From managing regulated documents to ensuring data integrity, Egnyte is the easiest way for emerging biotechs to get over the compliance hurdle. Effective and efficient clinical data management gets you to trial completion faster.
Achieve rapid validation without slowing down the pace of innovation.
Facilitate management of regulatory and unregulated content with a single, centralized data repository.
Increase process efficiency through automated review and approval workflows.
Comply with regulatory requirements when creating, storing, and managing GxP-regulated documents. Native support for audit trails, checksums for data integrity, and robust access control deliver a simple yet effective path to GxP and 21 CFR Part 11 compliance.
Establish a regulated environment accessible only to credentialed employees and external partners, whether your compliance envelope covers all your documents or just a single type. Use the compliance portal as a central hub to facilitate auditing, validation, and reporting.
Enable an effective document management process by facilitating collaboration, complying with regulatory requirements, and reducing the administrative burden of maintaining controlled documents.
It's been exciting to see the Egnyte product offering evolve in a way that fits extremely well with the way that biotech companies start and grow. These GXP offerings are something that early biotech companies can lean into to accelerate their launch into clinical stage operations.
We are putting all documentation submitted to FDA and other regulatory agencies in Egnyte, so that now and in the future, people know where to find the actual documentation that was given to the agencies for review.
As a small molecule R&D organization, we have work going on internally and externally. As that data comes back in from the CRO, information is automatically stored in a logical folder structure so it is organized and sent to our cloud computing platform for processing.
Egnyte for Life Sciences Streamlines GxP Compliance