# Agentic QMS: eQMS software for pharma, biotech and medical devices
The QLogix Agentic QMS is an electronic quality management system (eQMS) that keeps change control, CAPA and controlled documents on the same audited, signed records as every other QLogix module. Every create, change, decision, signature, export and AI draft is an entry in one append-only audit trail, chained with SHA-256 for the organization, so a deviation, the CAPA it opened, the change control that carries the action and the procedure that changed are one connected file. The AI assesses changes, reviews CAPA plans and reviews document drafts, quoting its sources; people decide, and only people sign. A work queue shows every open record across the platform, what each one is waiting for and who owns it.
[Request a demo](https://qlogix.ai/contact)[All products](https://qlogix.ai/products)

## What the module does
- Change control from proposal to closure: an AI impact assessment across nine areas with the ICH Q9 risk and quoted evidence, tasks owned by function, a signed approval to implement, an effectiveness check and a signed closure.
- CAPA management: a CAPA opened from an approved investigation carries in the problem statement, root cause, classification and accepted actions; the AI reviews the plan for adequacy, gaps and extent of condition and proposes an effectiveness method, criterion and timeframe.
- A rule inspectors expect: retraining cannot be the only corrective or preventive action, and a plan that relies on it alone cannot be approved.
- Controlled documents with versions, numbered by type series (SOP, WI, POL, FRM, SPEC, PRT, RPT, MBR, DOC); the AI reviews each draft version, the findings are dispositioned, approval makes the version effective on its date, and trained people sign read and understood.
- Stages derived from what the record contains, never set by hand: a change control moves from Proposed to Assessed, Approved, Implementing and Closed; a CAPA from Plan to Plan approved, Implementing, Effectiveness check and Closed.
- A work queue of every open record across the platform (complaints, investigations, batch reviews, submissions, signals, change controls, CAPAs, documents and validation) with its stage, what it is waiting for, owner, due date and age, filtered by product or by what is overdue or due within 14 days.
- An overview of the risk posture: changes awaiting a decision, emergency or expedited changes open, CAPAs past their target date or awaiting effectiveness, and documents due for periodic review.
- Connected records linked by meaning (Originates from, Resulted in, Implements, Affects, Supersedes, Related to), shown from both sides, with suggestions of related records that share lots, equipment, documents, products or cause wording.
- An AI final review before any record is routed: the AI reads the change control, CAPA or document as the reviewers will and lists what to fix, where and how; the author decides what to accept.

## How it fits the platform
The Agentic QMS is the hub of the other modules rather than a separate system next to them. A complaint from Complaint handling or a deviation starts an investigation, and the approved investigation opens its CAPA prefilled; the CAPA raises the change control; the change control names the documents and training affected and the procedure is revised in document control; a change that may need a filing opens a regulatory impact screening in Regulatory submissions. Backlog triage ranks the open change controls and CAPAs by risk, Document management indexes every QMS document in one search, a modification in the CMMS goes through the same change control, and a validation project carries the reference of the change control behind it.
Because there is one record store and one audit trail, nothing is copied between systems to be reconciled later. Q Intelligence answers questions across every record with citations, and Q Agent works a goal across the QMS, proposing each action for a person to approve. Every record page shows the audit trail integrity check, and the read-only REST API and MCP server let other systems and AI assistants read the same records under an API key.

## Where people decide
The AI drafts: the change assessment, the CAPA plan review, the document review and the final review, each with exact quotes from the write-up or the attached documents. People choose every disposition, decision and route, with a reason when a value changes, and only people submit, review and approve, by electronic signature. The AI never signs, closes, releases a batch or decides reportability, and every AI draft is in the audit trail with the AI tool and model named.

## Where people decide
- Change controls, CAPAs and controlled documents are approved in review and approval cycles with an author, at least one reviewer and at least one approver, all different people, each signing with email and password.
- A CAPA plan needs at least one action and a defined effectiveness method and criterion before approval; retraining alone blocks it.
- Q Agent proposes actions and waits for a person's approval; nothing is ever signed or closed by an agent.

## Built to
- 21 CFR Parts 210 and 211
- 21 CFR Part 820 (QMSR)
- ICH Q9(R1) and ICH Q10
- 21 CFR Part 11 and EU GMP Annex 11
- EU GMP Chapters 1 and 4
- Draft EU GMP Annex 22 for the AI

## 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 Agentic QMS

### What is an eQMS?

An electronic quality management system (eQMS) is software that runs a manufacturer's quality processes, such as change control, CAPA and document control, as controlled electronic records with an audit trail and electronic signatures. The QLogix Agentic QMS is an eQMS for pharma, biotech, CDMOs, 503B facilities and medical device manufacturers, on the same records as the QLogix laboratory, maintenance and validation modules.

### What is an agentic QMS?

An agentic QMS is a quality management system in which AI agents work on the quality records themselves: assessing a change, reviewing a CAPA plan or a document draft, or working a goal across the system. In the QLogix Agentic QMS every agent action waits for a person's approval, records the agent creates start in review, and nothing is signed or closed by an agent.

### How is AI controlled in a GxP quality system?

In QLogix the AI only drafts, and each draft quotes the write-up or the attached documents it relies on. People decide every disposition and sign every approval with their email and password. Each AI draft, edit, decision and signature is an entry in the hash-chained audit trail with the AI tool and model named, so an inspector can see what the AI proposed and what a person decided.

### Does it support 21 CFR Part 11 and EU Annex 11?

It is built to support both. The audit trail is append-only and chained with SHA-256, changes to existing values need a reason, and an electronic signature re-enters the email and password and records the meaning, the time, the record version and a hash of the content. Signing locks after five wrong passwords in 15 minutes, sessions end after 15 minutes idle, and each organization's records are kept separate by the database.

### Can we migrate from paper or another QMS?

Controlled documents can be brought in: an administrator imports existing approved documents as their final approved PDFs, keeping the legacy document number, and signs the batch to attest that each file is the approved version. Each one becomes an effective controlled document, due for periodic review and revised like any other. The legacy import covers controlled documents; change controls and CAPAs are opened in QLogix.

### How is it licensed?

Per user per month, on its own or with other modules, ordered by purchase order from the client portal. Change control, CAPA and controlled documents are licensed together as the Agentic QMS. 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)
- [EU GMP Annex 22: what the draft AI annex asks of GMP manufacturersDraft Annex 22 is the first GMP annex written for AI. It allows static, deterministic models in critical GMP applications, keeps generative AI out of them, and asks for a defined i…](https://qlogix.ai/blog/eu-gmp-annex-22-ai-draft)
- [FDA's seven-step credibility framework for AI, in plain termsFDA's draft guidance asks sponsors to show that an AI model is credible for a specific context of use. The effort scales with model risk: how much the model's output drives the dec…](https://qlogix.ai/blog/fda-ai-credibility-framework)

## Other modules
- [Investigations and CAPAsCAPA software with deviation and OOS investigations: AI-drafted 5 Whys and fishbone, each cause tested as a hypothesis, CAPAs closed on an effectiveness check.](https://qlogix.ai/products/deviation-capa-management)
- [Complaint handlingComplaint handling software for pharma and medical devices: AI triage with quoted evidence, an adverse event check, a route set by QA and the investigation started.](https://qlogix.ai/products/complaint-handling)
- [Batch record reviewBatch record review software that reviews by exception: the AI lists only the exceptions with quotes, QA dispositions each one and signs the release recommendation.](https://qlogix.ai/products/batch-record-review)
- [Change controlChange control software for GMP: AI impact assessment in nine areas with ICH Q9 risk, tasks by function, signed approval to implement, effectiveness and closure.](https://qlogix.ai/products/change-control)
- [Document controlDocument control software for GMP: AI review of each SOP draft, signed approval on an effective date, read-and-understood training signatures and periodic review.](https://qlogix.ai/products/document-control)
- [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)
[All 18 product pages](https://qlogix.ai/products)

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Source: https://qlogix.ai/products/agentic-qms
QLogix · contact@qlogix.ai · +17146639012