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The FDA’s Quality Management System Regulation now builds on ISO 13485:2016. Here is what changed, what investigators will look for, and how ENSUR supports the ISO 13485 workflows your quality system runs on every day.
Tags: document control software, quality management software, Electronic Signature, Compliance, audit readiness, 21 CFR Part 11, FDA
A practical guide to the 21 CFR Part 11 criteria your e-signature workflow must meet, and how to evaluate the systems that claim to meet them.
Tags: document control software, quality management software, Electronic Signature, Compliance, audit readiness, 21 CFR Part 11, FDA