News
Product updates and announcements from Tracidor.
September 28, 2026
EU GMP Annex 11 is getting its first rewrite in 14 years — here's what's changing
The EU's core rulebook for computerised systems hasn't been touched since 2011. The 2026 revision adds explicit AI/ML provisions, tamper-proof audit trails, and tighter cloud oversight — and PIC/S carries it into 50+ countries.
September 17, 2026
From CSV to CSA: what FDA's final guidance actually changes for validation teams
FDA's Computer Software Assurance guidance reached its final, QMSR-aligned form in February 2026. Here's what the shift to risk-based validation actually means day to day.
September 17, 2026
Tracidor is live
Every requirement, traced to a test that was actually signed off — whether you're running standard delivery or full GxP validation.