GAMP 5 - Good Automated Manufacturing Practice
Chapter 2: Key concepts (product and process understanding, life cycle within a QMS, scalable activities, science-based QRM, leveraging suppliers) – GAMP 5 - Good Automated Manufacturing Practice

GAMP 5 - Good Automated Manufacturing Practice 2.1.2: 2.1.2 Life Cycle Approach within a Quality Management System

Every computerized system is managed through a defined life cycle within the quality management system, covering the concept, project, operation and retirement phases, with activities that are systematic, planned, defined in procedures and scaled to the system. The guide positions the life cycle as the framework the QMS applies to computerized systems rather than a separate validation exercise, so that policies, roles, planning, verification, operational controls and retirement are all governed and evidenced under the same quality system, and supplier life cycles are recognized and leveraged where they have been assessed.

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.

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 2: Key concepts (product and process understanding, life cycle within a QMS, scalable activities, science-based QRM, leveraging suppliers) – 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.