The agentic eQMS that keeps a human in every GxP loop
Deviations, investigations, root-cause analysis, CAPA, change control, documents, training and audits live in one intelligent platform. AI brings structure and speed, and qualified people make every decision.
Investigations that hold up
AI brings structure to deviations and CAPA without blurring the line between narrative and the validated system of record.
Agentic investigations
Parse the narrative, fetch context, summarise evidence, check data integrity, then draft the RCA and CAPA.
AI triage at intake
Suggested codes, criticality and reportability on every intake form.
Similar-event detection
Semantic matching against past records, with a match percentage, to catch recurrence early.
Ask your QMS
Multi-turn chat across documents, SOPs and quality records, with citations.
Predictive quality
A 0–100 risk score with reasons for every open record, and spikes shown as emerging signals.
AI audit-trail review
Flags ALCOA+ anomalies: changes without a reason, deletions, after-hours edits and bursts of edits.
Regulatory gap analysis
Checks controlled documents against 21 CFR 820/QMSR, EU Annex 11 and ICH Q10: covered, partial or gap.
No-code configuration
Codelists, custom fields, quality groups, risk formulas, numbering, notifications and schedulers.
Report builder
Templates built from sections and fields, with Excel and PDF export, and exports are audited too.
A complete quality ecosystem
Record and investigate
- Deviations & incidents
- Quality issues & NCR
- OOS results
- Complaints & recalls
- Investigations
Correct and improve
- CAPA with effectiveness checks
- Change requests
- Risk management (RPN)
- Batch release
- Periodic review
Govern and prove
- Document management & versions
- Training, certificates & badges
- Audits & suppliers
- Regulatory intelligence
- My tasks, alerts & messages
A CAPA loop with accountability built in
Record
Create the deviation, attach evidence, and let AI suggest codes and criticality.
Investigate
Assign an investigator. The AI analysis drafts the root cause, and a person reviews it.
Approve & act
E-signed approval, then CAPA carried out by the owners assigned to it.
Verify & close
Effectiveness is verified before closure, and everything lands in the audit trail and dashboard.
Signatures and an audit narrative you can defend
Designed around 21 CFR Part 11, EU Annex 11, GxP and ALCOA+, with the FDA and EMA AI guidance in mind.
Part 11 e-signatures
Password and reason for every controlled action, with configurable reason text.
Central audit trail
Every change, export and signature, searchable in one viewer.
Multi-site operations
Filter by organisation, site, module and date, with folder-level access by role, group or user.
Validation support
IQ/OQ/PQ documentation to support your computer system validation.
Agentic investigations, human sign-off
An agent pipeline parses the narrative, gathers context, checks data integrity and drafts the root cause and CAPA. Qualified people approve every decision.
Agentic RCA & CAPA
Parse, gather context, summarise evidence, check integrity, draft RCA and CAPA.
Similar-event detection
Semantic matching against past records, with a match percentage.
Predictive quality
A 0–100 risk score with reasons, and spikes shown as emerging signals.
AI audit-trail review
Flags ALCOA+ anomalies such as changes without a reason or edit bursts.
Explore the connected suite
Quality intelligence your teams can stand behind
See an AI-assisted investigation go from deviation to an e-signed CAPA in one walkthrough.