Built for Class II & III device OEMs and CDMOs, where every change, every CAPA, and every complaint has to stay traceable across functions.
Trusted by FDA-regulated device teams
Incumbents track document status. Unifize reconstructs the decision trace across every function a change touched.
The reconstruction always lands on someone. Find your seat, and the record you answer for.
Owns release confidence, and answers for the trace when the investigator is in the room.
Owns change velocity, and the rationale that has to survive the next revision.
Owns the submission and label trail, under deadlines someone else sets.
Owns the validated state, from the EO cycle a change touches to the system that records it.
Owns whether decisions move at all, and signs for the cost when they don't.
Each runs as a Unifize solution with the device regulations built in. Start with the one that costs you most.
From the first seal complaint on line 2 to the change that fixes it, and an effectiveness check that holds.
One change carried to every document, approval and training record it touches.
The pouch supplier's material change and the sterilizer's agreement, worked across the boundary, not through an inbox.
The seal breach complaint from awareness date to filed report, with the reportability reasoning kept.
Unifize sits alongside the QMS, ERP, PLM, and LIMS you have already validated. It replaces the ungoverned channels (email, meetings, spreadsheets) where the decision trace goes missing, not your systems of record.
Every approval is captured as a Part 11 electronic signature, attributable and time-stamped, so the decision trace is the audit trail, not a reconstruction after the fact.
IQ/OQ/PQ, audit-trail integrity and ALCOA+ posture, and security review are walked through with your CSV team in a validation review, before anything touches a regulated record.
Statutory deadlines, not customer outcomes. Each one routes to the process that answers it and the team that owns the response.
Routes to Complaint / MDR Reporting · owned by Regulatory Affairs
Routes to Recall Execution · owned by Quality / RA
Routes to CAPA & Effectiveness · owned by Quality
$0.9Mto$10M
Short, candid accounts of change control, the DHF, and FDA audits from the engineers and quality leads doing the work.
Harmonic BionicsClarissa ArcherChanges that took three weeks now take a couple of days
Harmonic BionicsMichael Hogan, Mechanical EngineerA print change released and with purchasing the same day
Jarod MarkleyMedical DevicesFull design history, one click from the device
Jarod MarkleyMedical DevicesOut-of-tolerance calibrations open an NC automatically
Harmonic BionicsClarissa ArcherFDA questions answered from the full audit trail
Harmonic BionicsDenis MachokaMaterial with an open issue flagged before use
Harmonic BionicsDenis MachokaSuppliers reply inside Unifize, no emails involvedPick a decision you could not replay at the last audit, a sterilization change, a seal complaint or the CAPA behind it, and we will reconstruct it live in a 30-minute walkthrough.
