Running a successful company or organization requires more than simply offering a product or service that the market needs. To be successful an organization must have the right policies in place to monitor a variety of potential issues ranging from customer complaints to audits and even changing procedures. One way of staying abreast of both issues and their solutions is to put in place a CAPA system.
CAPA stands for Corrective and Preventative Action. It is a part of the Quality Management System (QMS) and is one of the key elements of a management system that is directed towards continuous improvement and customer satisfaction. CAPA a comprehensive plan which enables a company to identify problem areas, devise and implement solutions and closely monitor the situation to ensure that the issue has been properly dealt with and corrected.
While this system is applicable across many industries; CAPA in the Pharma and medical industries is deemed much important. Any company manufacturing or selling any medical devices or pharmaceutical products must follow the CAPA guidelines very carefully, or risk losing their licenses by FDA mandate.
CAPA System - Why Is It Necessary?
The benefits of having a CAPA Management System in place include a solid methodology for identifying and correcting problems as well as thorough documentation of every step that is taken. A company will be able to thoroughly assess whether or not the actions are taken to correct the matter were effective and appropriate by reviewing all of the steps that were taken along the way. This type of system allows a company to operate more efficiently and to deal with problems effectively. It is difficult to overstate the importance of documenting both the causes and steps taken to prevent an issue in this age of increased competition and litigation
For effective CAPA, Orcanos Software comes into existence in the year 2005 by Zohar Peretz and Rami Azulay. Orcanos is the only company that provides integrated software for ALM (Design Control) and quality management (QMS), combined with regulations compliance, and specializes in the Medical Device industry.
The unique thing about us is our years of proven experience in a regulated hi-tech industry, working with CAPA Medical Device manufacturers and other high-tech companies, and assisting them in building their operational excellence. Moreover, our years of experience and knowledge, provide us the ability to tailor custom solutions and sets Orcanos apart from other vendors and consulting bodies in the ALM and quality management domain.
In brief CAPA software systems can track the progress of correction required through workflows while maintaining records of all reported problems and actions in a system database.
To know more about Orcanos and the products or more please, call us at+972- 3-5372561 or visit our website HERE; https://www.orcanos.com/compliance