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 4.2.5.5: 4.2.5.5 Documentation Management and Knowledge Management

Information created during the project, whether in documents or as records within tools, is managed so that it is produced, reviewed, approved where needed, issued, changed, withdrawn and stored under control, is searchable and retrievable when needed, and demonstrates that the system is in a state of control; documents are not created for their own sake. Knowledge management ensures that the understanding gained during the project, including the implicit knowledge of the project team and lessons learned, is transferred to the operational and support organizations and preserved for the life of the system, as detailed in Appendix M9.

Maintained by Gerard BlokdykControl text last updated

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

  • 4.2.4 Control of documents

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.