Quality events

Complaint handling

Log a complaint as received, let the AI draft the complaint record with quoted evidence, decide the route (pharmacovigilance, investigation, trend only or close), confirm receipt to the reporter, and draft the preliminary evaluation that starts the investigation.

In the portal: /app/complaints

The complaint procedure

From complaint received to investigation
  1. Person

    1. Paste the complaint

    Intake channel and text, identifiers removed

  2. AI drafts

    2. Run triage

    Record fields with quotes, flags, adverse event check

  3. Person

    3. Check and edit fields

    Each edit needs a reason

  4. Person

    4. Decide the route

    PV, investigation, trend only or close

  5. Person

    5. Confirm receipt

    Email to the reporter, logged

  6. AI drafts

    6. Preliminary evaluation

    IS / IS NOT, priority, hypotheses, next steps

  7. Person

    7. Accept next steps

  8. E-signature

    8. Review and sign

  • Possible adverse event flagged → route to pharmacovigilance for assessment.
  • Decision "Open an investigation" → Start the root cause investigation (a linked investigation record).

Log a complaint

  1. Step 1: Open Complaint handling and choose New complaint.
  2. Step 2: Remove patient names, contact details and other personal identifiers from the text before you paste it.
  3. Step 3: Choose the Intake channel: Email, Call center, Web form, Distributor, Sales representative or Other.
  4. Step 4: Paste the Complaint text as received (20 to 8,000 characters). Load an example fills in a sample.
  5. Step 5: Choose Run triage. The record is created (CMP number) and the AI draft appears.

What the AI drafts

  • A summary, and the record fields (product, lot or batch, event date, reporter, category, patient involved, harm reported, sample available), each with the exact quote it rests on, highlighted in the complaint text.
  • Category: Product quality, Container closure or packaging, Labeling, Lack of effect, Patient reaction, Device or delivery system, Suspected counterfeit or tampering, or Other.
  • Possible adverse event, with its rationale. When it is flagged a banner says: route to pharmacovigilance for assessment.
  • Flags, missing information, suggested next steps and a draft acknowledgement to the reporter.

Every field can be edited; each change needs a reason and is kept in the audit trail. The complaint text itself can be corrected, and the original stays in the audit trail.

Decide and confirm receipt

Reviewer decisionWhen
Route to pharmacovigilanceA possible adverse event or patient reaction
Open an investigationA quality defect that needs root cause analysis
Trend onlyKnown, low-risk issue recorded for trending
Not a complaint: closeNot a product complaint

The first decision needs no reason; changing it does. Add a Note for context.

  1. Step 1: Under Confirm receipt to the reporter, enter the reporter's email, an optional reference, the subject and the message (prefilled with the AI acknowledgement).
  2. Step 2: Tick Send me a copy if you want one, and choose Send confirmation. Replies go to you, and the email is logged on the record.

Preliminary investigation evaluation

  • Choose Draft preliminary evaluation: a problem statement with IS / IS NOT (what, where, when, extent; unknowns written "To confirm"), the patient safety and product quality impact, other lots that could be affected, and whether regulatory or pharmacovigilance reporting assessment is needed.
  • Suggested priority (Critical, Major or Minor) is a suggestion; classification is your decision under your SOP.
  • Preliminary hypotheses to test across the 6M categories, each with how to test it.
  • Next steps to start the investigation, each with an owner role and timing; mark each Accept or Reject.
  • Initiate the investigation in your QMS: copy the draft entry, then record the QMS number with Link QMS record.

When the decision is Open an investigation, choose Start the root cause investigation. A new investigation opens with the complaint text, summary, problem statement and your note as its write-up, linked back to the complaint ("Originates from").

Complaints have no sign blockers: route them for review and approval when the record is complete (see Records, review and signatures).