V5 Ultimate
Quality management

Turn quality issues into clear, owned action.

When something goes wrong, V5 keeps the issue, its evidence, the people responsible and the corrective and preventive actions (CAPA) together, linked to the work it affected. A person decides when it is closed.

Start your free trial See how an issue becomes action

7-day free trial, no card required. Every plan has a QA review queue. Deviations, CAPA, documents, training and audits are in Professional and Enterprise.

Quality technician in cleanroom suit, mask and glasses holding up a sample jar while working on a tablet

  • Evidence attached, not chased

    The issue links to the batch, step, lot or document it concerns, so investigators start from the facts.

  • Every action has an owner

    Corrective and preventive actions get a named owner and a due date, and overdue work is easy to see.

  • Closed when it worked

    An effectiveness check comes before closure, and a person signs the decision. Approval routes follow your procedures.

From a problem on the line to a fix that holds

A seal check on a packing line falls outside its limit. Here is everything V5 keeps together until a person closes it.

One quality issue, start to finish

Everything needed to close it properly, in one place.

Try it: choose any part of the journey to see what V5 keeps there.

Decision

The quality manager reviews the evidence and signs the closure. V5 records who decided and when; it does not make the decision. Approval routes follow your procedures.

Example issue. Fields, routes and who can approve follow your procedures and role permissions.

Follow the linked quality records
One quality event · WO-2207

Follow the thread from check to decision

Try it: select any record, or press Next link, to see what it holds and where it leads.

Seal check · WO-2207 step 5
Result
Outside limit
Recorded by
A. Patel · 09:02
Lot
FG-310-0930

Opens DEV-0391 with work order, step and lot already filled in.

Checks are recorded in every plan.

Why it matters

Each record carries the links to the others, so the reviewer at the end sees the check, the cause, the fix and who was trained without rebuilding the story.

Record 1 of 6

Worked example.

The full journey in detail: deviation, investigation, CAPA, document change, training and audit

Tap a step below to see what happens.

Step 1 of 6

Seal check · WO-2207
Line 2 · Step 5
  • ResultOutside limit
  • Recorded byA. Patel · 09:02
  • StepPaused
  • DeviationDEV-0391 opened

The deviation already knows the work order, step and lot.

Caught at the step, not at review

  • Checks sit inside production steps, so a result outside its limit is flagged the moment it is entered.
  • The deviation opens with the work order, step, lot and person already linked. Nobody retypes them.

Checks are recorded in every plan. Linked deviation records are Professional and Enterprise.

More on detect: full record and set-up

Also on this record

Lot affected
FG-310-0930

Complaints and audit findings can start quality records too, not only line checks.

Where events come from
Line checks, lab results, receiving, customer complaints and internal or supplier audits.
What needs attention
The assistant can list open deviations, overdue maintenance and expiring lots, each with a link to the record.
Lab results
Out-of-specification lab results, sampling and methods are in Lab & QC (Enterprise).
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.

  • 1Map every issue from raised to human closure.
  • 2Set CAPA effectiveness criteria before you act.
  • 3Separate regulation, configured workflow and lab features.
See what's inside
  • An eight-stage map from issue to human closure, showing the evidence, owner and decision at each stage.
  • How to define CAPA effectiveness criteria up front, and how out-of-spec results, deviations and CAPA link together.
  • A table separating what regulations ask, what your procedure configures and what needs laboratory features, plus RFP questions and scoring.

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

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Guide page 6: out-of-spec result to investigation to CAPA, with effectiveness criteria examplesGuide page 4: eight-stage map from issue raised to human closure, with evidence and owner at each stageCover of the Quality Management Buyer Guide

Quality that knows what happened on the floor.

Because quality records live with production, stock and documents, a deviation already knows its work order and lot, a CAPA can point at the SOP to revise, and training follows the new revision. People stay responsible for every decision.

See shop-floor executionSee document controlSee the whole product

What's included

Every plan has checks at the step, a QA review queue and a view of the audit log. The quality system itself is in Professional and Enterprise; each item says which plan it needs. Compare plans

Deviations, complaints and CAPA

Record what went wrong, fix the cause, and prove it worked.

Checks at the step · QA review queue · Customer specifications

Explore quality events
  • Checks at the step
    Recorded results against limits, flagged when outside.
  • QA review queue
    Completed work waits for a person to review it.
  • Customer specificationsAvailability to confirm
    Per-customer limits, product naming and CoA layout; approved versions are e-signed and frozen.
  • Deviation managementProfessional and Enterprise
    Linked to work order, step and lot, with holds and approvals.
  • AI deviation triageProfessional and Enterprise
    Suggests classification, CAPA and a draft investigation for a person to confirm.
  • CAPAProfessional and Enterprise
    Root cause, actions with owners and due dates, and effectiveness checks.
  • Customer complaintsProfessional and Enterprise
    Intake and investigation, linked to lots and orders.
  • Risk managementEnterprise
    FMEA and ICH Q9-aligned risk assessments.

Documents and change

One approved version in force, every change explained.

Document control · Change control · Electronic signatures

Explore documents
  • Document controlProfessional and Enterprise
    SOPs and work instructions under revision, with review and approval.
  • Change controlProfessional and Enterprise
    Impact assessment and approvals for proposed changes.
  • Electronic signaturesProfessional and Enterprise
    Signatures with meaning, designed for 21 CFR Part 11.
  • Two-signature approvalsProfessional and Enterprise
    Two approvers before a formula revision takes effect.
  • IQ/OQ and validation supportEnterprise
    Offered with Enterprise.
  • Draft from existing documents
    Upload an SOP and V5 drafts its structure for your review.

People and suppliers

Only trained people and approved suppliers touch the work.

Training and competence · Supplier qualification · Certificate intake (AI)

Explore people and suppliers
  • Training and competenceProfessional and Enterprise
    Training per revision, with kiosk blocking where configured.
  • Supplier qualificationProfessional and Enterprise
    Approve suppliers and monitor them over time.
  • Certificate intake (AI)Professional and Enterprise
    Reads supplier certificates and CoAs into the right record for review.
  • Supplier portalProfessional and Enterprise
    Suppliers share documents and responses through a portal.
  • Calibration
    Instrument schedules, tolerance checks and certificates.
  • Skills matrixEnterprise
    Operator-by-competency matrix, printable for review.

Audits, review and evidence

Find gaps early and show the evidence when asked.

Audit log (view) · Tamper-evident audit trail · Internal and supplier audits

Explore audits and evidence
  • Audit log (view)
    Who changed what and when, on every record.
  • Tamper-evident audit trailProfessional and Enterprise
    Designed for ALCOA+ data integrity.
  • Internal and supplier auditsProfessional and Enterprise
    Findings route to deviations, CAPA, holds or training.
  • Audit-trail explainer (AI)Professional and Enterprise
    Ask why something happened, answered from the recorded history.
  • Supplier scorecardsProfessional and Enterprise
    Supplier performance, recalculated nightly.
  • Regulated reportsProfessional and Enterprise
    Batch record, device history record and certificate of analysis.
  • Audit-readiness scoringEnterprise
    A live readiness index across Part 11, GxP and ISO areas.
  • Lab & QC, SPC and stabilityEnterprise
    Samples, results, trends and stability programmes.

Availability to confirm: the capability exists in V5, but which plans include it, and whether it is enabled for you, is not yet confirmed — ask us. V5 supports your quality system; it does not by itself make you certified, compliant or validated. Approval routes follow your procedures and role permissions.

Try it with one of your own quality events.

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