PRINCETON (PRWEB) November 30, 2005
Innovative Programming Associates (“IPA), a global provider of “best in class” pre-clinical software solutions for the Life Sciences industry, today announced that it has formed a strategic partnership with US Data Management (“USDM”), a leading provider of IT, validation, and regulatory compliance solutions for the life sciences industry. This partnership was finalized in June of this year and together IPA and USDM offer its customers a best practices approach to the validation of IPA’s LABCAT pre-clinical software suite.
Regulated by the Food and Drug Administration (FDA), bio/pharmaceutical, medical device manufacturing organizations and tissue processors must ensure the computer systems they use to create, modify, maintain, archive or transmit critical data, operate as intended and meet FDA requirements. For these companies, computer system validation is key to ensuring their systems meet overall business objectives and comply with industry regulations.
Together, IPA and USDM have many successful customers who have put into practice this tailored, easy-to-implement solution that addresses the validation needs of both new system implementations and customer upgrades, accelerating the validation cycle by more than 25 percent. Through this partnership IPA customers will have access to a complete solution from a single provider that has intimate knowledge of both the life sciences industry and the LABCAT product suite.
“IPA is an ideal partner, with a strong presence in the life sciences industry and a large network of customers,” said Erik Smith, Vice President of Business Development for USDM. “Our in-depth industry and application knowledge-base and regulatory compliance insight, paired with IPA’s world-class LABCAT software suite focused on the life sciences industry, produces an offering unique to the industry. This end-to-end solution for enterprise processes with system validation compliance provides customers with a complete package from one provider at a fraction of the cost.”
USDM uses proven and recognized methodologies for computerized system validation, helping organizations ensure that the systems they use are monitored, controlled and capable of performing their intended functions in a reliable and reproducible manner. Designed specifically to fit with the LABCAT software suite, USDM’s validation process enables companies to protect and maintain the integrity of the data, providing documented evidence of quality performance.
“At IPA we strive to work with our customers to share best practices and find solutions that reduce the significant costs of regulatory compliance,” said Kathleen Updike, Vice President of Business Development for IPA. “We feel it is incumbent on IPA, as a good business partner, to take a major share of the compliance responsibility. We do so by providing our customers with the proven validation workflow, plans, standard procedures, test scripts and traceability matrix paired with the deep validation expertise of USDM. As a result of the knowledge built during many validation projects we can provide a solution to reduce risk, cost and time to validate for all IPA customers.”
About US Data Management
US Data Management provides state-of-the-art computer system compliance solutions to FDA regulated pharmaceutical, biotech, medical device companies and contract research/manufacturing organizations. The company’s goal is to assure that FDA regulated computer systems are operating in a compliant environment in accordance with a company's overall strategic objectives. For more information, visit http://www.usdatamanagement.com.
IPA develops and markets a complete suite of non-clinical data collection and reporting software products used worldwide for the pre-clinical phase of product development for the pharmaceutical, biopharmaceutical and biotechnology industries. For more information, visit http://www.labcat.com.