Empower Tips: Ask Me Anything About Durable Data and Intrinsic Compliance

Data integrity is critical for all laboratories. The Life Sciences GxP regulations and ISO 17025 have so clearly defined the requirements and expectations for data integrity as the endpoint, i.e., data that is complete, accurate and available; however, a regulated company needs to implement an effective framework to truly realize that endpoint.

Reviewing trends can help you to identify areas to monitor in your own organization. In an analysis of Warning Letters, 30% of issues were related to original data, over 25% involved data manipulation, 14% related to system controls, and approximately 14% involved data destruction.1 When considering compliance history as a driver for reinspection frequency, the Australian regulatory agency TGA categorizes compliance attitudes as follows:

• Voluntary Compliance: committed to do the right thing
• Accidental Non-Compliance: trying to do the right thing but don’t always succeed
• Opportunistic Non-Compliance: don’t want to comply but will if made to
• Intentional Non-Compliance: decision not to comply

Now it’s time for industry to set the bar higher, and target a new attitude to ensure patient safety:

• Intrinsic Compliance: where data integrity, as a foundation to compliance, is so inherent in the business processes and computerized systems that it just happens without conscious thought or action.

This presentation will look at the global best practices for data governance and how to achieve robust data integrity within the complexities of balancing people, process and technology and across the complete data lifecycle.

Presenter: Neil Lander (Principal Product Manager, Waters Corporation)

Neil has worked for Waters Corporation since 1994 and has held a variety of positions including Technical Support Specialist, Technical Trainer, Manager Customer Education and currently, Principal Marketing Manager focusing on Informatics solutions. He provides internal support for Empower Chromatography Data System and is focused on developing laboratory software solutions that help organizations achieve their scientific and operational objectives. Prior to joining Waters, he was an analytical chemist where he gained experience in both the cosmetics and specialty chemical industries.

Presenter: Charlie Wakeham (APAC GxP Compliance Manager, Waters Corporation)

Charlie Wakeham is the APAC GxP Compliance Manager for Waters Corporation, where she leverages her compliance experience and expertise to enhance Waters product positioning, marketing strategies and validation offerings. She currently serves as Secretary of the ISPE GAMP Global Council and on the GAMP Data Integrity SIG Leadership Team. Charlie was awarded ISPE Member of the Year in 2019 for her volunteer activities within GAMP and for her training of Health Authority inspectors across Asia Pacific.