AiQMS — quality management that reads, runs and proves your SOPs.
Most QMS tools are filing cabinets with extra steps. AiQMS is different: it ingests your SOPs, runs the workflows, watches your data for deviations, and assembles audit-ready evidence — automatically.
Most QMS tools store quality. AiQMS runs it.
Traditional QMS asks humans to manually log everything, then hope nothing falls through the cracks. AiQMS reverses that: it watches your data streams, detects when reality drifts from your SOPs, and assembles the paperwork before you ask for it.
- →Reads your existing docs. Drop in your Word SOPs, Confluence pages, even photos of laminated wall posters. AiQMS extracts every requirement.
- →Watches your data. Connects to your ERP, MES, lab system, IoT sensors. Flags deviations the moment they happen — not the day before audit.
- →Runs CAPA on autopilot. Auto-assigns owners, sets deadlines, escalates breaches, closes the loop with evidence.
- →Audit-ready in two clicks. ISO 9001, 13485, 27001, IATF 16949 evidence packs assembled automatically. Hand to your auditor. Walk out clean.
From dusty SOP folder to live quality system in 7 days.
Ingest
Upload SOPs, work instructions, forms. AiQMS extracts every requirement, owner and trigger.
Connect
Plug into your ERP, MES, lab system, sheets, sensors. We support 60+ integrations out of the box.
Watch
AiQMS continuously checks reality vs SOPs. Deviations trigger CAPAs the moment they happen.
Prove
Audit room assembles the evidence pack. PDF, signed, timestamped, ready for your registrar.
The view your quality lead checks every Monday.
Regulated industries that can't afford a non-conformance.
Medical devices
ISO 13485, FDA 21 CFR 820, MDR — built-in templates and pre-mapped workflows.
Pharma & biotech
GMP, GxP, batch records, deviation logs and CAPAs. e-signature ready.
Food & beverage
HACCP, BRCGS, SQF. Sensor-fed temperature logs, traceability records, audit packs.
Manufacturing
ISO 9001, IATF 16949. PPAP, FAIR, and full APQP cycle support.
Software & SaaS
ISO 27001, SOC 2 Type II. Continuous control monitoring, evidence collection, policy attestation.
Different industry?
If it's regulated, we can support it. Tell us your standard, we'll map it.
Lock in launch pricing before Q2.
Waitlist members get 30% off year one and front-of-line access to the beta.
Single-site teams. One standard.
- Up to 50 SOPs
- 1 ISO standard
- Basic CAPA workflows
- Audit room export
Multi-site. Multiple standards. AI on.
- Unlimited SOPs
- Up to 3 standards
- Full CAPA + risk register
- ERP / MES / lab integrations
- AI deviation detection
- Auditor portal
Validated env. Dedicated tenant.
- Validated GMP environment
- 21 CFR Part 11 e-signatures
- SSO, audit log, retention rules
- Dedicated CSM + onboarding
- SLA, DPA, BAA available