Document control software for GMP: SOPs, controlled documents and training

What the module does

• Controlled documents numbered from the series of their type (SOP, WI, POL, FRM, SPEC, PRT, RPT, MBR or DOC), with the title, department, document owner, what it supersedes, purpose, keywords and a periodic review every 12, 24 or 36 months.
• Versions, each a fingerprinted file: a revision is added as the next version, starts as a draft and goes through review and approval again, and the previous effective version becomes superseded.
• An AI review of each draft: the standard structure (purpose, scope, responsibilities, definitions, procedure, records and forms, references, revision history) and findings by severity (Major, Minor, Observation) and category, each with its location and a suggested fix.
• The training impact from the same review: whether people must be trained before the version becomes effective and the roles to train, with the regulations the document implements and questions for the approvers.
• Findings dispositioned with a reason as resolved in the draft, not applicable or open; every Major finding must be dispositioned before approval.
• Approval in review and approval with electronic signatures, set to make the version effective on its effective date or to make the document obsolete.
• Read-and-understood training: each trained person signs "I have read and understood version X" with email and password, once per person and version.
• Periodic review due from the effective date, shown in the work queue and the Agentic QMS overview; an obsoleted document is withdrawn from use and no review falls due.
• Stamped copies: CONTROLLED COPY - APPROVED, IN REVIEW - NOT FOR USE, DRAFT - NOT FOR USE or SUPERSEDED - FOR REFERENCE ONLY, exported as locked PDFs that cannot be edited.

How it fits the platform

Document management puts every document the quality system produces in one searchable index: controlled documents and their versions, validation protocols and reports, risk assessments, change controls, CAPAs, investigations, QC specifications and certificates of analysis, with every attached file and its fingerprint. The hub stores nothing of its own, so what it finds is the record itself, with its signatures and audit trail. Existing approved documents come in through the legacy import as their final approved PDFs, keeping their document numbers.

A change control names the documents and training it affects, and the revision is made here. The electronic lab notebook lets an analyst follow only the effective version of a method, and the controlled document lists the runs that followed it. When an asset is decommissioned in the CMMS, the close-out lists the controlled documents to obsolete.

Where people decide

The AI reviews the draft and suggests wording; it never states that a document is approved or compliant. The author decides what to change and dispositions each finding with a reason, the approvers sign the version effective or obsolete, and each trained person signs their own read-and-understood attestation.