Built for build-to-order machinery OEMs serving regulated end markets, where every engineering change, safety-critical design choice, and qualification record has to stay traceable across engineering, quality, and commissioning, and survive FAT, SAT, and the customer's audit.
Built for build-to-order machinery OEMs
Incumbents track the engineering change and the document status. Unifize reconstructs the decision trace across every function a change touched: the reasoning the customer's auditor and the technical construction file actually ask for.
The reconstruction always lands on someone. Find your seat, and see what you own when the trace has to hold up at FAT, SAT, and the customer's qualification audit.
Every NCR, corrective action, and punch-list decision stays reconstructable.
FAT, SAT, and commissioning decisions move on one accountable thread.
The technical construction file and declaration of conformity stay current and traceable to every safety-critical design choice.
IQ / OQ / PQ evidence and the customer-specific qualification package are assembled as they are generated and captured with an auditable e-signature.
Machine design changes and design FMEA decisions move fast with their rationale sealed to the record.
Each runs with CE marking, ISO 12100 and your customers' IQ / OQ / PQ built in. Start with the one that costs you most.
From the NCR on the build floor to a closed punch list the customer verifies.
Engineering change assessed for qualification impact before the cut-in.
Field modifications and service held against the unit they touch, for its life.
CE marking and the customer's IQ / OQ / PQ package assembled as it is generated.
Unifize sits alongside the PLM, ERP, CAD vault, and QMS you already run. It lands on engineering change management without an ERP or PLM displacement, and replaces the ungoverned channels where the decision trace goes missing.
Every approval is captured as an attributable, time-stamped electronic signature, so the decision trace is the audit trail: 21 CFR Part 11 where the equipment serves a regulated environment, and traceable to the technical construction file by construction.
IQ / OQ / PQ evidence, FAT/SAT documentation, engineering-change traceability, and the technical construction file are walked through with your team, and built to survive the customer's post-installation qualification audit.
Customer acceptance and conformity deadlines, not internal outcomes. Each one routes to the process that answers it and the team that owns the response.
Routes to FAT / SAT Execution · owned by Project & Build Operations
Routes to Customer Qualification (IQ / OQ / PQ) · owned by Qualification & Validation
Routes to Technical Construction File · owned by Compliance & CE Marking
$0.1Mto$1.3M
Pick an engineering change or a qualification package you could not replay at the last FAT, SAT, or customer audit. We will reconstruct it live.
