Case Study

How Logilab ELN helps organizations to maintain ALCOA Data Integrity

How Logilab ELN helps organizations to maintain ALCOA Data Integrity

How Logilab ELN helps organizations to maintain ALCOA Data Integrity Importance of Data Integrity Data integrity, an area of increasing priority in today’s laboratory world and “The focus area” when it comes to regulatory compliance such as 21 CFR Part 11 and Eudralex Annex 11. The US Food and Drug Administration (FDA) guidance on data integrity, issued in December 2018 (1), set new standards for all research companies. Under the new guidelines, “firms should implement meaningful and effective strategies to manage their data integrity risks”. A major concern of biopharmaceutical R&D executives is implementing these strategies in order to maintain data integrity throughout the entire drug discovery and development lifecycle – crucial for shortening drug time to

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