Corrective and preventive action (CAPA) is the central part of any quality system. Efficient CAPA management is in particular crucial for life science companies as well as other businesses doing dealing in regulatory environments. The overall attempt to investigate and correct superiority issues to avoid recurrence is very important not only to achieving regulatory compliance but also to overall product quality.

Maintaining compliance with internationally recognized regulatory requirements are unusually critical to success. With CAPA management software systems you can help improve product quality and safety thereby increasing customer satisfaction, and most significantly, ensuring compliance with regulatory principles.

Hundreds of businesses today around the world use CAPA management system to automate core business processes and document management performance to promote teamwork, improve decision making, and speed up time to market.

As a part of Orcanos QMS, Orcanos CAPA ensures regulations compliance and includes electronic, secured and centralized web-based system, corrective and preventive action management, prioritization, verification of effectiveness, workflow and e-sign automation and more. Integrated with ORCANOS e-QMS, it supports medical device compliance.

With vast years of proven experience in a regulated hi-tech industry, Orcanos is working with medical device manufacturers and other high-tech companies, assisting them in building their operational excellence. Their CAPA Medical Device customers manage to improve productivity and quality, streamline compliance with regulations such as ISO 13485, IEC 62304 and ISO 14971, and better comply with regulatory authorities such as FDA and CE. By using Orcanos smart dashboards and real-time alerts, the customers can keep track on their ongoing projects and have real-time visibity on their progress.

About Orcanos Software

Established in 2005, Orcanos Software is the only company that provides integrated software for ALM (Design Control) and quality management (QMS), combined with regulations compliance, and specialises in the medical device industry. Located in India and Israel, their R&D center creates and enhances the Orcanos ALM software tool, which they use to help customers implement their processes and methodologies.

For more information on CAPA management software visit https://www.orcanos.com/compliance/

Contact Information

8Beit Oved Street
Tel Aviv, Israel
+972-3-5372561
[email protected]