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Quality management software for the nonconformance and the fix

Quality systems stall when the nonconformance, the corrective action, and the project that caused them are three databases. Sigmaviu keeps NCR and CAPA in the quality hub, with industry packs you can apply or remove as a set.

Quality managers and regulated-project leads.

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Quality · NCR / CAPA

Live
A nonconformance moving through corrective action and a check that it worked.

Quality loop

NCR

What broke

7 open

CAPA

The fix

3 due

Verify

Did it hold

92%

A person closes the loop — nothing auto-closes

A nonconformance moving through corrective action and a check that it worked.

What changes

  1. 01

    The loop is visible

    Nonconformance, action, and follow-up stay linked.

  2. 02

    Packs for the industry you are in

    Apply a healthcare, automotive, public-sector, or similar pack, and remove it as a set if it does not fit.

  3. 03

    Evidence for the audit

    Quality records can be suggested against controls and exported with the rest of the file.

Snapshot

NCR / CAPA board

Operational quality — not certified auditor output

Sample
RecordTypeStatusDue
NCR-118NCROpenFri
CAPA-042CAPAIn fixNext week
NCR-101NCRVerifyingToday
CAPA-033CAPAClosed—

Distribution

Open28%
In fix34%
Closed38%

How Sigmaviu handles this

Project context

The work that failed can point at the project and the documents that define the requirement.

Getting started

The hub opens with a guide that marks steps done from real records, not a tour you dismiss forever.

Change control

Product and project changes remain their own records, so a CAPA does not pretend to be an engineering change.

Training

Training completion can support the same evidence story when a control asks who was qualified.

A working sequence

  1. 1

    Log the break

    Open the nonconformance with the evidence.

  2. 2

    Assign the action

    Name the corrective and preventive work.

  3. 3

    Check it

    Record whether the action held.

  4. 4

    Show it

    Include the closed record in the evidence pack.

Scope

Industry packs configure the quality hub. They do not certify you to ISO 13485, IATF 16949, or any other standard.

Questions buyers ask

Can we turn a pack off?

Yes. Apply and remove packs as a set so you are not deleting rows by hand.

Does a CAPA change the product design?

A CAPA is a quality record. Product structure and engineering changes live in the product lifecycle records when you use them.

Will this map itself to ISO 9001?

Suggestions can be generated for a person to apply. The mapping is not filed until then.

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