Automates Paper-Based Processes to Collaborate and Achieve Compliance
HOPKINTON, Mass., Jan. 28 /PRNewswire/ -- EMC Corporation (NYSE: EMC), the world leader in information infrastructure solutions, today announced that RadPharm is using EMC's Documentum(R) Compliance Manager (DCM) to centrally store, review, approve and manage revisions to regulated documents such as standard operating procedures (SOPs). As a result, RadPharm has gained improved efficiencies in meeting compliance requirements.
RadPharm, a leading imaging core laboratory (ICL), partners with pharmaceutical, biotechnology and medical device companies to provide management and analysis of medical images for clinical trials. Medical imaging plays a crucial role in the conduct of clinical trials and can assist in speeding vital new drug and medical device products to market. RadPharm's expertise has been honed over 15 years, on over 330 studies -- Phase I through IV -- across 60 countries and spanning all major modalities and therapeutic areas. In addition to having supported more oncology trials than any other ICL, RadPharm also possesses experience with cardiovascular, musculoskeletal, CNS, diagnostic contrast imaging agents and medical device studies.
"When potential customers ask us what system we use for document control, we say Documentum Compliance Manager," said Harvey Guindi, Director of Information Systems at RadPharm. "To our customers and regulators, it shows that we use the industry-leading content management system to be in strict regulatory compliance and we have the audit trails to prove it."
With DCM, RadPharm has automated the processes involved in creating and updating their SOPs, routing them for approval and ensuring that employees are accessing the most current versions. DCM is integrated with RadPharm's learning management system to achieve compliance related to employee training. Employees are required to read SOPs within 90 days of their employment start date and within 20 days of when an SOP has been approved.
"DCM has streamlined our employee training process," said Guindi. "Before, employees had to track down binders that contain paper-based SOPs. We also used paper to keep track of which employee read which SOP. With an average of 40 SOPs per employee, it meant manually reviewing 20 forms to ensure compliance for a single employee. Multiply hundreds of employees and between 90 to 100 SOPs, the process was very time-consuming."
The transition to electronic-based SOPs also allows RadPharm to better collaborate without losing document control. Radiologists, physicians, oncologists and other employees who are part of clinical project teams have the ability to share and route information and keep track of its state -- who has reviewed and approved the document. This provides RadPharm with an audit trail system to meet regulatory filing requirements.
About EMC Documentum Compliance Manager
EMC Documentum Compliance Manager (DCM) provides an audited environment where users can create, collaborate, review, revise, approve and distribute controlled or regulated content. As a result, it can be used to help customers achieve compliance with external regulations such as 21 CFR Part 11 and internal policies while maintaining high product and service quality standards. DCM 6.5 now provides e-signatures, watermarking and overlays as native Web services to simplify installation and deployment. It also offers XML document support to manage controlled content authored in XML.
EMC Corporation (NYSE: EMC) is the world's leading developer and provider of information infrastructure technology and solutions that enable organizations of all sizes to transform the way they compete and create value from their information. Information about EMC's products and services can be found at www.EMC.com.
EMC and Documentum are registered trademarks of EMC Corporation and its subsidiaries. All other trademarks are property of their respective owners.
|SOURCE EMC Corporation|
Copyright©2009 PR Newswire.
All rights reserved