V5 Ultimate
Audits and CAPA

Audit findings that reach an owner and get closed.

Run audits from your own checklists, and send every finding to an owner with a clear path to closure.

Start your free trial Follow one audit

7-day free trial, no card required. Audits, CAPA and supplier scorecards are in Professional and Enterprise.

Auditor in hair cover, mask, safety glasses and gloves holding a tablet while talking with a supervisor in the same protective clothing beside production equipment

  • Your checklists.

    Internal and supplier audits run from the checklists you write, on a tablet or desktop.

  • Every finding owned.

    A person grades each finding under your rules; it then follows the path set for that grade.

  • Closed with evidence.

    Actions, effectiveness checks and sign-off stay linked to the finding for the next audit.

Follow one audit

AUD-2611 · goods-in internal audit · 15 of 18 lines passed

You confirm each grade. The follow-up opens.

Try it: you are the quality manager. Confirm each finding's grade to open its follow-up.

  • F-01Checklist line 6

    2 pallets, no certificate

    Your procedure suggests
    Major
  • F-02Checklist line 11

    Temperature log missing one day

    Your procedure suggests
    Minor
  • F-03Checklist line 14

    Quarantine sign faded

    Your procedure suggests
    Observation
0 of 3 findings confirmedFollow-ups open only after a person confirms.

Worked example. Grades follow your own audit procedure; V5 does not grade or escalate without a person.

How audits and CAPA work: checklists, grading, actions and close-out

Tap a step below to see what happens.

Step 1 of 5

AUD-2611 · Internal audit
Goods-in and receiving
  • ChecklistCL-REC-04 · rev F (in force)
  • AuditorR. Moreau
  • Area ownerWarehouse lead · P. Singh
  • Date14 Oct · 09:00

The checklist version in force is the one used.

Your checklist, your schedule

  • Choose the area, the checklist version and the auditor, as your audit procedure sets out.
  • Checklists are yours and can be kept under document control, so the version in force is the one used.

Audits need Professional or Enterprise. We do not supply certified industry checklist templates.

More on plan: full record and set-up

Also on this record

Last audit
April · 2 findings closed

Supplier audits use the same pattern, with responses gathered through the supplier portal where you use it.

Checklist wording
Where enabled, AI can suggest checklist lines from a scope you describe; the owner edits and approves them.
Document control
Checklists can be controlled documents with review and approval. Professional and Enterprise.
Audit types
Internal, supplier and other audits your procedures define.
Free buyer guide · 12 pages

Quality Management Buyer Guide

For quality, regulatory and operations teams choosing quality management software. Use it with or without V5.

  • 1Link audits, complaints and suppliers to traceability.
  • 2Set CAPA effectiveness criteria before you act.
  • 3Score suppliers on one of your own findings.
See what's inside
  • What to check in audit, complaint and supplier quality workflows, and how each should link back to traceability.
  • How deviations, out-of-spec results and CAPA connect, with effectiveness criteria defined before actions start.
  • Decision checklists, RFP questions and a scored sheet to compare systems on one of your real findings.

Chapters: why quality systems stall · from issue to closure · documents, revisions and training · deviations, out-of-spec results and CAPA effectiveness · audits, complaints, supplier quality and traceability · requirement, workflow or lab system · risk-based evaluation and validation · decision checklists and RFP questions · scored evaluation · where V5 fits and sources.

Get the quality management guide

We ask for your name and email so we can handle this request. The PDF downloads in your browser. Privacy policy

Guide page 6: out-of-spec result to investigation to CAPA, with effectiveness criteria examplesGuide page 7: audits, complaints, supplier quality and traceability, with what each workflow should recordCover of the Quality Management Buyer Guide

Audits connected to the rest of quality

Findings link to deviations, CAPA, holds, documents and training in the same system, so follow-up is visible and nothing is re-keyed.

Quality managementDeviationsMobile audits

What's included

What audits and CAPA include, and which plan each item needs. Compare plans

Audits

Plan, record and grade findings against your own checklists.

Internal and supplier audits · Document control for checklists · Supplier portal

Explore audits
  • Internal and supplier auditsProfessional and Enterprise
    Findings against checklist lines, graded under your rules.
  • Document control for checklistsProfessional and Enterprise
    Checklists under revision with review and approval.
  • Supplier portalProfessional and Enterprise
    Suppliers share documents and respond to corrective action requests.
  • Audit log (view)
    Who changed what and when, on every record.
  • Audit-readiness scoringEnterprise
    A live readiness index across Part 11, GxP and ISO areas.

CAPA and follow-up

Owners, due dates and a check that the fix worked.

CAPA · Deviation management · Training and competence

Explore CAPA
  • CAPAProfessional and Enterprise
    Root-cause workflow, actions with owners and due dates, effectiveness checks.
  • Deviation managementProfessional and Enterprise
    Findings and events linked to deviations and holds.
  • Training and competenceProfessional and Enterprise
    Training per document revision.
  • Supplier scorecardsProfessional and Enterprise
    Supplier performance, recalculated nightly.
  • Electronic signaturesProfessional and Enterprise
    Signatures with meaning, designed for 21 CFR Part 11.
  • Risk managementEnterprise
    FMEA and ICH Q9-aligned assessments.

Grades and follow-ups are confirmed by people under your procedures. V5 keeps the evidence; it does not by itself establish certification.

Try it with your next internal audit.

Start your free trial

Or (you can edit the question before sending) or .