GAMP 5 - Good Automated Manufacturing Practice
Chapter 6: Regulated company activities (governance and system-specific activities) – GAMP 5 - Good Automated Manufacturing Practice

GAMP 5 - Good Automated Manufacturing Practice 6.2.8: Development and Review of Software for Custom Applications

What does 6.2.8 require?

The regulated company need not review the code of software products that are standard or configurable. Bespoke applications, and bespoke software added to configured products such as interfaces, macros and report generation, are built to defined standards, and whether new software is reviewed during development, and how deeply, is decided by risk, complexity and novelty. A suitable subject matter expert, usually from the organisation doing the development, carries out the reviews, and the regulated company makes sure the resulting corrective actions are followed through to a satisfactory close, as Appendix D4 explains.

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.

  • 5.5.2 5.5.2 Establish software unit verification process

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 6: Regulated company activities (governance and system-specific activities) – 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.