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1. Description and scope

States what is changing, from what to what, by document, equipment or system identifier
States why the change is being made and what it is meant to achieve
Lists every product, system, site and process the change touches; 'this one only' carries a rationale
Change was raised before any implementation began (no retrospective raising)

2. Classification

Quality class (like-for-like, minor, major) assigned on what the change could affect, not on the size of the job
Rationale for the class documented in terms of quality attributes, validated state and registered particulars
Any like-for-like claim supported by a documented equivalence check by someone other than the requester
Emergency route, if used, recorded at the time with the full assessment completed within the defined period

Assessed by regulatory affairs against the current dossier, citing the section compared, for every market supplied
Variation category stated (Type IA, IA IN, IB or II under Regulation (EC) 1234/2008; substantial change notified to the notified body for devices)
Implementation constraint that follows from the category written on the record
Marketing authorisation holder or customer notified where a quality agreement requires it

Validation and qualification: affected protocols and reports named; scope of requalification or revalidation defined or rationale for none
Product quality and stability: affected attributes named; stability or comparability plan defined where needed
Cleaning: product-contact changes assessed against cleaning validation
Analytical: methods, specifications, reference standards and laboratory systems assessed by QC
Supply, materials and suppliers assessed, including inventory of the old version
Documentation and training: every affected document listed; people to be trained identified
Every 'no impact' cites what was checked; each area answered by the function that owns it

All gating actions complete with evidence attached or referenced before go-live approval
Documents at their approved new revision before first use
Training completed and recorded before first use
Regulatory status permits use in each market, and batches made in any waiting period are controlled
Last batch on the old state and first batch on the new state identified

What was implemented compared to what was approved (part, value, version, revision) by someone other than the implementer where practical
Any difference between approved and implemented triggered a revised assessment before proceeding
For computerised systems, audit trail extract attached and reviewed; regression testing scope followed the risk assessment

Data gathered as defined in the plan, over the full window
Result compared to the criterion; unintended effects considered
Conclusion written with evidence; failure leads to a further change, CAPA or reversal, not a signature
Any waiver of the check recorded with a reason