ENSURING QUALITY THROUGH COMPLIANCE [ COMPLIANCE ]

ENSURING QUALITY THROUGH COMPLIANCE [ 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. 2

[ COMPLIANCE ] EXAMPLES OF INDUSTRIES WATERS COMPLIANCE SERVICES SUPPORT: Cosmetic Food Drug Environmental Clinical Natural Products Tobacco 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. 3

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. 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. Validation Verifying with documented evidence that an instrument system or computerized laboratory system continuously operates in a controlled and compliant manner throughout its life. 4

[ COMPLIANCE ]. COMPLETE SERVICES TO MEET YOUR COMPLIANCE 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: Instrument Qualification Software Qualification Validation Consultancy Services 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. 5

For Waters, compliance is not an afterthought SOFTWARE DESIGNED WITH COMPLIANCE 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. 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: Empower 3 Chromatography Data Software (CDS) NuGenesis Laboratory Management System (LMS) MassLynx Software UNIFI Scientific Information System 6

[ COMPLIANCE ] INSTRUMENT AND SYSTEM QUALIFICATION 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 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. 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. 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 7

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: Meet regulatory requirements Prove the solution is fit for its intended use 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. 8

[ COMPLIANCE ] OTHER PROFESSIONAL SERVICES INCLUDING TRAINING Our 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 selfdirected qualification training so that you can perform your system qualification without the assistance of a Waters Compliance Services Specialist. 9

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. 10

[ 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. 11

SALES OFFICES: Austria 43 1 877 18 07 Australia 61 2 9933 1777 Belgium and Luxembourg 32 2 726 1000 Brazil 55 11 4134 3788 Canada 1 800 252 4752 China 86 21 6156 2666 Czech Republic 420 2 617 11384 Denmark 45 46 59 8080 Finland 358 9 5659 6288 France 33 1 30 48 72 00 Germany 49 6196 400 600 Hong Kong 852 2964 1800 Hungary 36 1 350 5086 India 91 080 49292200 03 Ireland 353 1 448 1500 Israel 9723 3731391 Italy 39 02 265 0983 Japan 81 3 3471 7191 Korea 82 2 6300 9200 Mexico 52 55 52 00 1860 The Netherlands 31 76 508 7200 Norway 47 6 384 6050 Poland 48 22 101 5900 Portugal 351 21 893 61 77 Puerto Rico 1 787 747 8445 Russia/CIS 7 495 727 4490/336 7000 Singapore 65 6593 7100 Spain 34 93 600 9300 Sweden 46 8 555 115 00 Switzerland 41 56 676 7000 Taiwan 886 2 2508 5500 UK 44 208 238 6100 US 1 800 252 4752 www.waters.com/compliance Waters Corporation 34 Maple Street Milford, MA 01757 U.S.A. T: 508 478 2000 F: 508 872 1990 www.waters.com 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