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19
Jul
If you’re in the life sciences or medical device sector, compliance with FDA 21 CFR Part 11 is non-negotiable. This regulation governs the use of electronic records and electronic signatures (ERES) in place of paper documentation.
Let’s break it down simply.
It ensures that digital records are trustworthy, reliable, and equivalent to handwritten records.
Every change to a record must be logged—with user, timestamp, and reason.
Signatures must be secure, unique, and traceable to an individual.
Only authorized users should have access to view or edit calibration data.
Stay updated with the newest articles, regulatory changes,
and expert advice from the PrecisionCal team.