Articles tagged with “fda-compliance”

Validating Generative AI in GxP: A 21 CFR Part 11 Framework

Explore a risk-based framework for validating generative AI in GxP systems. Learn how to meet 21 CFR Part 11 rules, ensure data integrity, and apply CSA princip

40 min read

10/28/2025

generative ai 21 cfr part 11 gxp computer software assurance data integrity pharmaceutical validation alcoa+life sciences fda compliance eu annex 11

Git Version Control for FDA and IEC 62304 Compliance

Examines how to apply Git version control workflows to satisfy FDA compliance, covering traceability, audit trails, and standards like 21 CFR Part 11 & IEC 62304.

50 min read

8/26/2025

git fda compliance version control iec 62304 21 cfr part 11 medical device software regulatory submission traceability

21 CFR Part 11: Electronic Records, Signatures, AI, GxP Compliance

Explore 21 CFR Part 11 compliance for electronic records, signatures, and AI in GxP. Covers key elements, FDA guidance, and controls for data integrity and audit-ready systems.

60 min read

7/25/2025

21 cfr part 11 fda compliance gxp electronic records electronic signatures artificial intelligence data integrity regulatory affairs quality assurance system validation