Agentic QMS: eQMS software for pharma, biotech and medical devices

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.