Tag: pharma validation

How to Validate Audit Trail Functionality in Pharma Systems

How to Validate Audit Trail Functionality in Pharma Systems How to Validate Audit Trail Functionality in Pharma Systems In the ever-evolving landscape of the pharmaceutical industry, ensuring data integrity and compliance with regulatory requirements has become paramount. A critical component…

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…

Utility System Qualification: What FDA Inspectors Look For

Utility System Qualification: What FDA Inspectors Look For Utility System Qualification: What FDA Inspectors Look For Utility System Qualification is a crucial aspect of pharma validation within the pharmaceutical industry. It ensures that utility systems, which are essential to the…

Testing Minimum Requirements for Legacy Qualification

Testing Minimum Requirements for Legacy Qualification Testing Minimum Requirements for Legacy Qualification Legacy equipment poses unique challenges in the pharmaceutical validation landscape, particularly in adhering to regulatory compliance and maintaining product quality. This comprehensive guide aims to equip QA, QC,…

What Is CPV in Pharma? Full Guide to Stage 3 Validation

What Is CPV in Pharma? Full Guide to Stage 3 Validation What Is CPV in Pharma? Full Guide to Stage 3 Validation In the ever-evolving landscape of the pharmaceutical industry, ensuring a consistent and quality product through rigorous validation processes…

Executing Stage 2 PPQ: Checklist for Compliance

Executing Stage 2 PPQ: Checklist for Compliance Executing Stage 2 PPQ: Checklist for Compliance In the pharmaceutical industry, ensuring consistent product quality and regulatory compliance is paramount. Stage 2 of the process validation lifecycle, known as Process Performance Qualification (PPQ),…