GAMP 5 - Good Automated Manufacturing Practice
Chapter 8: Efficiency improvements – GAMP 5 - Good Automated Manufacturing Practice

GAMP 5 - Good Automated Manufacturing Practice 8.1: Establishing Verifiable and Objective User Requirements

What does 8.1 require?

Requirements are analysed to ensure they are fully defined, verifiable and objective, with the depth of detail set by how new and complex the process and system are; an incomplete requirement such as a room controlled at a temperature becomes complete when the tolerance and permitted excursions are stated. Developing such requirements draws on process knowledge, business knowledge to challenge requirements against need, ownership, analytical challenge for completeness and accuracy, technical and product knowledge for practicality, identification of process and product impact including CQA and CPP relations, and technical authorship in concise, correct, unambiguous language.

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.

  • 5.2.6 5.2.6 Verify software requirements

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 8: Efficiency improvements – 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.