Method

Five phases.
One deliverable each.

Each phase closes with a document the client approves.

Process analysisCurrent process and applicable regulatory obligations.Process map

SpecificationUser requirements, approved before development.URS

DevelopmentIterative releases in a test environment the client can access.Working versions

ValidationPackage approved by the client before go-live.VMP · IQ/OQ/PQ

OperationMaintenance by the development team, periodic review.Change log · Review

Who does what.

Intended useApproves URSApproves validation

Process analysisProject directionRegulatory expertiseValidation oversight

DevelopmentTestingIQ/OQ/PQMaintenance

Validation references · proportionate to intended use and risk.

GAMP 5CSAEU GMP Annex 1121 CFR Part 11