With a large volume of electronic documents to manage, and the criticality in nature of these documents, Medical Device companies must have a robust, easy to use, 21 CFR Part 11-compliant Document Management Solution. The QUMAS DMS will support the organization across multiple business areas, including areas with specific requirements such as quality, research and development, and regulatory. The solution should allow easy yet secure access, with the ability for authorized users to collaborate, review, and approve documents via configurable workflows, and also provide fast and easy search and retrieval capabilities to quickly locate documents. In addition to providing secure and controlled access to various types of documents, the solution needs to provide strict version control and the ability to have special controls set over electronic document distribution and hardcopy printing, with overlays printed on the documents such as document status, printed by, and date timestamps.
For more information, download this webinar on Manage your Quality and Compliance Needs with an Integrated Electronic Document Management System covering:
•Single point of web-based access to all compliance content and functionality
•Electronic Document Management
•Integrated CAPA Management
•Dashboarding and Reporting
•Full support for 21 CFR Part 11 Electronic Signatures, with full Meaning of Signature based on user role