A single methodology that produces a working system and a complete validation package as one set of artifacts. Five phases. Senior practitioners only.
The configurators and the validators are the same people. There is no handoff from "build" to "validate." The traceability matrix is maintained from day one.
We do not validate every feature to the same depth. We classify by patient-safety, product-quality, and data-integrity risk per FDA's 2025 CSA guidance and GAMP 5 Second Edition — then size the protocol accordingly.
Every configuration decision has a written rationale linked to a user requirement. Every test has a written acceptance criterion linked to a functional requirement. Every deviation has a written justification reviewed by quality.
Each phase produces named, contractually-defined artifacts. Acceptance is binary. Phase boundaries are decision points: the work that's done is reviewed and signed off before the next phase begins.
Stakeholder interviews, process mapping, user requirements specification, risk assessment, validation plan, project plan. The phase ends with an approved scope and a signed validation plan.
Functional requirements specification, configuration specification, integration architecture, and the first version of the traceability matrix. By the end of this phase, every requirement is linked to a configuration decision and a planned test.
Configuration, integration development, data migration design, IQ protocol execution, end-user training development. The system is built, qualified at the installation layer, and ready for verification testing.
OQ protocol execution, PQ protocol execution, user acceptance testing, training delivery. The traceability matrix closes; every requirement is tied to a passed test.
Cutover, hypercare, validation summary report, transition to managed services. The system is live, validated, and ready for inspection.
Tell us what's in flight. We'll respond personally — usually within a business day.