21 CFR Part 11: Electronic Records & Signatures Explained

See our 21 CFR Part 11 Compliance Guide: https://softwareconnect.com/go/21-cfr-11-compliance-guide-00cc2 What is 21 CFR Part 11? It’s an FDA rule that sets requirements for electronic records and signatures, treating them as equivalent to paper records with handwritten signatures. Most FDA-regulated companies don't realize how exposed they are until an auditor shows up. This video explains what 21 CFR Part 11 is and outlines its requirements. It also shows where companies most commonly get it wrong and how to stay compliant with Part 11. Featured 21 CFR Part 11 Software: Octave Reliance: https://softwareconnect.com/go/octave-reliance-review-b3042 QAD EQMS: https://softwareconnect.com/go/qad-eqms-review-70527 QT9 QMS: https://softwareconnect.com/go/qt9-qms-review-91429 Get tailored recommendations: https://softwareconnect.com/go/get-free-consult-6dd9f Timestamps: 0:00 – Intro 0:30 – What is 21 CFR Part 11? 1:27 – Part 11 requirements 3:13 – Where companies most commonly get it wrong 4:09 – Fixes you can do right now 4:50 – Recommended QMS Systems #21CFRPart11 #FDACompliance #QMSSoftware #PharmaSoftware #MedicalDevices #QualityManagement #qualitymanagementsystem