AI-powered electronic quality management system for life sciences
Stage
Not given
Established
Founded
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2015
Based in
US
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Pricing model
Freemium
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Pricing
Free trial: 14 days, $0, includes 5 AI sample tests and 50 manual tests. Starter: $99 first month, then $279/month, includes 25 AI sample tests monthly and unlimited manual testing. Professional: $799/month, includes 80 AI sample tests monthly, year-end package and external auditor package. Enterpri
Not given
Key features
Risk and Control Matrix import
Evidence file matching and organization
Multi-entity control management
Deficiency tracking and remediation
Role-based access control
Year-end SOX 404 reporting
Automatic deficiency creation from exceptions
Segregation of duties enforcement
Document Management
CAPA Management
Change Management
Training Management
Audit Management
Quality Event Management
Supplier Quality Management
Risk Management
Electronic Batch Record
Complaint Management
What makes it different
AI shows its work with exact quote and page citations on every verdict
Hash-chained audit trail that auditors can verify independently
Evidence never used to train AI models
All steps locked and recorded from population upload to signed-off test
Consolidates entire SOX testing workflow in one workspace instead of spreadsheets
Industry's first AI-powered eQMS specifically trained on quality management workflows
Pre-built and pre-validated solutions with rapid deployment capability
Built natively on Salesforce for security, scalability and integration
Modular platform allowing organizations to start small and scale
Deep domain expertise in life sciences quality and compliance
SOXLayer