PRWeb The Leader Press Release Distribution
See How PRWeb Works

We're here to help 1-866-640-6397

Login Create Free Account


All Press Releases for January 31, 2002 Subscribe to this News Feed    
 

SCIMAGIX INC. TO SUPPORT REGULATORY STANDARDS FOR ELECTRONIC PHARMACEUTICAL DATA

Scimagix today announced progress toward enabling its products to comply with such standards as GxP (Good Laboratory Practice, Good Manufacturing Practice, etc.) and 21 CFR Part 11 (FDA requirements for electronic data). Now that the FDA has defined requirements for electronic data and systems as an alternative to paper submissions, the ability to audit, sign, archive and retrieve information in electronic format is critical. Scimagix's advances in this area include the addition of Dr. Janet Smith as company director of regulatory affairs to oversee initiatives for products to meet GxP and 21 CFR Part 11 standards, and new headquarters in San Mateo, Ca. featuring an automated quality assurance laboratory and a configuration management group to facilitate Smith's initiatives. Upon completion of these initiatives, Scimagix will provide the first GxP- and 21 CFR Part 11-enabled image informatics solutions.

SAN MATEO, Calif. - Jan. 28, 2002 - Scimagix Inc., the pioneer of enterprise image informatics solutions for pharmaceutical and biotechnology research and development (R&D), today announced significant progress toward developing software that is enabled to meet GxP (Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), etc.) standards as well as the U.S. Food & Drug Administration (FDA)s regulations for electronic records according to 21 CFR Part 11. Advances in this area include:

·   The addition of Dr. Janet Smith as director of regulatory affairs to oversee company-wide initiatives and commitments for Scimagixs products to meet GxP and 21 CFR Part 11 standards.

·   Scimagixs new headquarters at 2855 Campus Drive in San Mateo, featuring an automated quality assurance laboratory and a configuration management group to facilitate initiatives led by Smith. The move was precipitated by the company doubling its number of customers, tripling its revenue and increasing its staff.

Scimagixs GxP and 21 CFR Part 11 initiatives represent the companys commitment to providing an R&D infrastructure that allows pharmaceutical companies to meet the highest standards of data security and integrity while maintaining the flexibility to solve day-to-day, image-based problems. Upon completion of these initiatives, Scimagix will provide the first GxP- and 21 CFR Part 11-enabled image informatics solutions.

Under 21 CFR Part 11, the FDA defines requirements for electronic data and systems as an alternative to paper submissions, making the ability to audit, sign, archive and retrieve information in electronic format critical. Using Scimagixs Scientific Image Management System (SIMS) platform, scientists can archive both new and legacy image electronic data in a searchable, Web-based, Oracle® database that dramatically improves the capability of their company to utilize image information to better interpret experiments, gain insights and make better decisions.

Smith brings to Scimagix nearly 15 years of experience in software development and support, including management of quality assurance and database development. Prior to Scimagix, Smith was vice president of database and development operations at MDL Information Systems and was responsible for the QA of software systems provided by P. E. Nelson. She holds a Ph.D. in analytical chemistry from the University of Michigan.

We are delighted to welcome Janet to Scimagix at such an exciting time, both for the company and for image informatics," said Robert Dunkle, president and CEO, Scimagix. Upon completion of our initial GLP and 21 CFR Part 11 initiative, SIMS will be the industrys first and only image informatics solution satisfying these critical requirements, and were thrilled to have a seasoned professional such as Janet heading up that effort."

I look forward to contributing as part of the Scimagix team, working closely with our customers, partners and regulatory agencies to keep Scimagix on the cutting edge of GxP and 21 CFR Part 11 standards," said Smith. This capability enables our customers to move data among research, preclinical and clinical applications while simultaneously conforming to the standard operating procedures of each of those operations, to maximize the value of applying related data to understanding biological processes and to improve decision making."

About Scimagix Inc.
Scimagix Inc., based in San Mateo, Calif., is the leading provider of image informatics solutions for pharmaceutical research and development (R&D). Its flagship SIMS (Scientific Image Management System) platform is the first database management system designed to optimize the use of images generated during drug R&D. The Oracle®/Web-based software system is an open architecture platform that enables group- to enterprise-wide image management, providing researchers with a comprehensive and searchable database of image data. The Scimagix Application Suite supports high throughput analysis and mining of image data with its proprietary visual content search technology. This innovative technology dramatically increases the accuracy and productivity of R&D processes by enabling users to select and search based on a specific region of an image, to easily retrieve image sets from diverse experiments based on specific search parameters, to identify correlations, and to gain access to expert data across laboratories and the corporation. Scimagix presently serves eight of the top 15 pharmaceutical companies, including Pfizer Global R&D and Eli Lilly & Co.

Scimagix is located at 2855 Campus Drive, Suite 100, San Mateo, CA 94403. For additional information, please visit Scimagixs corporate Web site at www.scimagix.com or call 650/377-2300.

OPTIONS
Printer Friendly Version
Email this story to a colleague
CONTACT INFORMATION
Jenny Hunter
Magnet Communications
510-450-2618
Email us Here
ATTACHED FILES

There are no multimedia files attached to this release. If this is your release, you may add images or other multimedia files through your PRWeb News Management Console.

ABOUT PRESS RELEASES
If you have any questions regarding information in these press releases please contact the company listed in the press release. Please do not contact PRWeb. We will be unable to assist you with your inquiry. PRWeb disclaims any content contained in these release. Our complete disclaimer appears here.