GAMP 5 - Good Automated Manufacturing Practice
Chapter 7: Supplier activities (products, applications, services and the supplier good practices) – GAMP 5 - Good Automated Manufacturing Practice

GAMP 5 - Good Automated Manufacturing Practice 7.13: System Support and Maintenance During Operation

What does 7.13 require?

The supplier supports and maintains the system as the agreed contracts require, working to formal procedures that usually cover: change control in operation; configuration and patch management; incident management; managing documentation; backup and restore; business continuity and disaster recovery; handling releases of the software product; training the supplier's own staff; maintaining the system; and managing security. The guide's operational sections and appendices describe each of these.

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.

  • 6.1 6.1 Establish software maintenance plan

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 7: Supplier activities (products, applications, services and the supplier good practices) – 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.