Agentic QMS

Change control

Propose a change, let the AI assess impact across nine areas and the ICH Q9 risk with quoted evidence, plan the tasks, get approval to implement, complete the tasks with evidence, verify effectiveness and close.

In the portal: /app/qms/changes

The change control procedure

Change control
  1. Person

    1. Propose the change

    Type, urgency, description, reason, documents

  2. AI drafts

    2. Assess the change

    Impact, risk, tasks, approvers, effectiveness

  3. Person

    3. Plan tasks and approvers

  4. E-signature

    4. Approval to implement

    Milestone; records Approved

  5. Person

    5. Do the tasks

    Evidence of completion for each

  6. Person

    6. Record effectiveness

    Criterion met, not met or not required

  7. E-signature

    7. Closure

    Final; signs and locks

  • Regulatory filing may be needed → open a regulatory impact screening (Regulatory submissions).
  • Effectiveness not met → raise a CAPA and link it before closing.
  • The author can record Rejected or Withdrawn (with a reason) instead.

Propose a change

  1. Step 1: Open Change controls and choose New change control (or Raise a change control from an investigation or CAPA).
  2. Step 2: Give a title, the Type of change (manufacturing process, equipment or facility, computerized system, component or supplier, specification or method, document or procedure, packaging or labelling, organization or outsourcing, other) and the Urgency: Routine, Expedited or Emergency (implemented before approval).
  3. Step 3: Add the products, sites or lines affected, who requested it, the proposed date, the Description of the change (at least 20 characters) and the reason.
  4. Step 4: Attach the change request, impact or risk assessment, current procedure, drawings or URS, validation documents or supplier documentation.
  5. Step 5: Keep Assess the change now (AI) ticked and choose Create and assess.

Impact and risk assessment

  • Classification: Major, Minor or Like-for-like, with the rationale and quoted source.
  • Impact in nine areas (product quality, patient safety, validation and qualification, regulatory filings, documents and procedures, training, supplier and materials, data integrity and computerized systems, environment, health and safety), each None identified, Possible or Likely.
  • ICH Q9 risk: severity, probability, detectability and overall level (High, Medium, Low); whether regulatory screening and validation are needed.
  • Documents and training affected, suggested tasks with timing, suggested approver roles, an effectiveness check, and questions for the requester.

Assess again needs a reason; it replaces the assessment and open suggestions but keeps your edits, decisions and completed items.

Tasks, approval and closure

  • Tasks have a type (assessment, documentation, validation or qualification, training, regulatory, implementation, verification, other) and timing (before approval, before implementation, at implementation, within 30 or 90 days after). Mark each Done with evidence of completion, or Not required with a reason. Up to 40 tasks.
  • Before Approval to implement: an assessment and at least one task, and the change not rejected or withdrawn. The final approver's signature records the decision Approved.
  • Before Closure: a decision; if approved, no open tasks; the effectiveness result recorded. "Not met" blocks closure until a CAPA is raised and linked.