Capture what's out of spec the moment it's found — not the moment it's remembered.
Nonconformance Management gives operators, analysts and QA a single place to record out-of-spec material, process output or environmental results at the point of discovery, then routes disposition and root cause straight into CAPA — so nothing waits for someone to write it up later.
Built around how a nonconformance actually gets investigated.
Nonconformance handling isn't its own regulation so much as the trigger for several — the record you keep here is the one an investigator asks to see first.
Production Record Review
Requires any unexplained discrepancy in a batch to be investigated and the investigation extended to other batches that may be associated. A nonconformance record is the documented starting point of that investigation.
Complaint Files
Complaint handling shares the same discipline as nonconformance capture — a written record, an evaluation of whether an investigation is warranted, and a documented conclusion.
Nonconforming Product
For device and combination-product manufacturers, requires documented procedures to identify, evaluate, segregate and disposition nonconforming product — the direct basis for this module's workflow.
Quality Risk Management
Calls for disposition decisions — use as-is, rework, or reject — to be made on a documented, risk-based assessment rather than ad hoc judgment.
What changes when nonconformance capture is a workflow, not a form.
The record still needs a human decision. The software's job is to make sure that decision is fast, consistent and never loses its evidence trail.
Capture at the point of discovery
Log a nonconformance from the floor, the lab, or a mobile device the moment it's found — no waiting for a shift-end form or a walk back to a workstation.
One click into CAPA
Promote a nonconformance to a CAPA without re-typing anything — the description, evidence and root-cause notes carry over automatically.
Risk-based disposition, applied consistently
A built-in scoring model guides the use / rework / reject decision so two similar nonconformances don't get two different outcomes.
Recurring problems surface on their own
Nonconformances roll up by product, line, and root cause automatically, so a pattern shows up in a trend chart before it shows up in an inspection finding.
See nonconformance-to-CAPA in your own environment.
We'll walk through how a nonconformance opened on your floor becomes a linked, evidenced CAPA record — using your own product lines and forms.