Tag
Cfr Part 11
3 articles
Compliance frameworks
Computer system validation for SaaS
Who validates a SaaS system under FDA rules, which documents each side owns, and how to keep validation current when the vendor ships changes every month.
6 min read
Compliance frameworks
Part 11 audit trails and electronic signatures
What 21 CFR 11.10(e), 11.50, 11.70 and Subpart C ask of audit trails and e-signatures, how they meet SSO and MFA, and the design errors that fail review.
7 min read
Compliance frameworks
21 CFR Part 11 explained
What FDA's Part 11 covers, how predicate rules decide whether it applies to your records, and which controls the FDA's 2003 scope guidance still enforces.
7 min read