Why CAPA Medical Device Is So Important For Your Organization?

CAPA Management Software

If you are a quality professional who wants to achieve greater quality in manufacturing then you need to know that Corrective and Preventative Actions (CAPA) are very important elements of quality management, process discipline and continues improvement. Without consistent and strong CAPA processes, as a quality professional who operates in a federally regulated industry such as life science, you cannot achieve myriad and compliance to ISO 9001 and other quality standards.

What Is a CAPA System? Why You Need It?

CAPA is the most essential and commonly used tool in quality management. This tool is used for the process of mitigating and identifying non-conformances and deviations both externally and internally and it consists of two essential key elements such as corrective actions and preventative actions. When these two aspects of CAPA System used together effectively, then it reinforces and complements one another to improve quality. Corrective action is a process you initiate to respond to an identified non-conformance such as supplier defect, or fabricating a part based on an obsolete specification, or an uncalibrated gauge through root cause analysis. There is a common misconception among people that preventative actions only represent the follow-up steps to corrective actions but you need to know that preventative action process seeks to avoid occurring of potential non-conformance in the first place which can affect the quality at a future date.

If you own a manufacturing industry then one of the main reasons why you need to have CAPA Medical Device is that this process offers a lot of benefits of identifying potential and current quality issues as soon as possible during production. As a quality professional, you might already know that in quality management the cost of quality rises as defects surface closer to the customer. Having a CAPA system in your organisation helps you to prevent costly mishaps from reaching the consumer. Orcanos is the most reputable company that have many years of experience offering the best CAPA Medical Device that is fully secured, centralised web-based and electronic system. We have designed a CAPA system in such a way that ensures regulations compliance, while completely automating the CAPA process from investigation to initiation and closure.

Orcanos CAPA System includes best corrective and preventive action management, root cause management and action planning, prioritization, verification of effectiveness and traceability feature to other quality processes such as ECO, FMEA, Complaints, Training, Verification etc. The FMEA i.e. Failure Mode and Effect Analysis has become an essential procedure for determining where products, processes or designs are most likely to fail and its reasons to fail. Orcanos designed best FMEA Medical Device to those businesses that are increasingly looking for more precision to solving their risk management challenges.

For more details & information to know about Orcanos please visit our website here: https://www.orcanos.com/compliance/