With our CFR 21 Part 11 validation, we can now provide a cohesive document management solution for a secure, compliant and easy to use portal for clinical and preclinical documents generated during the study process.
Atlanta, GA (PRWEB) May 31, 2011
V-Rooms Virtual Data Rooms has completed accreditation of their software solution in compliance with “FDA Code of Federal Regulations 21 Part 11 – Electronic Records; Electronic Signatures” which defines the requirements for the creation, transmission and retrieval of electronic documents associated with pre-clinical and clinical trials.
"The medical product development process for turning new laboratory discoveries into treatments or products that are safe and effective is no longer able to keep pace with basic science innovation," said Karen Perkins, President of V-Rooms. "Today’s translational research and clinical trial facilities are swimming in information and drowning in documents. Critical changes are needed to improve this development process by establishing and using new technological tools for document and data sharing, organization and management."
“Our V-Rooms have been assisting life science companies, including medical device, biotech and pharmaceutical firms, in their fundraising and strategic partnering efforts for years,” said Dan Bradbary, CEO of V-Rooms. “With our CFR 21 Part 11 validation, we can now provide a cohesive document management solution for a secure, compliant and easy to use portal for clinical and preclinical documents generated during the study process.”
V-Rooms Virtual Data Rooms fulfills a critical need for a central documents repository, rather than relying on email, fax or courier of documents. Data Rooms fill this need for a technological tool that allows facility staff members and key sponsor personnel to access all of a site’s documents residing in a central, real-time accessible location. Different levels of user access determine what information is available to each user, complete with automated audit trails detailing document usage.
The solution enables study directors, sponsors and facility team members to manage, organize and retrieve the massive number of documents that are used by all members of the team during the study and then provides a platform for the assimilation of final study findings. Reports that are generated and returned to a study sponsor would shorten the amount of time needed for the clinical trial process, which translates into thousands and in some cases, millions of dollars in cost savings.