Get 21 CFR Part 11 compliance done the modern way.
Rave RCM (Regulated Content Management) is the first end-to-end content and data collaboration platform that actively maintains inspection readiness. Unified within the Medidata Rave Clinical Cloud, RCM bundles Rave eTMF, Rave SOP Management, and Rave Archive, so you can create, store, approve, and work on regulated content in a single application with an intuitive, powerful user interface.
One platform for storing and managing all your content. Rave RCM is a single repository for all content created and managed within the application on the Rave Platform.
Simplifies the filing and oversight of TMFs and ensures TMF completeness and compliance through artifact pre-population, role-based workflows, and intuitive reporting and dashboards.
Rave EOS (End of Study)
The first end-to-end solution that seamlessly generates, distributes & manages study files at the end of a study. With Rave EOS, sites’ study files are accessible and downloadable by a secure and trusted unified platform, eliminating the need to create and distribute physical media and deal with manual acknowledgment forms.
A cloud-based digital preservation repository that maintains your organization’s information, keeping content accessible, searchable and usable regardless of where the content originated. Archive provides long-term content integrity and authenticity in a secure and compliant environment.
See how Zosano Pharma benefited from using Medidata Rave RCM solution to author, review and approve their documents quickly and on-the-go