19
Jul

FDA 21 CFR Part 11 Compliance: A Practical Guide for Calibration Managers

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.

FDA Compliance

What is FDA 21 CFR Part 11?

It ensures that digital records are trustworthy, reliable, and equivalent to handwritten records.

Audit Trails

Every change to a record must be logged—with user, timestamp, and reason.

Electronic Signatures

Signatures must be secure, unique, and traceable to an individual.

System Access Controls

Only authorized users should have access to view or edit calibration data.

How PrecisionCal Helps

  • ✅ Secure login and role-based access
  • ✅ Full audit logs on all calibration activity
  • ✅ Electronic signatures compliant with FDA requirements
  • ✅ Validation-ready software documentation

PrecisionCal makes Part 11 compliance simple, traceable, and audit-proof.

PrecisionCal Team / Compliance Experts

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