21 CFR Part 11 Workshop
Prepare your software for FDA or other regulated markets
Understand what 21 CFR Part 11 really requires and how to build systems that meet it
This workshop provides a clear, practical overview of 21 CFR Part 11 regulation and its application in software development.
You’ll learn how to assess your system, identify missing features, and plan technical and documentation updates that align with FDA expectations.
Ideal for teams developing ELNs, LIMS, or any software intended for pharma, biotech, or diagnostic companies operating in regulated markets.
What you will learn
What 21 CFR Part 11 really covers and how it compares to Annex 11
Key concepts: data integrity, traceability, audit trails, electronic signatures
Technical vs. policy solutions; how to split responsibility
Which features are must-haves, and which are “nice-to-haves”
How to upgrade your existing software to meet CFR requirements
Examples from real projects
Who should attend?
Software developers and architects
QA/RA teams
Product managers and tech leads
Companies targeting FDA-regulated markets
Delivered by
BioSistemika team of senior software engineers, regulatory specialists, and project leads with hands-on experience in CFR-ready systems development.
BONUS: Participants receive a CFR-readiness checklist and implementation guide.
Let’s talk about your team’s training needs
Contact us to plan an internal session for your company.
