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QMS tour4 steps · about 2 minutes

From deviation to CAPA — on one audit trail

Follow a real deviation from the shop floor through its decision, closure and CAPA — with every signature and change on the record.

Start the tour Pharma QMS software
  1. Deviation record DEV/2026/0017 showing title, Major classification, reason for change, department and initiator

    Step 1 of 4Major · Closed

    A deviation, recorded where it happened

    DEV/2026/0017 records a drying time that ran past its validated limit. It is classified Major, linked to its department and raised by a named person.

    1. Classification & status
    2. Raised by a named person
    3. Locked once closed
  2. Deviation decision by the plant head and closure by Head QA, each with name and time-stamp

    Step 2 of 4Decision e-signed

    Decision and closure, each by a different person

    The plant head decides to proceed; Head QA closes the deviation once its actions are complete. Each step shows who acted and when, in the site’s local time.

    1. Decision by the plant head
    2. Closed by Head QA
    3. The rationale, on record
  3. CAPA record raised from an internal audit, with the action, owner, target date, reviewer and approver

    Step 3 of 4CAPA closed

    The CAPA, tracked to closure

    An internal audit finding raised this CAPA. The action has an owner and a target date; a QA officer reviews it and Head QA approves it — two different people.

    1. Source: internal audit
    2. Owner & target date
    3. Reviewed and approved separately
  4. Activity timeline of the deviation listing each event with user, time and old and new values

    Step 4 of 4Audit trail

    Every change on the audit trail

    The activity timeline shows who changed what, when and why — the old and new value of every field, readable by an inspector without a database query.

    1. Each event, user and time
    2. Old value → new value
    3. The decision and its reason

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