CAPA & 8D
Harmonized CAPA plus structured 8D with effectiveness checks.
ENTERPRISE QUALITY MANAGEMENT
Every quality decision,
with the evidence attached.
CAPA, deviations, change control, documents, training, audits, complaints and suppliers on one record graph.
Built as a multi-tenant QMS — not a document folder with workflows taped on. People stay in control of every regulated decision.
21 CFR Part 11 controls
ISO 13485
GxP workflows
Human-gated AI
THE QUALITY OPERATING SYSTEM
One connected system for every quality record.
The platform already runs CAPA and 8D, deviations, NCR, change control, complaints, audits, EDMS, training, supplier risk, eMDR and quality pulse — with AI that can suggest, not decide.
01CaptureComplaint, deviation, NCR or finding
02InvestigateEvidence, root cause, related records
03ActCAPA, change, document, training
04VerifyEffectiveness and e-signature
05LearnTrends, pulse and audit evidence
IN THE PRODUCT TODAY
Modules that share one record graph.
Deviations & NCR
Triage impact and flow into CAPA without re-keying.
Change Control
Impact assessment that pushes document and training updates.
EDMS
Approved revision on the floor. Next rev stays in QA draft.
Training
Assignments fire when a controlled document changes.
Complaints
Intake to investigation, reportability and linked CAPA.
Audits
Program planning, findings and evidence that become actions.
Supplier risk
Qualification, issues and SCARs with scoped partner access.
eMDR / watch
Regulated reporting and regulatory watch beside the QMS.
AI insights
Similar records, draft summaries. Cannot sign or close.
See AI →CAPA WORKSPACE
The record stays connected to evidence, documents and training.
Open a CAPA and see source complaint, linked SOP, training impact, SLA and e-signature status on the same screen. AI can point to similar events. Only an authorized user can sign.
DOCUMENT CONTROL
The floor only sees the approved revision.
QA can draft the next version while operators keep working from the current approved SOP. Change, training and CAPA links sit on the document, not in a side spreadsheet.
AI QUALITY INTELLIGENCE
Ask the system what the evidence says.
Natural-language search across connected records. Suggest a category, flag a likely duplicate, draft a summary. AI cannot approve, sign or close a record.
COMPLIANCE & GOVERNANCE
Designed for controlled execution.
Controls and evidence support your validation program. Intended use is yours to define.
21 CFR Part 11Named users, e-signatures and audit-trail-oriented history.
ISO 13485 / 9001Process design for medical-device and quality systems.
RBAC + tenancyMulti-tenant kernel with role and record-type access.
Validation packIQ / OQ / PQ evidence support on request.
FAQ
Questions quality teams ask first.
Can we start with one process?
Yes. Start with CAPA, documents, complaints or audits and expand on the same tenant.
Does this match our SOP?
Yes. Delivered record types and workflows are configurable — fields, states, rules and approvals.
How is AI kept in bounds?
Suggestions are reviewable. Authorized users remain responsible for dispositions and signatures.
Do you support validation?
Yes. An IQ / OQ / PQ evidence pack is available. ElarisQ does not replace your validation responsibility.