Agentic QMS

Document control

Create a controlled document, let the AI review each draft version, disposition findings, approve the version and make it effective on a date, collect read-and-understood training signatures, and manage periodic review and obsolescence.

In the portal: /app/qms/documents

The document procedure

Document control
  1. Person

    1. Create the record

    Type, number, owner, review period, draft file

  2. AI drafts

    2. Review the draft

    Structure, findings, training impact

  3. Person

    3. Disposition findings

    Resolved, not applicable or open

  4. Person

    4. Set outcome and effective date

  5. E-signature

    5. Approval

    Makes the version effective (or obsolete)

  6. E-signature

    6. Read and understood

    Training signatures on the effective version

  7. System

    7. Periodic review

    Due after 12, 24 or 36 months

  • A revision: add a new version (2.0) with its file; it starts as a draft and goes through review and approval again. The previous effective version becomes superseded.

Create a controlled document

  1. Step 1: Open Documents and choose New controlled document.
  2. Step 2: Leave Document number empty to get the next number for the type (SOP, WI, POL, FRM, SPEC, PRT, RPT, MBR or DOC series), or type an unused number.
  3. Step 3: Choose the Document type, title, department, document owner and Periodic review every 12, 24 or 36 months; add what it supersedes, the purpose and keywords.
  4. Step 4: Give the Version number (e.g. 1.0) and a summary of changes, and attach the draft as Document under review, with references (current version, referenced procedures, regulatory text, redline).
  5. Step 5: Keep Review the draft now (AI) ticked and choose Create and review.

Review, approval and training

  • The AI checks the structure (purpose, scope, responsibilities, definitions, procedure, records and forms, references, revision history) and lists findings by severity (Major, Minor, Observation) and category (clarity, completeness, consistency, compliance, data integrity, safety, formatting), with location and suggestion.
  • Disposition every finding: Resolved in the draft, Not applicable or Open, with a reason.
  • Set the outcome: Approve and make effective (needs the effective date, every Major finding dispositioned, and the training roles if training is required) or Obsolete.
  • After approval, each trained person signs I have read and understood version X with email and password, once per person and version.
  • Stamped copies of the document download the file stamped CONTROLLED COPY - APPROVED, IN REVIEW - NOT FOR USE, DRAFT - NOT FOR USE or SUPERSEDED - FOR REFERENCE ONLY.