How many controls does ISPE GAMP 5 have?

ISPE GAMP 5 contains 17 controls organized across 4 domains.

Where does ISPE GAMP 5 apply?

ISPE GAMP 5 is applicable in International (ISPE). Organizations operating in or serving customers in this jurisdiction should evaluate its requirements.

What frameworks does ISPE GAMP 5 map to?

ISPE GAMP 5 has control-to-control mappings with 402 other compliance frameworks in our database. Use our compliance platform to explore these mappings interactively.

How do I get started with ISPE GAMP 5 compliance?

Start by understanding the framework's key controls and domains. Our compliance platform provides AI-powered gap analysis and mapping tools to help you assess your current posture and build a remediation plan.

ISPE GAMP 5 — A Risk-Based Approach to Compliant GxP Computerised Systems

GAMP 5 (Good Automated Manufacturing Practice, 2nd Edition 2022) is an industry guideline published by ISPE (International Society for Pharmaceutical Engineering). It provides a risk-based approach to the validation and management of computerised systems in the regulated life sciences industry.

Domains

Operation and Data Integrity

Specification and Verification

Software Categories

Key Concepts and Life Cycle

Frequently Asked Questions

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