Tag: Computer System Validation (CSV)

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…

GAMP 5 Category 3 vs Category 5: Validation Effort Comparison

GAMP 5 Category 3 vs Category 5: Validation Effort Comparison GAMP 5 Category 3 vs Category 5: Validation Effort Comparison 1. Understanding User Requirements Specification (URS) and Risk Assessment The foundation of any validation effort begins with a thorough User…

Role of IT and QA in GAMP 5-Based System Validation

Role of IT and QA in GAMP 5-Based System Validation Role of IT and QA in GAMP 5-Based System Validation In the pharmaceutical industry, validation of computer systems is critical to ensure compliance with regulatory requirements and to maintain quality…

Training Your Team on GAMP 5 Principles and Practices

Training Your Team on GAMP 5 Principles and Practices Training Your Team on GAMP 5 Principles and Practices This article provides a comprehensive step-by-step guide for pharmaceutical professionals on the principles and practices of GAMP 5, specifically focusing on the…

GAMP 5 Annexes: How to Use Them Effectively

GAMP 5 Annexes: How to Use Them Effectively GAMP 5 Annexes: How to Use Them Effectively In the pharmaceutical and biotechnology industries, adherence to regulatory requirements is crucial. The GAMP 5 guidelines provide a framework for ensuring that computer systems…

Challenges in Implementing GAMP 5: Real-World Case Studies

Challenges in Implementing GAMP 5: Real-World Case Studies Challenges in Implementing GAMP 5: Real-World Case Studies In the rapidly evolving landscape of pharmaceutical manufacturing, adherence to Good Automated Manufacturing Practice (GAMP 5) while ensuring compliance with regulations like FDA and…

Creating a GAMP 5-Compliant Validation Master Plan

Creating a GAMP 5-Compliant Validation Master Plan Creating a GAMP 5-Compliant Validation Master Plan In the landscape of pharmaceutical validation, compliance with regulations and guidance documents is a high priority. Validation Master Plans (VMPs) are essential for ensuring that all…