Data integrity requirements have been addressed in the FDA’s Title 21 CFR Part 11 and the EU's GMP Eudralex Volume 4, Chapter 4 and Annex 11. This is so far unchanged. However, with increasing automation based on computerized systems, as well as the globalization of operations and the increasing cost of bringing products to market, new guidance was needed to clarify regulatory expectations around the creation, handling and storage of data. The following eight recommendations give an overview of how to maintain data integrity for computerized systems.
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* See EU GMP EudraLex Annex 15: “Where validation protocols and other documentation are supplied by a third party providing validation services, appropriate personnel at the manufacturing site should confirm suitability and compliance with internal procedures before approval.”
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