FDA 21 CFR Part 11 Checklist

There’s a lot of misunderstanding and misinformation out there about the exact requirements of FDA 21 CFR Part 11. 

So, here are the facts. You don’t need expensive biometric and digital signature encryption solutions to meet the regulation.  

But you do need the right admin control, authentication protocols and ‘signature manifests’ to ensure data integrity and traceability throughout your development process.