Improve your delivery time by utilizing software that integrates Application Lifecycle Management (ALM) and regulated Design Control.
With Orcanos ALM Requirements tool, you can easily plan, approve, trace, and validate industry requirements, manage audits, and ensure regulatory compliance.
Integrating Risk Management into your development process can prevent failure and save up to 30% of resources. Generate a Risk Management file that is fully compliant with ISO 14971 standards with one click.
Streamline verification and validation processes in a single ALM platform. The Test Management tool tracks and analyzes results in digital formats, including Word, PDF, and Excel.
The Defect Tracking system enables project participants to submit, query, and export product issues throughout the development lifecycle.
Achieve full compliance with MDR for post-market and market surveillance. Easy to use, configured, and fully integrated with quality management and design control.
Simple and powerful traceability matrix management between any ALM or QMS artifact.
Orcanos ALM system provides a single data repository that combines research and development, quality management and compliance regulations. This means that companies can manage all required elements – testing, risk management, CAPA, and change management, all in one place.
System includes a simple and powerful tool – Traceability Matrix Management – that allows interaction between any ALM or QMS artifact during the process. This includes but is not limited to project requirements, test cases, FMEA risk items, CAPA and customer complaints.
The product database can be displayed using various customizable templates that can include tables, visual images, and dynamic data sets embedded within them.
Orcanos will issue notifications to end users when any change impact is detected via our filters and alerts mechanism.
The system is powerful and comprehensive, providing support for medical device companies. Despite its complexity, the solution is simple to apply, connect, and operate.