CQMS - purpose-built electronic QMS
In partnership with Origami, citoQualis has developed a purpose-built eQMS tailored to medical device manufacturers. The software entails all the QMS modules necessary for compliance, and can be extended with other business modules, such as CRM, project management, HR etc. as the company grows.
The cQMS is a tool configured in simple and straightforward manner that facilitates compliance with ISO 13485 requirements, especially for smaller or starting businesses. Being a scalable and dynamic solution, this eQMS can also accompany business growth and increasing regulatory complexity.
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The cQMS is divided into 10 main modules which cover a wide range of the activities required to maintain and improve a Quality Management System for a Medical Devices company:
- Employees and Training Management
- Document Management
- Suppliers and Customers Management
- CAPA Management
- Change Management
- Complaints and Feedback Management
- NCR Management
- Audit Management
- Improvement Management
- Deviation Management
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The cQMS is configured in a way that facilitates compliance with ISO 13485, mitigates the risk of human error and increases productivity by decreasing the amount of time and effort in recurring tasks. Some key features covering these topics are:
- Permission Management
- Audit Trail
- Data Integrity
- Electronic Signature
- Traceability
- Automations and Data validation
- Mandatory Fields and Mandatory Actions
- Dashboard
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