# Document control software for GMP: SOPs, controlled documents and training
QLogix document control is GMP document management software for controlled documents: SOPs, work instructions, policies, forms, specifications, protocols, reports and master batch records, each with its versions, owner and review period. The AI reviews each draft version for structure, clarity, completeness, consistency, compliance and data integrity, and says whether training is required and for which roles. The author dispositions every finding, approvers sign, the version becomes effective on its date, and each trained person signs that they have read and understood it. Periodic review falls due from the effective date, and every exported copy is stamped with its state.
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## 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next version, starts as a draft and goes through review and approval again, and the previous effective version becomes superseded.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review due from the effective date, shown in the work queue and the Agentic QMS overview; an obsoleted document is withdrawn from use and no review falls due.
- Stamped copies: CONTROLLED COPY - APPROVED, IN REVIEW - NOT FOR USE, DRAFT - NOT FOR USE or SUPERSEDED - FOR REFERENCE ONLY, exported as locked PDFs that cannot be edited.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.

## Where people decide
- A version becomes effective only through approval in review and approval, on the effective date set before approval.
- Every Major finding from the AI review is dispositioned with a reason before the version can be approved, and the roles to train are named when training is required.
- Read and understood is an electronic signature, with email and password, once per person and version.

## Built to
- 21 CFR 211.100 written procedures
- 21 CFR Part 820 (QMSR) and ISO 13485 clause 4.2.4
- EU GMP Chapter 4 Documentation
- 21 CFR 211.25 and EU GMP Chapter 2 training
- 21 CFR Part 11 and EU GMP Annex 11
- MHRA GxP data integrity guidance

## White paper
One quality system, one AI layer
The case for an Agentic QMS
[Download the white paper](https://qlogix.ai/whitepapers#agentic-qms)

## Licensing
Per user per month, on its own or with other modules, ordered by purchase order from the client portal. Every module writes to the same audited records.
[Ask for a quote](https://qlogix.ai/contact)

## Questions about Document control

### What is document control software?

Document control software manages controlled documents such as SOPs, work instructions and specifications through drafting, review, approval, distribution, training, periodic review and obsolescence, with an audit trail and electronic signatures. QLogix document control does this on the same audited records as change control, CAPA and the other QLogix modules, with an AI review of each draft.

### How does the AI review an SOP?

It checks the draft against the standard structure, reads the procedure as the person who must follow it, and compares it with the referenced or linked documents provided. Findings are listed by severity and category with their location and a suggested fix, together with the training impact. The author dispositions each finding with a reason; the AI does not approve anything.

### How is read-and-understood training recorded?

After the version is approved, each trained person signs "I have read and understood version X" with their sign-in email and password. It is an electronic signature recorded once per person and version, with the time, in the audit trail.

### How does periodic review work?

Each document has a review period of 12, 24 or 36 months, and the next review falls due that long after the effective date. Documents due for periodic review appear in the work queue and on the Agentic QMS overview; an obsoleted document has no review due.

### Can we import our existing SOPs?

Yes. An administrator imports existing approved documents as their final approved PDFs, giving for each the legacy document number, title, type, version, effective date and who approved it and when, and signs the batch. A file that is not a PDF, or a document number already in use, is refused, and every import is audited with the legacy approval details.

### How is it licensed?

Controlled documents are part of the Agentic QMS, with change control and CAPA; Document management, the index of every QMS document, is licensed as its own module. Both are per user per month, on their own or with other modules, ordered by purchase order from the client portal. There is no card payment or self-serve plan.

## Reading
- [AI in document management and validation workflows for life sciencesDocument control under EU GMP Chapter 4, 21 CFR Part 11 and Annex 11 is about controlled versions, approvals, effective dates, distribution and periodic review. AI changes who writ…](https://qlogix.ai/blog/ai-document-management-validation-workflow)

## Other modules
- [Risk assessmentQuality risk management software for FMEA under ICH Q9(R1): design, process, equipment and CSV templates, RPN thresholds, mitigation tracked to residual risk.](https://qlogix.ai/products/quality-risk-management-fmea)
- [Regulatory submissionsRegulatory submissions software: post-approval changes screened per market, NDA and BLA sections drafted on an eCTD template, every claim quoted from its source.](https://qlogix.ai/products/regulatory-submissions)
- [LIMSLIMS for pharma QC laboratories: approved specifications, results judged by the system, OOS under investigation, calibration lockouts and a signed CoA.](https://qlogix.ai/products/lims)
- [Electronic lab notebookAn ELN for the QC laboratory: effective methods, equipment checked across LIMS, calibration and CMMS, observations never edited, results posted to the LIMS.](https://qlogix.ai/products/electronic-lab-notebook)
- [MES (electronic batch records)MES for pharma with electronic batch records: your master batch record, every step signed and verified, review by exception, ERP orders and QA release.](https://qlogix.ai/products/mes-electronic-batch-records)
- [GMP logbooksElectronic logbooks for GMP cleanrooms, equipment and instruments: system-stamped entries, second-person verification, never edited, periodic reviews signed.](https://qlogix.ai/products/gmp-electronic-logbooks)
[All 18 product pages](https://qlogix.ai/products)

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Source: https://qlogix.ai/products/document-control
QLogix · contact@qlogix.ai · +17146639012