GAMP 5 - Good Automated Manufacturing Practice
Chapter 4: Life cycle phases (concept, project, operation, retirement) – GAMP 5 - Good Automated Manufacturing Practice

GAMP 5 - Good Automated Manufacturing Practice 4.2.2: 4.2.2 Specification, Configuration and Coding

Specifications describe what the system will do and how it will do it at the level of detail the system needs: a requirements specification is always required, and functional, configuration and design specifications are added for configured products and custom applications according to risk, complexity and novelty. Configuration is performed and recorded against the configuration specification, custom code is developed to defined standards with design, development and review activities under a defined method, and the regulated company reviews and approves the specifications appropriate to its role, leveraging supplier specifications where the supplier has been assessed; specification records may be held in tools rather than documents.

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ISO 13485:2016 · 1 control

  • 7.3.4 Design and development outputs

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Other controls in Chapter 4: Life cycle phases (concept, project, operation, retirement) – GAMP 5 - Good Automated Manufacturing Practice

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