Over the past few months, the life sciences practice has produced several free resources related to the 21 CFR Part 11 regulation that governs electronic records and electronic signatures. To make it easy for our industry colleagues to find those resources, we decided to create a single blog post that links to all of them.
As always, if you have any questions about anything we discuss or could use some guidance on a compliance-related situation you’re facing in your organization, feel free to contact us. In the meantime, enjoy all of the resources!
21 CFR Part 11 Decoder Ring Blog Series
- The 21 CFR Part 11 Decoder Ring
- 21 CFR Part 11 Decoded: Scope
- 21 CFR Part 11 Decoded: Implementation
- 21 CFR Part 11 Decoded: Definitions
- 21 CFR Part 11 Decoded: Controls For Closed Systems
- 21 CFR Part 11 Decoded: Controls For Open Systems
- 21 CFR Part 11 Decoded: Signature Manifestations
- 21 CFR Part 11 Decoded: Signature/Record Linking
- 21 CFR Part 11 Decoded: Electronic Signature General Requirements
- 21 CFR Part 11 Decoded: E-Signature Components And Controls
- 21 CFR Part 11 Decoded: Controls For ID Codes/Passwords
- 21 CFR Part 11 Decoded: One Final Look
Decoding 21 CFR Part 11 Webinar
The Ultimate Guide to 21 CFR Part 11
21 CFR Part 11 Webinar Questions and Answers
- Are Hosted Systems Open Or Closed Under 21 CFR Part 11?
- Is A Web-Based QMS Required To Comply With 21 CFR Part 11?
- Is A Training System Required To Comply With 21 CFR Part 11?
- How Are GAMP 5 And 21 CFR Part 11 Related, If At All?
- How Much System Access Should We Give An FDA Inspector?
- Are Test User Accounts Subject To 21 CFR Part 11?
- Does 21 CFR Part 11 Apply to CTMS, CDMS, Or EMR/EHR Systems?
- Are Email Attachments Subject To 21 CFR Part 11?
- Who Should Notify The FDA About Using Esigs: CRO Or Sponsor?
