Egnyte Launches eTMF Quality Control Feature
New Features Allow Customers to Leverage the eTMF Solution Throughout the Review Process in a GxP-Compliant Environment
Mountain View, CA. – November 28, 2023
Egnyte announced today a new Quality Control feature for its electronic Trial Master File (eTMF) application. This feature allows users to conduct review and approval workflows on documents in the eTMF application before formally filing sensitive trial content into their TMF, removing the complexities associated with operating across multiple systems.
“Egnyte’s new eTMF Quality Control feature joins a suite of eTMF-focused features in the Egnyte platform and is a reflection of our commitment to creating industry-leading solutions that improve workflows and data management for biotechs,” said Abhay Kini, director of Life Sciences at Egnyte. “Integrating the review process into the eTMF solution not only improves the user experience, it also enables companies to better adhere to regulatory guidelines.”
With Egnyte’s eTMF platform, customers can consolidate clinical trial data on their own infrastructure, leverage actionable insights, and maintain compliance on Egnyte’s GxP-compliant platform. All parties, including external document contributors, can import documents directly into an inspection-ready platform securely and fully audited, eliminating the need for multiple systems and safeguarding the company’s data.
“Our CRO partners were easily trained to use Egnyte’s eTMF, and our study documents can now be seamlessly filed in the platform. One of the key benefits of this process is that we have direct access to all of our documents right when they’re loaded,” said Heather Wolff, vice president of Development Operations at Sionna Therapeutics.
Earlier this year, Egnyte launched eTMF import and archival capabilities, including the ability to utilize the eTMF-EMS as an importing mechanism, establishing a simple three-step import process with no limit on the size of the TMF to import, and the ability to capture all importing events in audit reporting.
Egnyte’s user-friendly archival capabilities enable users to set retention periods, archive data and documents, and protect archived content from unauthorized access, ensuring compliance with minimal manual effort in a unified platform at no additional cost.
To learn more about Egnyte’s latest eTMF Quality Control feature and other upcoming platform enhancements, register for Egnyte’s virtual Global Summit on December 6, 2023.