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No investigation starts from scratch.

Devia takes each deviation from the first report to closure. It asks for what your procedures require, drafts the root cause from the cases that came before, checks whether the cause has come back, and leaves every decision to your team.

How Devia takes a deviation from report to closure

  1. 01

    Report

    Whoever found it describes it in plain words and adds photos or PDFs. Devia asks, one question at a time, for whatever your procedure requires.

  2. 02

    Classify

    Severity, risk rating, quality impact and due date, proposed from your own rules and from similar past events. Devia also says when an event is not a deviation at all.

  3. 03

    Investigate

    Ishikawa and 5-Why drafts, built from the report, your SOPs and the past deviations most like it. Your team confirms the root cause.

  4. 04

    Check recurrence

    Devia searches every closed record for the same cause, and checks whether a CAPA was meant to stop it. A reviewer accepts or rejects each match.

  5. 05

    Act

    Corrective and preventive actions, recommended for the confirmed cause, then assigned to an owner with a due date.

  6. 06

    Close

    The owner resolves the deviation and QA closes it. The closure report is ready in the format your QMS expects.

Recurrence check

Recurring means the fix didn’t hold.

DEV-2036 shares its cause with a record that never had a CAPA, so it is flagged as a repeating cause that needs a systemic action. Devia counts a deviation as recurring only when two tests pass: an earlier record shares its root cause, and a CAPA for that cause was verified effective, yet the cause came back. DEV-2041 is such a case.

Devia never decides recurrence. It finds the candidates and compares their causes; a reviewer accepts or rejects each one, and the verdict follows from those decisions.

DEV-2041CR-04 excursion: the alarm did not sound

Root cause: change control missed the alarm requalification.

Panel changed without alarm requalification

  • Same root cause
  • A verified CAPA failedCAPA-1797-01 · weekly alarm test, verified effective in January

Recurring

VerdictWaiting for a reviewer

Capabilities

Capabilities

Intake that follows your SOPs

Devia turns your procedures into the questions a report has to answer, so nothing is missing when the investigation starts.
  • Questions drawn from your SOPs
  • Photos and PDFs read with the report
  • Events that are not deviations, flagged

Your rules, built in

Severity, risk rating, quality impact and due dates follow the categories and the risk model in your own procedures.
  • Risk rating scored from your risk model
  • Due dates from your deadline rules
  • Categories and sites set for your company

Records in your QMS format

Each closed deviation produces a closure report with the sections and fields your QMS record expects.
  • On screen and as a PDF
  • Sections set to match your QMS record
  • Every change in the audit trail

Ask Devia

Ask about all your deviations in plain words: what happened this week, what is similar, what is stuck.
  • Summaries of any period
  • Similar cases on request
  • Open items with no recent activity

Roadmap

Deviation management is live. The rest of the quality system is next.

Devia is built in four layers, from the shop floor to the inspector. Deviation management runs today, with a dashboard of deviation metrics from the operations layer. The rest is what we are building next.

  1. 01Robust operationsPrevent unplanned events and control process variability.Deviation metrics dashboard (Live)Out-of-trend and OOS detection (Next)Predictive process control (Next)Computer vision for process QC (Next)
  2. 02Deviation managementWhen issues occur, remediate them and prevent recurrence.SOP retrieval and configuration (Live)Triage and classification (Live)Quality investigation (Live)Remediation and CAPA recommendation (Live)Recurrent deviation detection (Live)
  3. 03Trends and oversightFind the recurring issues that remain, diagnose them and act.Trend monitoring (Next)CAPA effectiveness (Next)Risk scoring (Next)Quality dashboard (Next)
  4. 04Governance and regulationIndependent checks on compliance and process adherence across the other three.Inspection readiness (Next)Inspection-day support (Next)Observation response (Next)Regulatory intelligence (Next)

See Devia investigate a deviation from your own records.