Tag: 21 CFR Part 11 & Annex 11 Compliance

Understanding Audit Trail Review Frequency and Retention

Understanding Audit Trail Review Frequency and Retention Understanding Audit Trail Review Frequency and Retention In the realm of pharmaceutical validation, maintaining the integrity of data generated by automated systems is paramount. This article focuses on the critical aspect of audit…

21 CFR Part 11 Checklist for Computer System Validation

21 CFR Part 11 Checklist for Computer System Validation 21 CFR Part 11 Checklist for Computer System Validation The validation lifecycle within the pharmaceutical industry is crucial to ensuring that processes and systems meet regulatory requirements and maintain quality standards.…

Compliance Requirements for Electronic Records in GMP Systems

Compliance Requirements for Electronic Records in GMP Systems Compliance Requirements for Electronic Records in GMP Systems In the pharmaceutical and biologics industries, ensuring compliance with regulatory guidance is critical, particularly when it comes to the use of electronic records. This…

How to Validate Electronic Signatures and Audit Trails

How to Validate Electronic Signatures and Audit Trails How to Validate Electronic Signatures and Audit Trails In today’s highly regulated pharmaceutical and medical device industry, ensuring compliance with electronic records is paramount. This comprehensive guidance details a step-by-step process for…

Annex 11 vs 21 CFR Part 11: Key Differences and Overlaps

Annex 11 vs 21 CFR Part 11: Key Differences and Overlaps Annex 11 vs 21 CFR Part 11: Key Differences and Overlaps In today’s highly regulated pharmaceutical and medical device landscape, understanding the differences and overlaps between regulatory frameworks is…

What Is 21 CFR Part 11? A Complete Guide for Pharma QA

What Is 21 CFR Part 11? A Complete Guide for Pharma QA What Is 21 CFR Part 11? A Complete Guide for Pharma QA Step 1: Understanding the User Requirements Specification (URS) & Risk Assessment Before embarking on the commissioning…