Description
Key Features and Benefits
- Document Management – Centralized document storage with role-based access control.
- CAPA (Corrective and Preventive Actions) – Automates non-conformance tracking and root cause analysis.
- Training Management – Assign role-specific training and track completion.
- Change Management – Streamline change control approvals with electronic signatures.
- Audit & Compliance Management – Automates internal and external audit tracking.
- Risk Management – Complies with ISO 14971 for risk assessment and mitigation.
- Electronic Signatures & Audit Trails – Full compliance with FDA 21 CFR Part 11 for traceability.
Key Differentiators
- Built for Life Sciences – Designed for medical devices, biotech, pharma, and regulated industries.
- Modular & Scalable – Choose from 3-10 modules based on company size and needs.
- Superior Customer Support – Customizable training and onboarding assistance.
- Affordable & Transparent Pricing – Flexible pricing based on user count and selected modules.
- Cloud or On-Premise Deployment – Allows companies to host on AWS cloud or internally.
