AI that drafts quality records and governs itself.
Quality Copilot drafts descriptions, investigation summaries, CAPA plans, SOP redlines and review reports from the facts in the record, under AI governance designed around the draft Annex 22.
Quality Copilot is the AI drafting feature inside Cybroscape eQMS. It drafts deviation descriptions, investigation summaries, CAPA plans, SOP redlines and management review narratives from the facts already in the record, shows its basis, and leaves every decision and signature to qualified people. It is governed in the product's own AI register, designed around the draft EU GMP Annex 22.
QA time spent typing
A large part of QA time goes into writing up what is already known: the facts of an event, the evidence gathered, the plan agreed. It is necessary, slow and easy to get inconsistent across a site.
Drafts with their basis
Each draft is built from the record's own content and attachments and shows what it relied on, so the reviewer checks it against the facts rather than for plausibility.
Governed like any other GMP use of AI
Quality Copilot is registered in the product's AI governance register with its intended use, risk rating and human review requirements. Under the draft Annex 22, adaptive and generative models should stay out of GMP-critical decisions, and the product refuses that configuration rather than allowing an override.
What you get
What Quality Copilot delivers
Quality Copilot is part of the Cybroscape eQMS platform — an AI-native, agentic quality management system built for regulated Life Sciences. See how it fits with Document Control, Deviations and Investigations, CAPA Management.
- Drafts from the facts already in the record
- Shows what each draft was based on
- Never decides severity, root cause or release
- Registered and risk-rated under its own AI governance
Common questions
Prefer to talk first? Chat with us on WhatsApp or book a call with an expert.
Can we switch the AI off?
Yes. Every workflow works without AI drafting. Teams usually start with drafting on low-risk records and extend it as they gain confidence.
Is Annex 22 in force?
No. EU GMP Annex 22 is a consultation draft. Quality Copilot's governance is designed around it so you are not caught out when a final version is adopted.
Related capabilities
All capabilitiesWrite, review, approve and make effective SOPs, work instructions and forms, with periodic review dates and revisions opened automatically by the change that requires them.
Learn more about Document ControlDeviations and InvestigationsCapture deviations at the point they happen, classify severity, run the investigation with structured root-cause tools, and close only when the evidence supports it.
Learn more about Deviations and InvestigationsCAPA ManagementPlan corrective and preventive actions from the investigation, assign owners and dates, check effectiveness, and let the CAPA raise the change and the SOP revision it needs.
Learn more about CAPA ManagementChange ControlAssess, approve and implement changes with a risk-based impact assessment. Approved changes state their validation impact and pass it to GxP Copilot.
Learn more about Change ControlTraining and QualificationRole-based training matrices, assignments triggered by document changes, and a qualification check that stops someone with lapsed training from signing for GMP work.
Learn more about Training and QualificationSupplier QualityQualify suppliers, hold quality agreements and certificates, schedule audits, track supplier performance and let suppliers respond through a portal.
Learn more about Supplier QualitySources
Primary documents referred to on this page, from their official publishers.
- EudraLex Volume 4: EU Good Manufacturing Practice guidelines · European Commission
- Consultation on EU GMP Chapter 4, Annex 11 and draft Annex 22 (Artificial Intelligence) · European Commission
See quality copilot on your own data.
Bring a recent deviation or change. We show you how it runs end to end, from intake to closure.
- We reply within one business day
- We walk through your own records
- You get a clear migration plan