Agentic QMS

CAPA

Open a corrective or preventive action from an investigation, finding or trend; let the AI review the plan for adequacy; approve the plan; complete the actions with evidence; check effectiveness and close.

In the portal: /app/qms/capas

The CAPA procedure

CAPA
  1. Person

    1. Open the CAPA

    Often from an investigation, prefilled

  2. AI drafts

    2. Review the plan

    Adequacy, gaps, extent of condition

  3. E-signature

    3. Plan approval

    Milestone

  4. Person

    4. Do the actions

    Evidence for each

  5. Person

    5. Effectiveness check

    Result against the criterion

  6. E-signature

    6. Closure

    Effective: close, or Not effective: escalate

  • Not effective → record "Not effective: escalate" and open the follow-up CAPA or investigation.

Open a CAPA

  1. Step 1: From an approved investigation choose Open a CAPA record from this investigation: the title, type, origin, problem statement, root cause, classification and accepted actions are carried in. Or open CAPAs and choose New CAPA.
  2. Step 2: Set the Type (Corrective, Preventive, Corrective and preventive), Classification (Critical, Major, Minor), Originates from and the originating reference, owner role and target closure date.
  3. Step 3: Write the Problem statement (at least 20 characters) and the Root cause.
  4. Step 4: Keep Review the plan now (AI) ticked and choose Create and review.

The plan, actions and effectiveness

The AI review gives an adequacy verdict (Adequate, Gaps found, Cannot judge from the record), findings, suggested actions, the extent of condition, an effectiveness method, criterion and timeframe, risks and regulatory notes.

  • Actions are corrections, corrective actions or preventive actions, each Planned, In progress, Done (with evidence) or Cancelled (with a reason). Up to 30 actions.
  • Before Plan approval: at least one action and a defined effectiveness method and criterion. Retraining cannot be the only corrective or preventive action.
  • Before Closure: "Effective: close" needs every action done and effectiveness met (or not required); "Not effective: escalate" needs effectiveness recorded as not met.

Rule: Inspectors expect actions that remove the conditions that made an error possible. Retraining alone is flagged and blocks plan approval.