CHANGE CONTROL RECORD 21 CFR Part 11 Compliant

System Changelog

Authoritative record of all system changes with validation impact classifications. Each release includes GxP assessment data for change control and impact analysis.

High impact
Medium impact
Low impact
No validation impact
v0.9.0 Pre-release / Development High Validation Impact

Initial implementation of GxPSign, establishing the core SaaS PDF e-signature platform for GxP (GAMP5 Category 4) and Freelancer/SMB markets. This release includes multi-tenant architecture, electronic signature workflows, audit logging, and GxP qualification documentation framework.

GxP Use: This changelog is the authoritative record for Change Control and Impact Assessment in regulated environments. Validation impact classifications follow GAMP5 Category 4 software guidelines. Each "High" impact release requires OQ/PQ re-execution for affected functionality.

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Every release ships with updated qualification documentation.