Description
Key Features and Benefits
- Pre-Validated System – FDA 21 CFR Part 11, GxP, ISO 13485, MDR, and ICH Q10 compliance out of the box.
- Automated Document Control – Versioning, electronic signatures, and approval workflows with Microsoft Office 365 integration.
- CAPA and Change Management – Closed-loop tracking of corrective actions, non-conformances, and change controls.
- Training Management – Automated training assignments, tracking, and compliance reporting.
- Audit and Supplier Management – Track suppliers, schedule audits, and manage regulatory inspections.
- Real-Time Dashboards & Analytics – Automated KPI reports for compliance monitoring.
- Highly Secure Cloud Storage – Microsoft Azure-based infrastructure with 15-minute backups.
Key Differentiators
- Turnkey Implementation – Pre-configured workflows minimize setup time.
- Scalability & Flexibility – Suitable for small and medium-sized life science organizations.
- High Customer Support Ratings – 24/7 support and dedicated project managers.
- All-Inclusive Pricing – Flat-rate subscription with no hidden fees.
