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 4.2.5.3: 4.2.5.3 Design Review

Design reviews are systematic, planned examinations of specification, design and development deliverables against standards and requirements, performed by subject matter experts at suitable points in the life cycle to identify issues and propose corrective actions, and they are part of verification. Their rigor is based on risk, complexity and novelty: regulated company design review is typically not required for standard products, focuses on configuration and customization for configured products, and is performed at each level of specification or within each sprint for custom applications, with the supplier's own reviews verified during supplier assessment.

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What else in your programme already covers this

This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

ISO 13485:2016 · 1 control

  • 7.3.5 Design and development review

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

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

Query this from an agent

The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.