CARA, Generis’ innovative and leading user interface for Documentum now assists Medical Device Companies in meeting FDA and other regulatory and quality requirements for the design, development and manufacture of Medical Devices, based on the DIA’s Reference Model.
Regulators require that all providers, manufacturers and distributors of Medical Devices meet a stringent approval process and abide by rigorous quality standards before and after a Device is distributed. In addition, all associated records in this process must be securely maintained.
CARA, Generis’ fast, friendly and flexible user interface for Documentum is now able to help organizations meet this challenging task. CARA manages Design History Files (DHF), Device Master Records (DMR) and Device History Records (DHR), as well as the individual source documents required for Medical Devices. CARA also shortens the implementation time of a compliant document management system to support Medical Device submissions and post-approval maintenance, thanks to its fully featured customization and workflow-driven technology.
Our pre-configured Medical Devices package drives down the overall cost and timeframe of an implementation while retaining the configurability and customisation which CARA is industry recognised for. We understand that each use case provides a unique challenge and our approach to configuration, and our iterative fountain approach to development allows for user feedback to drive the end delivery of the product.
The DHF, DMR and DHR are maintained in CARA’s dynamic repository where documents and other information can be compiled and accessed ready for either submission or for adhering to regulations such as the FDA 21CFR 820 (design and document controls). However, CARA not only serves as a central hub for these files for documenting, developing and approving purposes, but also accelerates a Device’s development process thanks to CARA’s workflow capabilities.
Virtual documents in CARA can be configured to automatically populate with pre-set documents which are required for either submission or documentation. These documents can also automatically trigger the creation of workflows which can then be allocated out by a submission administrator. The automatic population of DHF, DMR and DHR templates with placeholder documents rapidly provides users the foundations from which to build a submission, while workflows effectively divide tasks for easy completion.
James Kelleher, Generis CEO, commented “Our focus is centred on developing CARA to best respond to the challenges raised by growing compliance, regulatory and quality requirements faced by Life Science organizations. Helping those involved in the product development and production life cycle of Medical Devices can only result in an even more compelling proposition to those who wish to access and manage all information through a single user interface.”
To find out more, please view the recording under the Recorded Webinars tab.