Gone are the days of paper-based quality systems as the “norm.” Sure, you can still use paper-based records for official documentation and the U.S. Food and Drug Administration (FDA) won’t mind (too much). Sure, you can even keep a web of siloed spreadsheets and/or standalone document folders and/or archived paper documents in cold storage, etc. with handwritten approval signatures. But, why?
With many options for digital transformation available in the quality software sector there’s never been more opportunity to digitize your quality management system (QMS).
The statement above sounds great. But you may be wondering, “What’s the catch?” Well, if you want to call it a “catch,” using a purpose-built digital quality management system facilitates compliance with FDA 21 CFR Part 11, and diminishes the risks associated with noncompliance. Below is a short explanation of 21 CFR Part 11 and a brief list of things to consider when looking at digital QMS solutions.
21 CFR Part 11 outlines the FDA-approved guidelines for the digital storage and usage of electronic records and signatures as official, auditable documentation in place of paper-based documentation and pen-and-ink signatures. The following is a brief explanation of the FDA’s expectations for electronic records, signatures, and software validation, along with questions to ask when looking at your digital QMS options.
To maintain 21 CFR Part 11 compliance, electronic records must be housed in a secure digital system with clear, auditable document approval trails that can’t be easily accessed by outside parties.
What to ask:
To maintain 21 CFR Part 11 compliance, electronic signatures must be used and tracked in a way that excludes the possibility of refuting any signature as not genuine.
What to ask:
To maintain 21 CFR Part 11 compliance, a software system must be validated and easily accessible for FDA review.
What to ask:
To learn more about how to avoid noncompliance to 21 CFR Part 11, as well as more about what to look for in a digital QMS solution, read MasterControl’s new industry brief, “21 CFR Part 11: 7 Ways to Avoid Noncompliance.”
Enjoying this blog? Learn More.
21 CFR Part 11: 7 Ways to Avoid NoncomplianceDownload Now
Support for the Internet Explorer browser will end on June 15, 2022 and some site features may be unavailable. For the best experience, we recommend using a modern web browser such as Google Chrome, Mozilla Firefox or Microsoft Edge.