Deviation management

Deviation management software that helps do the investigation work

Ovada gathers evidence for planned and unplanned events, reconstructs what happened, flags missing or conflicting information, drafts the deviation record, and recommends whether CAPA should be considered.

See Ovada work a deviation Explore CAPA management
  • Planned and unplanned
  • Timeline rebuilt
  • Every statement cited
  • Owner signs
Deviation · unplannedDEV-2291
Temperature excursion, chamber 418 Sep · warehouse · limit 25 °C
Excursion · 31 min3 lots in scopeSOP-WH-011 v5 applied
Record drafted · 4 sources cited · CAPA recommendedQA decides

01 / Deviation Management

The form is not the hard part

A deviation starts with a report. The real work is understanding what happened and documenting it well enough for a defensible conclusion.

What the investigation takes

6 items
  1. 01Reconstructing the sequence of events
  2. 02Locating procedures, records, and communications
  3. 03Determining which requirements applied
  4. 04Following up for missing information
  5. 05Finding conflicts with the approved procedure
  6. 06Assembling the record for review

Your QMS stores and routes the deviation. Ovada does more of the work required to complete it.

02 / Deviation Management

From reported event to signed deviation record

  1. 01
    Receive the event.

    A report, assignment, request, or system event starts the workflow.

  2. 02
    Apply the approved procedure.

    Ovada uses your deviation procedure, evidence requirements, roles, and decision paths.

  3. 03
    Gather and reconstruct.

    It pulls related records and communications, then rebuilds the sequence of events.

  4. 04
    Support the investigation.

    It documents known facts and flags missing or conflicting information for follow-up.

  5. 05
    Draft the record.

    It prepares the deviation record, cites the evidence, and recommends whether CAPA should be considered.

  6. 06
    Route for review and sign-off.

    The owner decides the conclusion, assesses risk, decides on CAPA, and signs.

  7. 07
    Preserve the approved record.

    The signed deviation, evidence, and review history are kept together.

03 / Deviation Management

Planned and unplanned deviations

Planned deviations

Ovada gathers the proposed change, affected procedures, rationale, controls, time period, and approvals needed before the work runs.

Unplanned deviations

Ovada assembles the event record, applicable requirements, available evidence, and open questions the investigation must answer.

Your procedures define the workflow, terminology, and approval path. A deviation can touch procedures, materials, suppliers, equipment, and CAPAs, and Ovada gathers that context across your connected systems.

04 / Deviation Management

What qualified people continue to own

Reserved for qualified people

6 items
  1. 01Investigation conclusions
  2. 02Impact and risk assessment
  3. 03Root-cause determination
  4. 04Disposition of affected work or material
  5. 05The decision to open a CAPA
  6. 06Final review and sign-off

These are five of Ovada’s 62 skills. The ones that matter most depend on your operation. See all 62 skills.

Frequently asked questions about deviation management software

What is deviation management software?

Deviation management software helps teams document, investigate, route, approve, and preserve records for planned and unplanned deviations. Ovada adds an AI quality agent that gathers the evidence and prepares the record across your connected systems.

Can Ovada investigate a deviation?

Ovada gathers and organizes evidence, reconstructs the sequence of events, flags missing or conflicting information, and prepares material for the investigation. People own the conclusion and sign-off.

Does Ovada decide whether a CAPA is required?

No. Ovada prepares a recommendation from the evidence and your procedure. The authorized quality person decides whether a CAPA is warranted.

Does Ovada replace our deviation system?

No. Your QMS remains the system of record. Ovada does the permitted work across your connected systems and prepares the deviation record for review.

How does Ovada support traceability?

Every finding links to its supporting records, and the review history is preserved with the approved deviation record.

See Ovada at work

Complete more deviation work before it reaches the reviewer

Bring one planned or unplanned event and watch Ovada prepare the work leading up to sign-off.

See Ovada work a deviation Explore CAPA management