21 CFR Part 11 & Annex 11 Compliance

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…

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…

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…

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…

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.…

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…

How to Ensure Data Integrity in Electronic Systems

How to Ensure Data Integrity in Electronic Systems How to Ensure Data Integrity in Electronic Systems The validation of electronic systems is a critical aspect of ensuring compliance in the pharmaceutical industry. This comprehensive guide outlines the step-by-step process involved…

Annex 11 Compliance Strategy for EU-Based Pharma Facilities

Annex 11 Compliance Strategy for EU-Based Pharma Facilities Annex 11 Compliance Strategy for EU-Based Pharma Facilities The validation of computerized systems is an essential component in ensuring compliance with regulatory requirements in the pharmaceutical industry. Notably, compliance with Annex 11…

Requirements for User Access Controls in Part 11 Systems

Requirements for User Access Controls in Part 11 Systems Requirements for User Access Controls in Part 11 Systems User access controls are critical components of compliance with 21 CFR Part 11, which governs the use of electronic records and signatures…

Time Stamp Synchronization and Record Authenticity

Time Stamp Synchronization and Record Authenticity Time Stamp Synchronization and Record Authenticity Validation in pharma companies is an essential aspect of ensuring compliance with regulatory standards. This article provides a detailed, step-by-step tutorial on the critical components of validation, focusing…