Description
Key Features and Benefits
- Audit Management – Conducts internal, supplier, and external audits, records findings, and tracks resolutions.
- CAPA & Complaint Handling – Logs and tracks Corrective and Preventive Actions (CAPA), manages customer complaints, and ensures compliance with regulatory requirements.
- Design Control & Document Management – Manages electronic Design History Files (DHF), document approvals, version control, and deviations.
- Supplier & Equipment Management – Tracks supplier approvals, calibration records, and maintenance schedules.
- Risk & Compliance Management – Implements hazard assessments, mitigation strategies, and regulatory reporting tools.
- Training & Certification – Tracks training completion, assessment tests, and certifications for compliance.
- Secure Data & Cloud Accessibility – Offers multi-site data backups, ISO 27001-certified hosting, and encrypted access control.
Key Differentiators
- Industry-Specific Compliance – Built specifically for medical device companies, with out-of-the-box regulatory workflows for ISO 13485 & FDA 21 CFR Part 11.
- Cost-Effective for Small Companies – More affordable than enterprise-level QMS solutions, making it accessible for startups and mid-sized businesses.
- Structured and Validated Workflows – Focuses on pre-configured compliance workflows, reducing the need for extensive customization.
- Cloud-Based Access – Ensures easy accessibility for remote teams while maintaining strong security measures.
