rigorous ISO 9001 Bu
s ines le
quality controls, combined with skilled project and Al
lF s Valuab rs
differential pressures
aci
l i ty m e te
account management, contribute to the superior Events & Para Office space
results you can expect from Schneider temperatures, parking
lot barrier position
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
System Design System Test
with architecture, engineering, and construction Specifications Specifications
management firms prevalent in life sciences
User PQ Test Plan Performance
strengthen our delivery capability. Requirements Qualification

Schneider Electric Validation Toolkit

Functional OQ Test Plan Operational
Schneider Electrics Validation Toolkit is a
Design Qualification
comprehensive set of guidelines and customizable
IQ Test
templates designed to support qualification of Plan
Schneider Electric systems in regulated industries. Detailed Installation
Design Qualification
It is based on industry standard methodologies as
outlined in GAMP5A Risk-based Approach to
Compliant GxP Computerized Systems. Schneider Implementation
Electric leveraged decades of expertise within its
From initial system specifications through qualification of the installed system, the Schneider
Life Sciences team to develop this toolkit. Countless Electric Validation Toolkit provides comprehensive support to the entire process.
facilities, ranging from Active Pharmaceutical
Ingredient (API) production plants to clinical
laboratories, have been qualified and met regulatory
approval by employing these methodologies.

The Schneider Electric Validation Toolkit Contains: Sample Applications, Project Planning Guide, Project Quality Assurance Manual,
User Requirements Specification (URS), Functional Specification (FS), Detailed Design Specification (DDS), Factory Acceptance Test
(FAT), Site Acceptance Test (SAT), Project Validation Plan, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification
(PQ), Summary Qualification 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 configured 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
SQL Server facilities.
Luc Pelletier,
Facility Director,
Hma-Qubec

Secure
Server
GxP Areas Room
Non-GxP Areas

Facility Facility Facility

Management Management Management
Workstation Workstation Workstation

Digital Video
Recording
Door Supervisory Door Supervisory
Module Controller Module Controller
Access Access
Control & Biometric Control & Lighting
Monitoring Sensors Monitoring

Air Fume Fire

Handling Hoods Central Systems
Unit Field Plant Field
Controller Controller

Intrusion Intrusion
Monitoring Monitoring
Terminal VAV Terminal VAV
Unit Controller Unit Controller
Particulate Power
Monitoring Monitoring

Touch Screen
Secured Resources Display
Lower cost. Lower risk.
Guaranteed performance.
Expertise you can count on

Laboratory/Clean Room Expertise ceilings together with security, electrical,

Management of a laboratory or clean room serves lighting, and control systems are integrated to
as a prime example of the advantages of an deliver a performance guaranteed environment.
integrated control system because these spaces
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
ISO 14644 Standards
supported by Schneider Electric systems,
ISO Cleanliness
integration of complementary specialist devices
Classes 1 through 8
and subsystems like particulate monitors and fume
Biosafety Levels
hood controls is easily realized. 1 through 4

Schneider Electric has broad experience and a

well established track record of building these
projects, offering turn-key services including design,
installation, commissioning, and validation. All
system components such as floors, walls, 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 modified. For any or all events, TAC Vista can
be configured so that operators must confirm 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:
Comprehensive password management
Enforced operator explanation for all alarm acknowledgements
Alarm generation for invalid and disabled user login attempts
Secure data point and event logging
Powerful report generation
Detailed audit trails

The CFR Compliance Pack adds to these capabilities with powerful archiving
and reporting tools allowing you to create PDF files protected with digital Typical operator dialog screens
signatures. For all system changes, operators can be forced to provide for a critical alarm condition.
electronic signatures and an explanation of their actions.
An integrated BMS is the central
nervous system of your facility
A smart facility is a smooth running and profitable facility

Capital Procurement and Operating Efficiency

Integrated BMS solutions yield cost savings and operational benefits. A recent
case study identified cost savings of over 24% for an integrated BMS solution
The U.S. pharmaceutical
compared to a more traditional separate systems approach. Due to its
industry consumes
highly distributed nature, the BMS is pervasive throughout a facility and almost $1 billion (USD)
offers a natural integration platform for all building systems. In effect, the in energy annually. How
BMS acts as the central nervous system of a facility. is that affecting your
bottom line? Schneider
Electric can help you
Schneider Electrics leadership in open systems technologies supports the position yourself in the
integration of a diverse range of disparate devices and subsystems into Dow Jones Sustainability
Index significantly
unified, highly functional solutions. Included among the open technologies
improving your image
we champion and support are BACnet, LonWorks, Modbus TCP, OPC and your financial
and XML. Progressive life sciences companies use their BMS infrastructure performance by focusing
to integrate electrical, utilities, process, access control, and fire and life safety on energy efficiency. So,
what is the first step?
systems together. The BMS has the communications bandwidth, computing
Set energy savings goals
power and database capacity to provide a common interface from these and measure and track
subsystems for centralized engineering and enterprise level functions such energy performance for
as maintenance management, Manufacturing Execution Systems (MES) and all operations across
your business.
Human Resources databases.
How? Take that first
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

Renewable energies
reliable and cost effective
HVAC control
Lighting control
Make Energy Efficient & Productive:
Energy monitoring & control
Measure, control, automate, and
Motor control diagnose processes and systems
Make all utilities more efficient
Access control
Security
Critical power & cooling Reliable: Prevent power outages & quality variances

Electrical distribution 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 efficient, the companys 130,000
employees achieved sales of more than 22.4 billion
euros in 2011, through an active commitment to
help individuals and organizations Make the most
Schneider Electrics high
of their energy.
technology approach
provides us with the
www.schneider-electric.com/buildings best of whats out there.
And the company
continues to respond
to our needs.
Sabi Bivas ,
Senior Systems
Associate, Merck & Co.

130,000 Schneider Electric

employees available
to help you 100+ countries with Schneider
Electric locations ready
to serve you
 2007-2012 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 This document has been
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