V5 Ultimate
Deviation management

Record what went wrong while the facts are fresh.

Capture the problem at the step, against the work order and lot, with evidence attached. A person records cause and impact.

Start your free trial Follow one deviation

7-day free trial, no card required. Deviation records are in Professional and Enterprise. Every plan records checks at the step and has a QA review queue.

Operator in hood, mask, safety glasses and blue gloves tapping a mounted touchscreen beside an enclosed production machine, with a colleague in the same protective clothing behind

  • Facts captured on the spot.

    The operator records what happened at the step, linked to the work order, lot and photos.

  • Product protected while you look.

    The affected lot can be put on hold, so it waits for a person's decision.

  • From cause to corrective action.

    The responsible person records cause and impact and can raise a CAPA that keeps the link.

Follow one deviation

Line 3 · start-up · WO-5120

Raise it where it happened

Try it: the operator scans an older label roll. Raise the deviation, then record containment.

New deviation
Not yet raised
  • Work order—
  • Step—
  • Lot—
  • Raised by—
  • What happened—
Containment
Lot L-5120
Labelled so far
Rev B rolls
Quality notified

Nothing is held until someone records it.

Worked example. The AI class suggestion (Professional and Enterprise) is a draft a person confirms.

How deviations work: capture, hold, investigation and CAPA

Tap a step below to see what happens.

Step 1 of 4

New deviation · WO-5120
Line 3 · Step 2 Label set-up
  • What happenedLabel rev B loaded; rev C required
  • Recorded byOperator J. Okafor · 06:42
  • LinkedWO-5120 · Step 2 · lot L-5120
  • ReferenceDEV-1104

Work order, step, lot, person and time are filled in from where it was raised.

Recorded at the step, by who saw it

  • Raise it from the step on the shop-floor screen. The work order, step, lot, person and time are filled in for you.
  • Write what happened in plain words and attach a photo or note while you are still at the line.

Checks at the step are in every plan. Linked deviation records need Professional or Enterprise.

More on record: full record and set-up

Also on this record

Photo
Label roll attached

Deviations can also start from receiving, a complaint or an audit finding, not only from the line.

Fields
Which fields a deviation has follows your procedures and workspace set-up. This example is fictional.
Opened automatically?
Not claimed here. Whether an event prompts a deviation depends on your configuration; confirm it with us.
AI first draft
Where enabled, AI can suggest a description from the recorded step data for the operator to edit. Professional and 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.

  • 1Know what a usable deviation record holds.
  • 2Follow an issue to a person's closure.
  • 3Test deviation handling with one of your events.
See what's inside
  • What a usable deviation record holds, and how out-of-spec results and CAPA effectiveness checks connect to it.
  • An eight-stage map from issue raised to human closure, with the evidence and owner at each stage.
  • Decision checklists, RFP questions and a scored sheet to test deviation handling with one of your own events.

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 4: eight-stage map from issue raised to human closure, with evidence and owner at each stageGuide page 6: deviations, out-of-spec results and CAPA effectiveness, with what to check at each stageCover of the Quality Management Buyer Guide

One record from the line to the fix

Deviations link to the work order, lot, CAPA and release review, so nobody re-keys the facts and the reviewer sees the whole story.

Quality managementAudits & CAPAQC release

What's included

Everything below is about deviations and what connects to them. Each item says which plan it needs. Compare plans

Recording and containing

Capture the facts at the source and stop the problem spreading.

Checks at the step · QA review queue · Deviation management

Explore recording
  • Checks at the step
    Results recorded against limits and flagged when outside.
  • QA review queue
    Completed work waits for a person to review it.
  • Deviation managementProfessional and Enterprise
    Linked to work order, step and lot, with holds and approvals.
  • SMS notifications
    Text alerts for deviations and releases.
  • Routed notificationsProfessional and Enterprise
    Email and SMS triggers with escalation and a delivery record.

Investigating and closing

People decide the cause; V5 keeps the evidence and the history.

AI deviation triage · Audit-trail explainer · CAPA

Explore investigation
  • AI deviation triageProfessional and Enterprise
    Suggests a classification, a CAPA and a draft investigation for a person to confirm.
  • Audit-trail explainerProfessional and Enterprise
    Ask why something happened; answered from recorded history.
  • CAPAProfessional and Enterprise
    Root cause, actions with owners and due dates, effectiveness checks.
  • Electronic signaturesProfessional and Enterprise
    Signatures with meaning, designed for 21 CFR Part 11.
  • Tamper-evident audit trailProfessional and Enterprise
    Designed for ALCOA+ data integrity.
  • Risk managementEnterprise
    FMEA and ICH Q9-aligned assessments.

Causes, classifications and closure are recorded by people under your procedures. V5 supports your quality system; it does not by itself make you compliant or validated.

Try it with one of your own deviations.

Start your free trial

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