Navigation Links
RadPharm Finds Cure to Efficiently Manage Regulated Documents with EMC
Date:1/28/2009

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.

About EMC

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

Related medicine news :

1. RadPharm Announces $10 million Series B Financing, led by Siemens Venture Capital
2. Frost & Sullivan Finds Compliance Requirements Drive the Healthcare Security Boom
3. St. Jude finds more than 100 gene variations linked with response to leukemia treatment
4. Verified Physicians a Must for Ensuring Quality Data From Online Surveys, Finds Frost & Sullivan
5. Manhattan Research Survey Finds That Physicians Overwhelmingly Support Commercially-Funded Continuing Medical Education
6. Study Finds High-Fructose Corn Syrup Contains Mercury
7. Cell phones dangerous for child pedestrians, UAB study finds
8. Children with inflammatory bowel disease have surprisingly high folate levels, study finds
9. Children with Inflammatory Bowel Disease Have Surprisingly High Folate Levels, Study Finds
10. U.S. Government Finds 40% of People Currently Receiving Long Term Care are 18-64; Numbers Continue to Rise
11. UCSF Finds Potential New Antibody Treatment for Autoimmune Diseases
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/8/2016)... ... February 08, 2016 , ... Guruji Mahendra Kumar Trivedi is ... 11th, 2016 in honor of his birthday on February 10th. During this time, ... Trivedi is known by over 250,000 people from over 40 different countries as an ...
(Date:2/8/2016)... ... February 08, 2016 , ... According to research by the ... dental technicians to be certified or obtain continuing education. To increase patient awareness ... In Your Mouth?” campaign to inform dentists and patients about the possible lack ...
(Date:2/7/2016)... Birmingham, Lake Orion, Clarkston, Metamora, Michigan (PRWEB) , ... February 07, ... ... women on Friday in recognition of National Wear Red Day. National Wear Red ... heart disease and stroke in women. Heart disease and stroke cause 1 in 3 ...
(Date:2/7/2016)... ... 2016 , ... Dr. Todd Hobgood , certificated in ... surgical expertise. Technically known as deoxycholic acid or previously as ATX-101, Kybella® ... for reduction of fat below the chin (aka the “double chin”). Medication side ...
(Date:2/6/2016)... ... 2016 , ... US Sports Camps is proud to sponsor the Bay Area ... top non-profit leaders, ultimate organizations, and coaches from around the US. The theme for ... Program Director of Youth and Education, describes this year YUCC as “an important conversation ...
Breaking Medicine News(10 mins):
(Date:2/8/2016)... , Feb. 8, 2016 ... the addition of the "Label-Free Detection ... Forecasts to 2020" report to their ... announced the addition of the "Label-Free ... Global Forecasts to 2020" report to ...
(Date:2/8/2016)... , Feb. 8, 2016  Unilife Corporation ("Unilife" or "Company") ... of injectable drug delivery systems, today announced that it will ... ended December 31, 2015 after market close on February 9, ... conference call to discuss these financial results.    ... --> About Unilife Corporation ...
(Date:2/8/2016)... 8, 2016  Sangamo BioSciences, Inc. (NASDAQ: ... announced that the U.S. Food and Drug Administration ... (IND) application for SB-318, a single treatment strategy ... Type I (MPS I). The SB-318 IND application ... a Phase 1/2 clinical study (SB-318-1502) designed to ...
Breaking Medicine Technology: