The Corrective and Preventive Action also known as CAPA is the most important tool that is utilized by many organizations worldwide to identify, avoid and resolve non-conformances. CAPA also defined as the improvements made to an organization’s processes taken to eliminate causes of undesirable situations and non-conformities. In an attempt to prevent their recurrence for corrective action or preventive action, it focuses on the systematic investigation of the root causes of identified risks or problems. Just the way it sounds, the CAPA management system consists of two main elements that are corrective and preventive action and both these actions have one main aim that is to improve the quality of processes. Although CAPA processes have been employed by many organizations all over the world, they have been evolved correspondingly with the advancement in the new technologies and strategies.
Today, it has become a common tool to be integrated with many applications in IT architecture and it also plays a very crucial role in the global quality management system initiatives. According to the report, it is said that in the recent year, more than 83% of warning letter has been cited CAPA as an area of non-compliance at FDA regulated organizations or companies, even though most of these organizations were noncompliant in one or more areas such as CAPA purchasing controls or process validation requirements. So, by considering the above factors, it is clear that organizations need to have a specialized robust software application for CAPA management system or an electronic quality management system (eQMS). In this article, we will discuss the main elements of Orcanos CAPA system is integrated with ORCANOS e-QMS to support medical device compliance.
Orcanos is one of the leading and most reputable company that have many years of experience providing complete automation of the CAPA process in Orcanos quality management system (QMS). As part of Orcanos QMS, Orcanos Corrective Action and Preventive Action (CAPA) ensure regulations compliance while completely automating CAPA process from the beginning stage that is an initiation to investigation and closure. Orcanos CAPA Management Software includes the most secured and centralized web system and also have traceability to other quality processes such as FMEA, verification, ECO, Complaints, Training etc. Today, the first-in-first-out methodology for CAPA has been used to reduce non-conformances and this is the reason, it is becoming more common for many companies worldwide to integrate CAPA and non-conformance reporting modules with electronic quality management system (eQMS) and many QMS solutions have this built-in capability.
In order to support medical device compliance, Orcanos CAPA system is integrated with Orcanos e-QMS. No matter whether it has risk associated or a resolution requires an engineering change, Orcanos links the quality management artefacts using traceability tool and strives to provide impact analysis and better tracking. To know more details and other information about ORCANOS please visit our website here: https://www.orcanos.com/compliance/