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 2.1.3: 2.1.3 Scalable Life Cycle Activities

Life cycle activities are scaled to how far the system affects patients, product quality and the integrity of data, to its complexity and novelty, and the outcome of the supplier assessment, so that a simple, low-impact system carries far less documentation and verification than a complex, high-impact custom application. Scaling applies to the rigor of specification, the depth of design and code review, the extent of testing and the formality of records, and it is a positive duty: unnecessary activities and records add cost without adding assurance, and the rationale for the scaling chosen should be documented so it can be explained to a regulator.

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.

FDA 21 CFR Part 11 · 1 control

  • Part11.CSV Computer system validation + risk-based approach (21 CFR §11.10(a) + 2003 FDA Scope and Application Guidance + 2023 CSA draft)

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.