DMS
12 min read
January 26, 2026
GxP-Compliant DMS - Document Management in Life Sciences
Dr Anna Kowalska
Quality & Compliance Director
Key Takeaways (TL;DR)
Executive Summary
DMS must provide full version control and change history
Electronic signatures require validation per 21 CFR Part 11
Document retention policy must comply with regulatory requirements
A Document Management System (DMS) in life sciences must meet rigorous GxP requirements (GMP, GLP, GCP). Key features include version control, approval workflows, electronic signatures compliant with 21 CFR Part 11, and complete audit trails.
Frequently Asked Questions (FAQ)
How long to retain GxP documentation?
Retention period depends on document type - typically minimum 15 years for manufacturing documentation, even longer for clinical trial records.
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