Palo Alto, Calif. - The Copernicus Group Independent Review Board (CGIRB) is using Xerox Corporation's DocuShare CPX Enterprise Content Management (ECM) software to share and store critical biomedical research documents for the Food and Drug Administration - and expects to save more than $2 million in doing so.
CGIRB uses a secure Web-based portal with DocuShare to manage large volumes of electronic paper documents related to client studies and compliance audits. The ECM solution has saved CGIRB an estimated $160,000 annually on shipping, supplies and personnel costs, and has reduced the time to process requests from an hour to minutes. Before, CGIRB manually printed and shipped documents to multiple locations for review and filing - a timely and costly process.
"Federal guidelines require CGIRB to retain files up to 10 years, so we needed a solution that would eliminate the drain on our resources. DocuShare software has done that and helped us be more efficient and competitive," said Jennifer Sodrel, director, Information Management, CGIRB.
The review board gains further efficiency and control by using a DocuShare Compliance Module, created by Sitrof Technologies, which generates a complete audit trail of edits made to each document, including when and by whom. It also offers e-signature capabilities that comply with pharmaceutical industry regulation FDA 21 CFR Part 11, and eliminates the need for written signatures.
"Paper-intensive organizations such as CGIRB are taking control of their documents, rather than feeling overwhelmed by them," said David Smith, vice president, DocuShare Business Unit, Xerox Corporation. "With DocuShare, CGIRB has transformed its workplace - allowing them to concentrate on their core business while slashing costs, decreasing turnaround times and improving data accuracy."