Cybroscape eQMS
An agentic quality management system for pharma, biotech and medical devices.
Cybroscape eQMS runs document control, deviations, CAPA, change control, training, suppliers, complaints and audits in one connected system. AI drafts the records and finds the links between them; qualified people review, decide and sign.
Cybroscape is trusted by life sciences teams worldwide
One quality system where every record knows what caused it.
Most quality systems store records. Cybroscape eQMS also connects them. A deviation opens its investigation, the investigation feeds the CAPA, the CAPA raises the change, and the change opens the SOP revision and tells validation what needs re-testing — each step with its own review and signature. Quality Copilot drafts deviation descriptions, investigation summaries, CAPA plans and SOP updates from the facts already in the system, so QA spends its time deciding rather than typing. Built for 21 CFR Part 11 and EU Annex 11, with AI governance designed around the draft EU GMP Annex 22.
Deviation, investigation, CAPA, change and SOP revision are one chain, not five separate forms that someone has to keep in step.
Quality Copilot drafts from the facts in the record. Nothing becomes effective without a qualified reviewer and a Part 11 signature.
An approved change states its validation impact and hands it to GxP Copilot, so the validated state is assessed rather than assumed.
Lapsed training blocks a signature, a major deviation cannot close without a concluded investigation, and averaging cannot hide a failing result.
Every AI use is registered and risk-rated, designed around the draft Annex 22. An adaptive model is never placed in a GMP-critical decision.
See it working.
Real screenshots from Cybroscape eQMS — the quality dashboard, connected records, your work queue and quality reviews.
From a deviation to a trained team, in one chain
Six linked steps. Each one opens the next when it is committed, and every decision has a named signature.
A clear deviation description drafted from the facts entered at intake, with the batch, equipment or system it touched.
QA classifies severity and records the rationale.
The Cybroscape eQMS capability stack
Every capability has its own page, written for search and generative engines alike. Pick one to see how it works.
Write, 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, investigations and root causeDeviations 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 InvestigationsCorrective and preventive actionCAPA 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 control with validation impactChange 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 matrix and qualificationTraining 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 qualification and monitoringSupplier QualityQualify suppliers, hold quality agreements and certificates, schedule audits, track supplier performance and let suppliers respond through a portal.
Learn more about Supplier QualityComplaints, OOS and reporting clocksComplaints and OOSLog complaints with reportability assessment and the right clock, and manage out-of-specification results with the averaging rule fixed before the answer is known.
Learn more about Complaints and OOSAudits, inspections and management reviewAudits and Inspection ReadinessPlan internal and supplier audits, manage findings, prepare for inspections with a regulation crosswalk, and run management review and APQR from live data.
Learn more about Audits and Inspection ReadinessAI drafting and AI governanceQuality CopilotQuality 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.
Learn more about Quality CopilotEverything a quality head asks before buying
Why Another eQMS
The established eQMS platforms are mature, configurable and widely used, and for many large organisations they are the right choice. The gap we see is elsewhere: in the hours between the records. A deviation is logged in one place, the investigation is written in a document, the CAPA is raised separately and the SOP change is tracked on a spreadsheet. The system holds every piece; a person holds the connections.
Cybroscape eQMS is built around those connections. Each record knows what caused it and what it caused, and the next step opens when the previous one is committed. That is where the time goes in most quality teams, and it is where most inspection findings come from: an action that was agreed and never closed, or a procedure that was meant to change and did not.
Where the AI Helps, and Where It Stops
Quality Copilot drafts the parts of quality work that are writing rather than judgement: the deviation description from the facts captured at intake, the investigation summary from the evidence attached, a CAPA plan in your format, the redlined SOP text after a change is approved. Each draft shows what it was based on.
It does not classify severity, decide root cause, approve a CAPA or release a batch. Those decisions belong to qualified people and the system records who made them. Under the draft Annex 22, an adaptive or generative model should not sit in a GMP-critical decision path, and the product enforces that for its own AI rather than leaving it to procedure.
21 CFR Part 11 and EU Annex 11 Controls
Every record has an attributable, time-stamped and tamper-evident audit trail. Electronic signatures require re-authentication and record the meaning of the signature. Authors cannot approve their own records, and signed versions cannot be silently edited — a correction creates a new version with its own approval.
No regulator certifies software as compliant. What a vendor can do is make the controls real and easy to show an inspector; the validated state belongs to your implementation and your intended use.
Built for Pharma, Biotech and Medical Devices
The core covers GMP quality processes: documents, training, deviations, investigations, CAPA, change control, risk under ICH Q9(R1), suppliers, complaints, out-of-specification results, audits, management review and the annual product quality review.
For device manufacturers there is a device pack aligned to ISO 13485, ISO 14971, the FDA QMSR and EU MDR: design controls with full traceability, device classification per market, and complaint handling that starts the right reporting clock.
Moving From Your Current System
Most teams arrive with an existing system or a set of controlled documents and spreadsheets. Migration brings across documents with their version history and open records with their status, so you do not start the new system with a backlog of re-entry.
Single sign-on, user provisioning and a read-only API are available for teams that need the eQMS to sit inside an existing IT estate.
Sources
Primary documents referred to on this page, from their official publishers.
- 21 CFR Part 11: Electronic Records; Electronic Signatures · eCFR (US)
- Quality Management System Regulation (QMSR) · US FDA
- EudraLex Volume 4: EU Good Manufacturing Practice guidelines · European Commission
- EU GMP Annex 11: Computerised Systems (current version) · European Commission
- Consultation on EU GMP Chapter 4, Annex 11 and draft Annex 22 (Artificial Intelligence) · European Commission
- ICH Quality guidelines (Q9(R1), Q10, Q12 and others) · ICH
- ISO 13485:2016: Medical devices quality management systems · ISO
Product plus the team that runs it
Cybroscape eQMS FAQs
The questions we get before every first call, answered plainly. Prefer to talk first? Chat with us on WhatsApp.
What does Cybroscape eQMS cover?
Document control, training, deviations and investigations, CAPA, change control, risk under ICH Q9(R1), supplier quality, complaints, out-of-specification results, audits, management review and the annual product quality review, with a device pack for ISO 13485, ISO 14971, the FDA QMSR and EU MDR.
What makes it agentic?
Records connect and move forward on their own: a committed deviation opens its CAPA, a committed CAPA raises its change control, an implemented change opens the SOP revision and retraining. Quality Copilot drafts the write-ups. Every decision and signature stays with qualified people.
Is it 21 CFR Part 11 and Annex 11 ready?
Yes. Tamper-evident audit trail, re-authentication at signing with the meaning recorded, segregation between author and approver, and version control that never edits a signed record. Your validated state still depends on your implementation and intended use.
How does it work with GxP Copilot?
Approved changes to computerised systems carry their validation impact into GxP Copilot, which proposes the re-testing needed. Supplier assessments can be shared in the same way. Each product also works on its own.
Can we migrate from our current system?
Yes. Documents come across with their version history and open records with their status. Single sign-on, user provisioning and a read-only API are available.
See Cybroscape eQMS run 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