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:8/18/2017)... York, New York (PRWEB) , ... ... ... International Courier, LLC, d/b/a Quick International, LLC (“Quick”), a highly specialized asset-light ... announced it has entered into a definitive agreement to purchase Unitrans International ...
(Date:8/18/2017)... ... August 18, 2017 , ... As an industry ... educational webinar, they will present the line of epMotion automated liquid handling system. ... you can automate everyday pipetting tasks. , Ideal for scientists and lab technicians ...
(Date:8/18/2017)... ... August 18, 2017 , ... Moore Insurance, a Houston area ... Texas, is launching a regional charity effort to provide publicity assistance and generate ... Brain Tumor Foundation (PBTF) has raised nearly $30 million in donations that has ...
(Date:8/18/2017)... Bedford, TX (PRWEB) , ... August 18, 2017 , ... ... serves communities in the Dallas/Fort Worth area, is spearheading a regional charity campaign organized ... her husband. , In early June of this year, Christina and her children returned ...
(Date:8/18/2017)... Boca Raton (PRWEB) , ... August 18, 2017 , ... ... is continuing to ramp up its marketing efforts with its product now available through ... hangover remedy to the public. The effervescent powdered drink is designed to quickly detox ...
Breaking Medicine News(10 mins):
(Date:8/14/2017)... N.J. and PETACH TIKVAH, Israel ... Inc. (NASDAQ: BCLI), a leading developer of adult stem ... the second quarter ending June 30, 2017. ... stages of preparing for our pivotal Phase 3 trial ... Chaim Lebovits , President and Chief Executive Officer of ...
(Date:8/8/2017)... 2017  BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical ... financial results for the second quarter ended June 30, ... quarter 2017 and to date: ... for the Company,s lead project, BL-8040: ... BL-8040 as novel stem cell mobilization treatment for autologous ...
(Date:8/7/2017)... , Aug. 7, 2017 Zimmer Biomet Holdings, ... healthcare, today announced that its Board of Directors has approved ... the third quarter of 2017. ... paid on or about October 27, 2017 to stockholders of ... 2017.  Future declarations of dividends are subject to approval of ...
Breaking Medicine Technology: