FAT and SAT evidence pack for a tube-in-tube sterilizer

Freeze the configuration under test

List equipment identification, drawing and software revisions, materials, instruments, included pumps and the simulated downstream connection. Link each test to the purchase scope and acceptance criterion.

Separate workshop and site checks

FAT can document the assembled scope, dry/water functions, alarms and records within the agreed workshop boundary. SAT must also verify installed utilities, connections, instrument state, interlocks and the real line arrangement. State when a test is simulated.

Keep product validation explicit

A signed machine FAT is not a shelf-life or commercial-sterility result. Name the product and package verification still required, deviations, responsible reviewer and closure evidence. The downloadable worksheet is blank; no customer project or completed FAT is claimed.

Prepare the record and the equipment scope

Download the blank data sheet, scope matrix and RFQ checklist. Record missing values as unknown. The worksheet contains no measured results.

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