Documents live in email threads while auditors ask for evidence you cannot find.
47 minavg. evidence hunt
Built for regulated teamsOne system to manage
One system to manage
quality and compliance
Documents, audits, CAPA, suppliers, and reporting — unified for teams under ISO, IATF, and AS9100.
Compliance standards
ISO 9001IATF 16949AS9100FDA 21 CFR Part 11GMPISO 13485
40%
Faster audit preparation
98%
Document control compliance
3×
Quicker CAPA closure
24/7
Quality Assistant availability
The challenge
The standard isn't the hard part.Everything around it is.
Quality teams lose days to scattered records, manual follow-ups, and audits that arrive before issues are truly closed.
NCRs and CAPAs sit in spreadsheets with no clear owner or due date.
38%CAPAs past due
Supplier issues, training gaps, and shop-floor findings never connect in one view.
6+ toolsdisconnected systems
How AI-QMS helps
One platform across your quality journey
Document control
Keep every SOP, WI, and record under control
Centralize controlled documents with version history, approval workflows, and review dates—so teams always work from the right revision.
- Draft, review, approve, and archive in one workflow
- AI classification and risk scoring on upload
- E-signature readiness for Part 11 environments
Audits & CAPA
Close the loop from finding to fix
Plan audits, log findings, open NCRs, and drive corrective actions without losing context between quality events.
- Internal, external, and supplier audit tracking
- NCR severity, root cause, and corrective action fields
- CAPA priority pipeline through verification
Quality Assistant
Answers when your team is buried in audits
Ask about open NCRs, upcoming audits, document status, or supplier risk—and get guidance grounded in your quality data.
- Natural-language queries across modules
- Context-aware recommendations for next steps
- Always available for after-hours coverage
Your workflow
From detection to closure
Every issue follows a clear path—no more dropped handoffs between NCR, CAPA, and audit evidence.
Catch issues before they escalate
Non-conformances, complaints, SPC signals, and gemba observations feed one quality picture.
Non-ConformanceComplaintsSPCGemba Walks
Understand root cause with full context
Link documents, audit findings, supplier data, and risk scores to every investigation.
AuditsRiskSuppliersDocuments
Close CAPA and prove effectiveness
Track corrective actions, training completion, and regulatory reports through closure.
CAPATrainingRegulatoryKaizen
Features
Everything auditors expect, in one place
Document control, audits, CAPA, suppliers, training, SPC, and regulatory reporting—each with its own dashboard, workflows, and intelligence layer.
Document control through CAPA
The foundation every audit expects—controlled, traceable, and connected.
Documents
Version control & approvals
Audits
Findings & closure tracking
Non-Conformance
NCR lifecycle management
CAPA
Corrective & preventive actions
Intelligence
AI that understands quality work
Not generic chat—contextual assistance inside documents, audits, and your daily quality decisions.
Quality Assistant
Your always-on quality expert
Answers compliance questions, surfaces open issues, and suggests next actions.
Document Analyst
Inside every controlled file
Classifies documents, summarizes content, and flags risk before approval.
Audit Advisor
Prepares you for every audit
Helps plan checklists, review findings, and prioritize closure activities.
Get started
Up and running in minutes
1
Create your workspace
Sign up and configure your organization profile.
2
Activate your modules
Turn on documents, audits, CAPA, and the workflows you need.
3
Run quality with confidence
Invite your team and let AI-QMS handle the operational load.
Frequently asked questions
Pharma, medical devices, automotive, aerospace, and general manufacturing teams operating under ISO 9001, IATF 16949, AS9100, GMP, or FDA Part 11 requirements.