[ COMPLIANCE ]
ENSURING QUALITY
THROUGH COMPLIANCE
BEING IN COMPLIANCE HAS NEVER BEEN MORE IMPORTANT
Quality 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 ]
EXAMPLES OF INDUSTRIES WATERS
COMPLIANCE SERVICES SUPPORT:
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.
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Cosmetic
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Food
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Drug
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Environmental
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Clinical
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Natural Products
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Tobacco
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.
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That doesn’t mean you are
on your own
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.
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Waters 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.
[ COMPLIANCE ]
.
COMPLET E SERV IC ES TO MEET
YOUR COMPLIANC E NEEDS
Waters 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:
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Instrument Qualification
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Software Qualification
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Validation Consultancy Services
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Other Professional Services including Training
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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For Waters, compliance is
not an afterthought
SOF T WARE DESIGNED
WIT H COMPLIANC E IN MIND
Our 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.
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The Empower SystemsQT™ Qualification Tool enables a wholesystem 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.
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:
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Empower 3 Chromatography
Data Software (CDS)
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NuGenesis® Laboratory
Management System (LMS)
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MassLynx® Software
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UNIFI Scientific
Information System
[ COMPLIANCE ]
INST RUMENT AND SYST EM
QUALIFICAT 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.
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Qualification/Calibration Chemistry Kits include specially
prepared solutions with the appropriate certificates to be used
with our instrument system qualification products and services.
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Qualification Workbooks provide easy-to-use protocols for
performing Installation Qualification (IQ), Maintenance Procedures
(MP), Operational Qualification (OQ), and vendor Performance
Qualification (PQ).
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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.
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.
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.
ACQUITY UPLC H-Class System
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VALIDATION
CONSULTANCY SERVICES
Computer 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.
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:
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Meet regulatory requirements
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Prove the solution is fit for
its intended use
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Gain information that
demonstrates the quality
of your process and products
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.
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[ COMPLIANCE ]
OT HER P ROFESSIONAL SERV IC ES
INC LUDING T RAINING
Our Professional Services team offers a wide range
of services, including:
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Assessment Services
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Project Management
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Method Development and Transfer
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Method Optimization and Application Support
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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 selfdirected qualification training so that you can perform your system
qualification without the assistance of a Waters Compliance
Services Specialist.
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COMPLIANCE CAN BE COMPLICATED
BUT IT DOESN’T HAVE TO BE
Compliance 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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www.waters.com/compliance
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Waters Corporation
34 Maple Street
Milford, MA 01757 U.S.A.
T: 508 478 2000
F: 508 872 1990
www.waters.com
Waters, T he Science of W hat’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