Description
Key Features and Benefits
- Quality & Compliance Management – Built-in support for ISO 13485, ISO 14971, and FDA QSR (21 CFR 820) compliance.
- Project Management Integration – Seamlessly links project management with quality and risk management.
- Automated Documentation & Version Control – Keeps track of all revisions, approvals, and regulatory submissions.
- CAPA & Risk Management – Automates corrective actions and risk assessments with traceability matrices.
- Traceability Matrix – Ensures full traceability for design controls and compliance audits.
- Collaboration Tools – Team messaging and real-time collaboration to streamline compliance efforts.
- Customizable Workflows – Drag-and-drop workflow editor to fit company-specific quality processes.
- Integration with Jira – Connects with Jira for Agile project management and regulatory compliance.
Key Differentiators
- All-in-One Compliance Solution – Combines quality, document, and risk management with project tracking.
- Pre-built Templates & Compliance Guidance – Step-by-step guidance for ISO 13485 and FDA 510(k) submissions.
- Audit-Ready Features – Automated quality manual, gap analysis reports, and full revision histories.
- Enterprise-Grade Security – Role-based access, QMS Vault, audit trails, and electronic signatures.
