ENSURING QUALITY THROUGH COMPLIANCE

[ COMPLIANCE ]

BEING IN COMPLIANCE HAS NEVER BEEN MORE IMPORTANTQuality encompasses more than meeting regulatory requirements. It extends throughout your organization as a standard for analytical results. Being in compliance with both your own and regulatory standards, results in improved productivity through less downtime due to data integrity questions and greater efficiency.

Making sure that your results are reliable, accurate and trustworthy is something every organization values. Being in compliance demonstrates to both your customers and regulatory authorities that your laboratory produces quality data. Your reputation builds your success.

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Compliance is required...by every regulated industry and in nearly every nation. Whether it

is complying with strict regulations from the United States Food and

Drug Administration, the European Directorate for Quality Medicines,

or other regulators overseeing a wide range of industries, it is every

company’s responsibility to comply with the regulations and provide

the data to prove it.

Companies face substantial financial impact

if they are unable to quickly provide regulators

with the required data, including documented

evidence of Compliance. Waters can be the

partner that helps you confidently meet

those requirements.

THE PREDICATE RULES

The United States FDA, like

all worldwide regulators, has

established specific requirements

and procedures for how

companies collect, maintain,

and submit records and

signatures. Our thorough

understanding of these rules

enables us to advise you in

your laboratory operations

and translate requirements

globally, so you can achieve

full compliance in every country

where you do business.

[ COMPLIANCE ]

EXAMPLES OF INDUSTRIES WATERS COMPLIANCE SERVICES SUPPORT:

■■ Cosmetic

■■ Food

■■ Drug

■■ Environmental

■■ Clinical

■■ Natural Products

■■ Tobacco

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THE CORE OF COMPLIANCE

Qualification

Testing an instrument system

or software at a specific

moment in time and

verifying, with documented

evidence, that it meets

predefined specifications.

Validation

Verifying with documented

evidence that an instrument

system or computerized

laboratory system

continuously operates in

a controlled and compliant

manner throughout its life.

That doesn’t mean you are on your ownWaters offers a suite of Compliance Services to make it easier to meet

quality goals and regulatory requirements. We conduct our tests the way

you actually use your instruments to ensure that all components are fit

for purpose. We have sophisticated informatics solutions to document

your processes. Most importantly, we design our instruments and our

software with compliance in mind.

There is also the human factor. Our consultants can help you to achieve

greater efficiency and effectiveness in preparing documentation which

supports internal and external audits as well as regulatory inspections.

You can rely on our decades of experience throughout the world to help

you establish – and maintain – control of your quality standards and

compliance with applicable regulations.

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COMPLET E SERV ICES TO MEET YOUR COMPLIANCE NEEDSWaters Compliance Services can simplify the process of qualification,

validation, and record-keeping so that your business can focus on

delivering products to market. We work with you to make sure you are

able to meet the regulations in your industry and in the countries where

you conduct business.

Waters offers:

■■ Instrument Qualification

■■ Software Qualification

■■ Validation Consultancy Services

■■ Other Professional Services including Training

[ COMPLIANCE ]

These services are available to our customers using LC, LC-MS, GC,

and GC-MS Systems as well as Waters Informatics Solutions in

regulated environments. Many of the compliance tools utilized

by our services professionals are also available for customer use.

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SOFT WARE DESIGNED WITH COMPLIANCE IN MINDOur Informatics Solutions each provide a powerful set of technological

tools and controls that, together with administrative and procedural

controls, allow your organization to meet regulatory expectations

for data integrity. These capabilities are fully integrated into the

software operations, providing you with seamless control over your

Waters instrument systems as well as many instruments from other

major vendors.

For example, our System Qualification tools are built into Empower® 3

and UNIFI®, saving time and money in performing and reviewing the tests.

Critically, through the built-in database, you also have easy access to the

complete testing data in case of an audit.

■■ The Empower SystemsQT™ Qualification Tool enables a whole-

system automated test approach for more accurate indication of

overall system-level performance. Empower provides secure, online

qualification data storage for easy access and traceability, as well as

simplified data review with the capability of electronic sign-off.

■■ The UNIFI Qualification Center expands on the functionality of

SystemsQT and adds a unique qualification center that provides

the ability to run, store, manage, and approve qualification data.

Automated and manual methods can be run, processed, and then

documented in one central location.

For Waters, compliance is not an afterthought

RECORD AND DOCUMENT YOUR QUALITY

Waters Informatics Solutions

provide essential record

keeping, organization, and

output to verify your processes.

Depending on your system and

needs, we offer:

■■ Empower 3 Chromatography

Data Software (CDS)

■■ NuGenesis® Laboratory

Management System (LMS)

■■ MassLynx® Software

■■ UNIFI Scientific

Information System

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.

For Waters, compliance is not an afterthought

INST RUMENT AND SYST EM QUALIF ICAT ION Waters offers a wide variety of options to qualify your instrument

systems. Waters’ qualification tools are designed to demonstrate

the chromatographic performance of your hardware in the way it is

intended to be used.

■■ Qualification/Calibration Chemistry Kits include specially

prepared solutions with the appropriate certificates to be used

with our instrument system qualification products and services.

■■ Qualification Workbooks provide easy-to-use protocols for

performing Installation Qualification (IQ), Maintenance Procedures

(MP), Operational Qualification (OQ), and vendor Performance

Qualification (PQ).

■■ Self-Directed Qualification makes the same advanced technologies

used by our Compliance Services Team available to you. By completing

a training program and using our tools and accessories, your internal

staff or metrology team can perform your own system qualifications.

The resultant information provides confidence the system is going to

perform and give results as intended.

[ COMPLIANCE ]

SOFTWARE QUALIFICATION

All Waters software can be deployed with

routine Installation Qualification (IQ) and

Operational Qualification (OQ) services

and documentation, providing a base

qualification platform and demonstrating

that the deployment meets our expected

performance requirements.

Waters Validation Consultants also

provide a service extending these basic

qualification services to include testing

of a more detailed list of functional or

user requirements. These services might

include paper based qualification testing

of software for some of our applications,

but also may leverage unique automation

tools such as the Advanced Verification

Technology tool for Empower 3.

BENEFITS TO AUTOMATED TESTING

Concentrate your laboratory time on your

business, not on qualification testing.

Waters automated Compliance Services

test your systems while requiring

significantly reduced instrument downtime.

Automation allows you to quickly

qualify multiple systems or multiple

computers at the same time.

ACQUITY UPLC H-Class System

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VALIDATION CONSULTANCY SERVICESComputer Systems Validation (CSV) can be a time-consuming, complex

activity requiring the time and effort of multiple domain experts. Helping

you to keep current with new technologies and managing the overhead

of deploying new or upgraded software with minimal disruption to your

workflow is a core goal for us. We understand that keeping in compliance

with regulatory and internal expectations is an ongoing part of business,

and that a comprehensive system validation program must include

maintaining and protecting a system’s validated state throughout its

operational life cycle.

Computer Systems Validation services are available for Empower

Software, as well as other Waters Enterprise software products.

These services can significantly reduce the time needed to develop

documentation, and perform various activities of the validation process.

Waters’ Validation Consultants can work with you to develop customized

tests that cover customer specific user/functional requirements and

test outcomes.

Not only can Waters Validation Consultancy Services allow you to

accelerate the installation, testing/verification, and configuration of

a validation project, we can also facilitate the entire process – from initial

product planning to final validation reporting.

With Waters, you have access

to the full range of Validation

Consultancy Services that will

help accelerate the deployment

of your new or updated systems

and provide confidence that your

laboratory will:

■■ Meet regulatory requirements

■■ Prove the solution is fit for

its intended use

■■ Gain information that

demonstrates the quality

of your process and products

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OTHER PROFESSIONAL SERV ICES INCLUDING T RAININGOur Professional Services team offers a wide range

of services, including:

■■ Assessment Services

■■ Project Management

■■ Method Development and Transfer

■■ Method Optimization and Application Support

■■ Informatics and Systems Training Solutions

Technologies and requirements can change quickly, and Waters’ training

keeps your knowledge current. We offer Educational Services: classroom

and web-based courses to keep you up-to-date on the technologies,

products, and their use in regulated environments. We also offer self-

directed qualification training so that you can perform your system

qualification without the assistance of a Waters Compliance

Services Specialist.

[ COMPLIANCE ]

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COMPLIANCE CAN BE COMPLICATED BUT IT DOESN’T HAVE TO BECompliance requires qualification of every critical piece of your system – hardware and software. Then, the entire system, including

procedures performed by certified users, must be validated to show that it is fit for your intended purpose. Waters’ experience can

help you to streamline the process of achieving your compliance goals.

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[ COMPLIANCE ]

Waters has the services and the expertise to help you be compliance-ready.

Contact Waters and add our technologies, knowledge and experience to your own.

We can help you to demonstrate that your organization meets compliance requirements

confidently, enabling you to generate the highest quality results.

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Waters, The Science of What’s Possible, Empower, UNIFI, NuGenesis, and MassLynx are registered trademarks of Waters Corporation. SystemsQT is a trademark of Waters Corporation. All other trademarks are the property of their respective owners.

©2015 Waters Corporation. Printed in the U.S.A.February 2015 720005222EN AO-SIG

www.waters.com/compliance