AI compliance platform for life sciences that automates quality workflows and regulatory monitoring
Five ISO standards and one automotive QMS in a single workspace for gap diagnosis, document generation, compliance review and calculators
Stage
Not given
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Founded
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Based in
IE
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Pricing model
Contact for pricing
Freemium
Pricing
Foundation plan available; Growth plan available; Scale plan custom pricing. Annual recurring subscription model. All plans include cloud storage and platform updates.
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Key features
Document Control
Training Management
Supplier Quality Management
CAPA Management
AI-powered Gap Analysis
Compliance Intelligence with AI agents
Risk Management
Design Control Management
Change Control Management
Audit Management
60-second gap diagnosis with heat-map
Document generation for manuals, procedures and forms
Clause-by-clause compliance self-audit
Measurement uncertainty calculator with GUM and Monte Carlo methods
SPC control charts, MSA Gage R&R and process capability calculators
AIAG core tools including FMEA and PPAP for automotive
Environmental aspect and JHA/JSA risk matrices
Compliance calendar, CAPA tracker and document register
Integrated documentation for 9001, 14001 and 45001
2026 and 2029 transition packs for edition updates
What makes it different
80% less audit prep time
5x ROI in 2 months
AI agents automate regulatory monitoring across 28+ frameworks
Live within 30 days with expert-led implementation
Cross-map evidence once, reuse across submissions
All calculations and basic diagnosis are free with no sign-up required
One shared context across five standards eliminates duplicate work
Every generated item cites its standard clauses for auditability
User data stays local in browser; no files sent to servers
Not a certification body, so purely advisory preparation without audit authority
Qualio
LabKitPro