21 CFR Part 11 : Electronic Signature & LMS compliance

The FDA’s data integrity requirement calls for evidence of authenticity. In other words, when someone—let’s call her Mary—is validated on a standard operating procedure (SOP), we need to ensure that she is authenticated, meaning that no one else was logged in to read the SOP for her. This is a part of individual responsibility in a life sciences company and implies liability in case of an incident, inspection, or audit. 

The data integrity requirement applies to any life sciences laboratory or manufacturing company that generates, maintains, edits, saves, and stores electronic records. Data integrity is critical for clinical studies where efficacy and non-toxicity are at stake, and constitutes the core of the activity. You wouldn’t want new drugs’ clinical research to be based on unreliable data or untraceable conclusions, would you? 

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