Life Sciences Building Management Solutions

Pipeline, timeline, deadlineImprove your bottom line

Put your buildings to work for you

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.

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).

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

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

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

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

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

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.

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.

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.

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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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