Top Reasons Why Your Organization Should Have CAPA Management Software?

1. Top Reasons Why Your Organization Should Have Top Reasons Why Your Organization Should Have CAPA Management Software? CAPA Management Software? Corrective and preventive action also known as CAPA is the core of any quality system which focuses on the systematic investigation of the root causes of identified risks and problems in an attempt to prevent occurrence. The CAPA are improvements to a company or organisation’s processes taken to eliminate risks and causes of waste and defects. When supported by technology, CAPA programs are also the most effective ones just like any other continuous improvement approach. The success of CAPA implementation mainly depends upon the ability to use them to identify performance non- conformities and on an understanding of KPIs. The corrective and preventive action software helps ensure that each and every identified problem or risk is addressed completely and quickly. The issues such as repetitive or critical nonconformities, equipment problems, process efficiency issues, incomplete procedures, complaints or audits can trigger CAPA work and all these things are most likely to be first noticed by Frontline employees. This is the reason effective CAPA management is important especially for life science organisation and other companies doing business in regulatory environments. Today, many organisations use CAPA software which makes it easy for any employee to identify and report a problem or risk. Orcanos offers best CAPA management software and system for automating corrective action process in regulatory environments. Orcanos CAPA software ensures regulations compliance, along with complete automation CAPA process from initiation to investigation and closure.

2. For any organisation maintaining compliance with a globally recognised regulatory environment are very critical to success. When CAPA management system is implemented properly, the customer satisfaction increases, your company can enhance product safety and quality and most importantly ensure compliance with regulatory standards. The Orcanos CAPA management system includes: • A secured, electronic and centralized web-based system, • Corrective and preventive action management, • Action planning and root-cause management, • Smart dashboards, • Prioritization, • 21 CFR Part 11 complaint, • Workflow and e-sign automation, • Tractability to other quality processes such as complaints, training, verification, FMEA, and ECO etc. If you have a medical firm and if you are really new to the medical device development Industry then it can become a bit overwhelming trying to figure out which path to take and what actually CAPA mean. FDA has always expected regulated Industries to perform corrective and preventive actions by establishing a unified CAPA medical device system for marketing products in their country. At Orcanos, our medical device customers manage to improve quality and productivity as well as

3. streamline compliance with regulations such as ISO 13485, ISO 14971 and IEC 62304 and better comply with regulatory authorities such as CE and FDA. By using Orcanos real-time alerts and smart dashboards, our customers can keep track of their ongoing projects and can also have real-time visibility on their progress. For more information and details to know about Orcanos please visit our website here: https://www.orcanos.com/compliance/ Contact Information 8Beit Oved Street Tel Aviv, Israel +972-3-5372561 info@orcanos.com