Software Services & Solutions

GAMP 5 Software Validation for GMP, GCP and GLP

Computerized systems are everywhere in life sciences, but the regulatory requirements surrounding them differ across manufacturing, clinical and laboratory environments.

So how do you build a validation approach that works across GMP, GCP and GLP?

This white paper explores the key requirements for computerized system validation across these three regulatory frameworks and shows how GAMP 5 can provide a consistent, risk-based approach to compliance.

About This White Paper

Computerized systems play a critical role in manufacturing, clinical trials and laboratory environments. Ensuring their reliability, data integrity and regulatory compliance requires navigating different sets of rules depending on whether your organization operates under GMP, GCP or GLP.

This white paper brings those requirements together in one practical overview. It explores key regulations and guidance including 21 CFR Part 11, EU Annex 11, ICH E6 and OECD GLP guidance, highlighting both their shared principles and their specific requirements.

More importantly, it explains how GAMP 5 can serve as a common framework for Computerized System Validation (CSV) across these environments. Through a structured, risk-based approach, GAMP 5 can help organizations design, validate, maintain and manage computerized systems while addressing the requirements of different regulatory frameworks.

Key Takeaways

✓ Understand the CSV Requirements Across GMP, GCP and GLP. Get a structured overview of the regulations and guidance governing computerized systems in manufacturing, clinical and laboratory environments, and understand where their requirements overlap and differ.

✓ Navigate 21 CFR Part 11 and EU Annex 11. Understand how the US and EU approaches differ, from electronic records and signatures under 21 CFR Part 11 to the broader risk-based quality management of computerized systems under Annex 11.

✓ Prepare for Computerized System Validation Under GCP. Explore the role of electronic records, data integrity and computerized systems in clinical trials, including the increased emphasis on computerized systems and data governance under ICH E6 (R3).

✓ Understand GLP Requirements for Computerized Systems. Learn how OECD guidance addresses validation and qualification, risk management, SOPs, data integrity, audit trails, access controls, change management and the lifecycle management of computerized laboratory systems.

✓ Apply a Risk-Based GAMP 5 Approach. See how GAMP 5 supports risk assessment, validation lifecycle management, documentation, change control, audit trails, security controls, training and supplier assessment.

✓ Build One Consistent Validation Approach Across GxP Environments. Discover how GAMP 5 can help reduce duplicated validation efforts and provide a scalable methodology across GMP, GCP and GLP, while still accounting for the specific requirements of each framework.

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