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 6.2.2: 6.2.2 Identify System

The system is assessed to establish whether GxP regulation applies to it, and is entered to the inventory of computerized systems in accordance with documented procedures, so that it is known, owned and scheduled into the compliance framework from the start of the project. The GxP determination is recorded with the specific regulations and the parts of the system to which they apply, since a system that is only partly in scope of GxP can be validated far more simply once that is understood.

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

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.