computerized systems – Pharma GMP

SOP for Audit Trail Review of Computerized Systems

digi — Tue, 25 Nov 2025 23:45:04 +0000

SOP for Audit Trail Review of Computerized Systems: Comprehensive Step-by-Step Guide Step-by-Step Guide to Developing and Implementing an Audit Trail Review SOP In pharmaceutical manufacturing and quality systems, computerized systems are subject to stringent regulatory controls to ensure data integrity, patient safety, and product quality. One of the core components of maintaining compliance with regulations...

Never Rely on Electronic Signatures Without System Validation

digi — Wed, 20 Aug 2025 19:59:43 +0000

Never Rely on Electronic Signatures Without System Validation Don’t Use Electronic Signatures Unless Systems Are Validated Remember: Electronic signatures must only be used on GMP records if the system has been validated for compliance with applicable regulations like 21 CFR Part 11. Why This Matters in GMP Electronic signatures have become standard in modern GMP...

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...