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 6.1.5: 6.1.5 Maintaining the System Inventory

The regulated company maintains an inventory of its computerized systems that records for each system its GxP status, its impact, its owners, its validation status and the key facts about it such as location, supplier and version, and the inventory is kept current through the life cycle so that systems can be identified for planning, periodic review, change management, inspection and retirement. Systems are added on identification, their GxP determination is recorded in accordance with procedure, and retired systems are removed or marked retired.

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 27002:2022 · 1 control

  • 5.9 Inventory of information and other associated assets

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

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