The biopharmaceutical industry finds itself under increasing pressure to focus on Data Integrity (DI). Auditors require companies to ensure that appropriate DI controls are implemented and appropriately managed throughout the data lifecycle. While industry comes to grips with the complexities of data integrity in their global supply chain, a series of webinars on DI are planned to assist your understanding on how to identify data integrity problems in your company and the steps you need to take to remediate them. Each webinar is designed to address a specific DI issue such as how to establish a corporate DI program, where does DI fit in the data lifecycle, mapping DI to existing predicate rules and how to design for DI during SDLC etc.
This is the first webinar in the series. It addresses DI concepts, fundamentals and their attributes. This understanding is essential for the uncovering of potential DI problems in a company.
Data integrity has been at the forefront of the recent news. Regulators are increasingly focusing on data integrity. Audits are unraveling data integrity vulnerabilities arising from data loss during transport and data corruption during data storage and recall.
Establishing data controls is a key to ensuring data integrity. The onus is on the system users to understand and use existing regulations such as CFR 21 Part 11 and Annex 11 to design system controls to detect and document all data changes to make them trustworthy. Subsequently, the designed systems must be validated by taking into consideration all aspects of data integrity.