Today, compared to any other area of quality management, CAPA is causing more compliance troubles for life sciences companies or organizations. According to the recent reports, nearly more than 83% of the warning letters are cited CAPA as an area of non-compliance even though most of the organizations were non-compliant in one or more areas. By considering the above factors, it is clear that your organization need a specialized software application for the management of CAPA because in most of the cases when an organization receive a warning letter, it means that the technology was in place but it failed for one or another reason.
But What Is CAPA Management?
The term CAPA stands for “Corrective Action and Preventative Action” and the main purpose of the system is to collect information, identify, analyze information and investigate product and quality problems and take appropriate and necessary action plan to prevent their recurrence. The CAPA management system also helps to verify or validate corrective and preventive actions as well as communicating the activities to responsible people by providing relevant information for management review. And then documenting all these activities is also very important if you want to deal effectively with quality and product problems and to minimize device failures and prevent their recurrence.
However, today even the paper-based, home-grown or commercially available electronic management systems may meet minimum requirements of FDA. But as a business owner, if you want your organization to go further than just checking the box and want to capture and expand your market share then you have come to the right place. Orcano's CAPA MANAGEMENT SOFTWARE is a well designed comprehensive yet easy to use software system which is used to effectively manage your organization’s corrective action and preventive action processes while integrating with other processes. Managing these processes is very important in order to regulatory compliance such as change control, non-conformance, audits and customer complaints. As part of Quality Management System (QMS), Orcanos CAPA management software ensure regulations compliance, while completely automating process right from the initiation to investigation and closure which will greatly help you get more business.
Here are some of the following features of Orcanos CAPA system which includes:
- Best Corrective and Preventive Action Management
- Secured, centralized and electronic web-based system
- Traceability matrix to various quality processes such as FMEA, Training, Verification, ECO, Complaints etc.
- Prioritization
- Smart dashboards
- Action planning and root-cause management
- 21 CFR Part 11 compliant
- E-sign automation and workflow
Orcanos is one such platform which can help your business to convert each and every issue into an opportunity for improvement. And our highly designed Orcanos CAPA management software system is integrated with Orcanos e-QMS to support medical device compliance.
To know other details & information about ORCANOS please visit our website here: https://www.orcanos.com/compliance/
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