Document design controls and automatically maintain full traceability.

Keep your documents, records, and procedures organized, up-to-date, and always accessible.

The only risk management solution that aligns with ISO 14971:2019 and integrates it throughout the quality ecosystem.

Conduct internal, external and supplier audits with ease.

Effectively manage your risk-based CAPA process in a connected ecosystem where inputs and outputs tell the true story.

Understand and manage the impact of any change.

Streamline the customer feedback and complaint risk-based processes that aligns with FDA regulations and ISO standards.

Reduce nonconformance cycle times and the risks associated with your nonconformance.

Ensure the right people receive training on the right things at the right time.