Medical Device content and submissions management
CARA provides an accurate and secure repository for maintaining DHF, DMR & DHR, serving as a central hub for documentation, development and approval. CARA’s workflow capabilities accelerate development, shortening the implementation time to support Medical Device submissions and post-approval maintenance.
CARA for Medical Devices
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, the fast, friendly and flexible user interface for Documentum, Alfresco and Oracle WebCenter is now able to help organizations meet this challenge.
Create or import files, records and other information directly in CARA, ready for submissions and adhering to regulations (e.g. 21CFR 820). Co-author and review selected documents within CARA’s secure collaborative environment. Approve documents with CARA’s electronic signature capabilities or through integrations with DocuSign and Adobe Sign.
Generis can configure Structures to meet with company-specific requirements. E.g. automatically populate DHF, DMR and DHR templates with placeholder documents required. Set up workflows to manage and trace every step of the design phase and production process and divide tasks for fast, easy completion.
Submitting documents once the file has been compiled and approved for submission is easy in CARA. The documents within a Virtual Document can be transferred in a variety of formats, including to a ZIP File or concatenated to either Word or PDF. We have a range of integrations with publishing tools in order to streamline submissions, including planning.
CARA can empower easy collaboration with third parties. The dynamic per-document-per-workflow security means that access can be granted to the repository and only users with workflows can see any documents. This includes being able to have collaborative (simultaneous authoring) using technology such as SharePoint or Google Docs.
Track & re-use
With the use of CARA Structures, re-using components or entire sections of submissions multiple times becomes easy, allowing dossiers to be assembled for different regions more quickly, while also allowing tracking of the submission status and where individual components have been used, thus allowing easier updates to multiple regions.