BLUE BELL, Pa.--(BUSINESS WIRE)--Genocea Biosciences has partnered with Wingspan Technology to implement a validated, inspection-ready, 21-CFR-Part 11 compliant electronic system. The implementation provides one central location for internal employees, contracted partners, and potential regulatory inspectors to quickly access Genocea’s clinical documentation in a controlled environment.
Live in less than 9 weeks, the full-featured implementation of Wingspan’s eTMF included minor configuration changes to the out-of-the-box eTMF to support Genocea’s processes and their adoption of the Reference Model 3.0. Genocea’s implementation was supported by Wingspan’s Timeline Accelerators for UAT, Training, and SOPs.
“By offering a customizable eTMF system and training package, we are able to work with customers of every size to meet their specific needs, timeline, and budget,” said Troy Deck, CEO of Wingspan Technology. “Our out-of-the-box eTMF incorporates TMF Reference Model 3.0 and can be implemented in four to 10 weeks based on client-directed configuration changes. We are always happy to work with our customers to help improve and streamline their organization’s TMF process, as well as to customize the eTMF to meet their exact requirements.”
Genocea is currently migrating files from their early phase clinical projects as well as using the system for ongoing and future trials. Easy-to-use, standardized processes, supported by the Wingspan eTMF give cross-program consistency to clinical documentation, and enable Genocea to quickly assess TMF health and inspection-readiness as they continue to expand clinical operations.
About Wingspan Technology, Inc.
Wingspan Technology, Inc. is the leading provider of life sciences and eClinical software solutions, including Wingspan eTMF and DocWay, the SharePoint/Documentum integration product suite. Wingspan's talented and knowledgeable engineering and project management teams offer in-depth industry knowledge and experience to companies in life sciences, pharmaceutical, financial services, and other fields.