GAMP 5 in Practice
Scalable lifecycle assurance for GxP computerized systems
ISPE GAMP 5 Second Edition provides a risk-based framework for computerized systems that are effective, fit for intended use, and compliant with applicable GxP requirements. It emphasizes critical thinking by knowledgeable subject-matter experts and scalable assurance across modern technology and service models.
A practical lifecycle approach:
• Define intended use, process context, regulated impact, and system boundaries.
• Apply quality risk management from concept and selection through operation and retirement.
• Assess suppliers and leverage suitable vendor activities, knowledge, and evidence.
• Scale specifications, testing, traceability, and review to risk, novelty, and complexity.
• Maintain the validated state through controlled configuration, change, incidents, security, backup, periodic review, and retirement.
GAMP 5 is guidance—not a regulation. Organizations should align their approach with applicable laws, internal procedures, product risk, and the evidence needed to support confident decisions.