Undeclared allergen · ingredient lot
Traceback · FSMA 21 CFR 117 · HACCP
Built for mid-market food manufacturers, co-packers, and contract manufacturers under FSMA preventive controls and a GFSI scheme, where every deviation, allergen-control record, and hold decision has to stay traceable across food safety, operations, and supplier quality, and survive a surveillance audit or a recall.
Built for FSMA-regulated, GFSI-certified food makers
Incumbents track a status field. Unifize reconstructs the decision trace across every function a deviation touched: the corrective action, the verification, and the reasoning an auditor actually asks for.
The reconstruction always lands on someone. Find your seat, and see what you own when the trace has to hold up at a GFSI surveillance audit or an FDA recall.
Every deviation, corrective action, and release decision stays reconstructable.
Cross-functional hold and disposition decisions move on one accountable thread.
Allergen statements, label claims, and Reportable Food Registry obligations stay current and traceable.
HACCP validation, environmental monitoring, and audit findings are captured where they happen.
Recipe and formulation changes move fast with their hazard analysis and validation sealed to the record.
Each runs with FSMA, HACCP and your GFSI scheme built in. Start with the one that costs you most.
From the deviation on the line to a corrective action closed before the next surveillance audit.
COAs and letters of guarantee checked against spec and tied to the lot they cleared.
Environmental monitoring and allergen swab positives, and the holds they force, decided on a trail, not an escalation call.
Recall, mock recall and the RFR decision coordinated as one event under the clock.
Unifize sits alongside the ERP, QMS, LIMS, and EHS you already run, and replaces the ungoverned channels where the corrective-action trace goes missing. Many manufacturers still run these processes on spreadsheets today; Unifize lands there without a full system displacement.
Every approval is captured as an attributable, time-stamped electronic signature, so the decision trace is the audit trail a GFSI surveillance audit or a retailer program asks for, not a reconstruction assembled the week before.
Food safety plan control, corrective-action rigor, supplier verification depth, and environmental-monitoring posture are walked through with your team before anything touches a controlled record.
Statutory and customer deadlines, not internal outcomes. Each one routes to the process that answers it and the team that owns the response.
Routes to Recall Plan & Mock Recall · owned by Food Safety / RA
Routes to COA & Letter of Guarantee · owned by Supplier Quality
Routes to GFSI Surveillance Readiness · owned by Food Safety / Audit
$0.4Mto$4.1M
Pick a deviation or corrective action you could not replay at the last audit. We will reconstruct it live.