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 4.3.8: Operation: Record Management

What does 4.3.8 require?

GxP records and data are retained for the defined retention period in a form that keeps their content and meaning, including electronic signatures, audit trails and other metadata, and archiving and retrieval processes move records to secure storage where they are safe from being reached, changed or erased without authority or by accident, and remain readily retrievable for business and regulatory purposes. The archiving approach is considered at system design, roles and procedures are defined, archived records are checked initially and periodically for accessibility, durability, readability and completeness, and archiving is distinguished from backup, as detailed in Appendix O13.

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.

FDA 21 CFR Part 11 · 1 control

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.