electronic data – Pharma GMP

GxP Data Integrity: Applying ALCOA+ to Electronic Systems

digi — Sat, 15 Nov 2025 09:14:47 +0000

GxP Data Integrity: Applying ALCOA+ to Electronic Systems Step-by-step Guide to Ensuring GxP Data Integrity by Applying ALCOA+ Principles to Electronic Systems Data integrity remains a cornerstone of pharmaceutical quality systems and regulatory compliance worldwide. With increasing dependence on GxP computerized systems to generate, store, and manage data, pharmaceutical and regulatory professionals must rigorously ensure...

Ensure Audit Trails Are Reviewed During GMP Quality Management Reviews

digi — Tue, 01 Jul 2025 21:01:58 +0000

Ensure Audit Trails Are Reviewed During GMP Quality Management Reviews Include Audit Trail Reviews in GMP Quality Management Activities Remember: GMP requires routine review of audit trails as part of Quality Management System (QMS) reviews to maintain electronic data integrity and accountability. Why This Matters in GMP Audit trails capture all activities within GMP electronic...