Articles tagged with “annex-11”

DocuSign in Pharma: A Guide to 21 CFR Part 11 Compliance

An analysis of how DocuSign is used for electronic signatures in pharma and life sciences. Learn how it can meet FDA 21 CFR Part 11 compliance with its modules.

45 min read

10/23/2025

docusign 21 cfr part 11 pharma compliance electronic signatures life sciences fda regulations gxp system validation annex 11

21 CFR Part 11: IT Guide to Electronic Records & Signatures

A detailed guide for IT on 21 CFR Part 11. Learn the FDA's rules for electronic records & signatures, including system validation, audit trails, & data integrit

45 min read

10/12/2025

21 cfr part 11 data integrity fda regulations electronic records electronic signatures computer system validation annex 11 audit trails

Navigating Regulatory Compliance in RTSM Systems for Clinical Trials

A comprehensive guide to regulatory requirements and best practices for implementing compliant Randomization and Trial Supply Management (RTSM) systems in clinical trials, covering FDA, EMA, and global standards.

55 min read

4/20/2025

clinical-trials rtsm irt regulatory-compliance fda ema gcp data-integrity validation audit-trails part-11 annex-11