Templates
Battle-tested protocol and deliverable templates for validation programmes.
A template is a document structure you can start from rather than design — protocol sections, the fields each one needs, and the acceptance criteria that make a test capable of failing. Ours cover the IQ, OQ and PQ protocols and reports, with the stage set scaled to the system's GAMP category and its functional risk.
Why templates quietly shape what you test
A protocol template that only accommodates scripted steps will enforce scripted testing forever, whatever your policy says. This is the single most common reason a CSA transition produces no reduction in effort — the SOP was updated and the templates were not.
Templates that make room for unscripted testing with a session record, and for assessed supplier evidence, are what let a risk-based approach actually reach the page.
Scaled, not maximal
A Category 3 non-configured product does not need the Operational Qualification depth a Category 5 bespoke system demands. The templates indicate which sections apply at which category so the scaling decision is visible rather than left to whoever is drafting at the time.
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