Every non-conformance, linked to its corrective action

Raise an NCR with a description, source, severity and disposition, then link it to a CAPA with an owner, a due date and an effectiveness check. Nothing closes without evidence, and nothing falls through the cracks.

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Part of OpSemble Quality (QMS): £7 per user per month on top of the £29/month platform fee. 14 days free, no card required.

What you get

Non-conformance reports

Raise NCRs with severity, source (internal, supplier, customer, audit), root cause and disposition. Investigate and close, with every step logged.

CAPAs with owners and dates

Corrective and preventive actions with a named owner, a due date, implementation evidence and a verification step before closure.

Effectiveness checks

A CAPA isn’t closed when the action is done. It’s closed when someone verifies it worked, and the system asks for that.

Raise from audit findings

Turn an internal or supplier audit finding into an NCR in one click, keeping the link from finding to action.

My actions

Everyone sees the NCRs and CAPAs they own, with due dates, so the quality manager stops being the person who chases.

ISO 9001 clause 10.2 evidence

The NCR-to-CAPA trail is exactly what clause 10.2 asks for, and each record can be linked to the ISO 9001 register as evidence.

How it works

Raise the NCR

What went wrong, where it came from, how bad it is, and what happens to the product or output.

Find the root cause

Investigate and record it. Disposition the non-conforming output.

Link a CAPA

Owner, due date, the action itself. Implement it and attach the evidence.

Verify effectiveness, then close

Check the action actually fixed the cause. Only then does the record close, with the full trail behind it.

NCR and CAPA software for ISO 9001 without the enterprise price tag

ISO 9001:2015 clause 10.2 asks for something simple: when a non-conformity occurs, react to it, evaluate the cause, take corrective action, and check the action worked. The spreadsheet version breaks at step four. Actions get marked done, nobody comes back to verify, and the same non-conformance turns up again at the next audit.

OpSemble makes the loop structural. An NCR can’t be quietly closed; it’s linked to a CAPA with an owner and a due date, and the CAPA has an effectiveness check as its final step. Every transition is logged with who, what and when. When the auditor asks for evidence of corrective action, you filter the register instead of reconstructing it.

Non-conformances arrive from everywhere: an internal audit finding, a supplier delivery, a customer complaint, a health and safety incident. All of those can raise an NCR in OpSemble, including a finding from an audit in the same module and an incident from the Health & Safety module, which is what an integrated management system looks like in practice.

Enterprise eQMS platforms do all this, priced for pharma. OpSemble Quality is £7 per user per month on top of a £29 platform fee, alongside document control, audits, approved suppliers and an ISO 9001 clause register, with a 14-day free trial and no card required.

Frequently asked questions

What is the difference between an NCR and a CAPA?

An NCR records that something didn’t meet requirements: the what, where and how bad. A CAPA is the action taken to remove the cause so it doesn’t happen again. In OpSemble an NCR is linked to one or more CAPAs, and the CAPA carries the owner, due date and effectiveness check.

Can an NCR be raised from an audit finding?

Yes. Findings from internal and supplier audits can be turned into NCRs in one click, keeping the link between the finding and the action.

Can a health and safety incident become a CAPA?

Yes. Incidents in the Health & Safety module can drive corrective actions in Quality, so the two systems share one improvement loop.

What is an effectiveness check?

The final step of a CAPA: someone verifies that the action removed the cause. OpSemble asks for it before the CAPA closes, which is what ISO 9001 clause 10.2 expects.

Can I record supplier non-conformances?

Yes. Set the source of an NCR to a supplier, and it sits alongside the supplier’s approval status and quality ratings in the approved supplier register.

What does it cost?

Quality (QMS) is £7 per user per month, on top of the £29/month platform fee. 14-day free trial, no card required.

Close the loop on the next non-conformance

Quality (QMS) is one switch in your OpSemble tenant. Raise your first NCR in the trial and see the CAPA chase itself.

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