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 QUMAS Quality Management Solution for Global Regulatory Compliance covering:
- SOP Management – Document creation, editing, review and approval in conjunction with 21 CFR Part 11 compliance
- Training Management – full learning management capabilities, read and understood, multiple choice examination, and electronic signature
- Overview of CAPA, Deviation, Change Control, Audit, Complaints, others
- Reporting and dashboards – getting the metric/analytics from the system in a timely manner