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Facing Part 11 and Data Integrity Requirements With Confidence Travis Cox Fri, 07/12/2019 - 11:53
Like all industries, companies in the pharmaceutical and biotechnology industries are concerned with protecting and getting more insight from their data. Additionally, the issues of electronic-record and electronic-signature management and data integrity have become increasingly important for these industries in recent years. This has been driven by 21 CFR Part 11 and ALCOA standards, which are in place to help ensure the quality and safety of all pharmaceutical products.