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SOP-QA-015Version 4.0Effective 2026-01-12Owner: Quality AssuranceEffective

Change Control

Fictional document for the demonstration.

Version history

Version 5.0Scheduledstarts 2027-01-15
Version 4.0Effectivesince 2026-01-12

§3.1 Scope

All changes to validated systems, processes, equipment, materials and documents are assessed under change control before implementation.

§3.2 Pre-approved categories

A like-for-like replacement of a certified part with an identical specification, carried out in a planned maintenance window with no process impact, is a pre-approved change category and needs only QA acknowledgement.

§4.4 Risk-based review

Any change that is not like-for-like is risk assessed under ICH Q9(R1). The formality of the review must be commensurate with the risk level.