Amadeus Partners with US Data Management
Quebec City (Quebec), October 25th, 2004 - Amadeus Inc., worldwide leader in developing and marketing flexible compliance process automation software solutions, today announced that they have partnered with US Data Management (USDM), a leading provider of IT and regulatory compliance solutions for the Life Science industry.
Due to ever-changing regulations, shareholder pressures to increase productivity and the desire to shorten time to market expectations, organizations in the Life Science sector are trying to automate and streamline their quality management systems. To ensure that the market-available software solutions will properly deliver what they promised, highly regulated Life Science companies turn to US Data Management to assist with the validation of various FDA compliant software solutions of leading providers. “Computer System Validation and 21 CFR Part 11 compliance continue to be important issues facing FDA-regulated companies. The partnership between US Data Management and Amadeus will enable our mutual customers to implement a proven eQCM® solution with the certainty that it operates as intended and meets current FDA requirements.” said Mr. Erik P. Smith, VP - Business Development of US Data Management.
“One of the major distinctive aspects about eQCM® is that Amadeus empowers their clients to configure their compliance processes themselves, without affecting the physical code of the application, rather than having to ask the vendor to modify its software. This gives tremendous flexibility and independence to the client”, added Mr. Smith.
Few vertical markets face the regulatory requirements that are part of the everyday challenges in the Life Science industry. The fact that compliance becomes a moving target based upon technological advances and the numerous regulations, organizations are looking for flexible solutions that can be configured out-of-the-box, validated and deployed from a global perspective. “The FDA regulated companies not only need to ensure that the application will operate efficiently, they have to document the requirements and test the application’s ability to meet those requirements. After selecting an application that best fits the documented requirements, the next challenge is identifying a service organization with the experience to assist in the validation and implementation of the solution. Acknowledging this necessity, Amadeus is proud to partner with industry expert US Data Management. Their experience will guarantee that the company's overall strategic objectives are met.” revealed Daniel Bordeleau, VP - Strategic Alliance of Amadeus.
Since opening its New Jersey office in April and its partnership with USDM, headquartered in California, Amadeus is now in a more strategic position to exceed the expectations of US pharmaceutical, biotech, and medical device companies from the East to the West Coast.
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About US Data Management
US Data Management (USDM) is a leading provider of IT and regulatory compliance solutions for the life science industry.
USDM provides state-of-the-art computer system compliance services to FDA regulated pharmaceutical, biotech, medical device companies and contract research organizations. USDM'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.
Some of USDM's services include — System Compliance Assessments, 21 CFR Part 11 Assessments, Remediation and Training, Vendor Audits, SOP Development, Computer System Validation (CSV), CSV Training and Education and Long-Term Compliance Staffing.
About Amadeus
Amadeus is a pioneer and leader in compliance process control solutions. Its flagship product, eQCM®, is a flexible, Web-based integrated suite of applications that allow organizations to map regulated business processes such as CAPA, non-conformances, customer complaints, audits, and other related quality and business processes. The application suite is coupled with powerful business intelligence capabilities, enterprise content management, and related technologies that help organizations achieve sustained compliance. Amadeus's global headquarters are located in Quebec City. Amadeus solutions are distributed across four continents.
Information
US Data Management
Erik P. Smith, VP - Business Development
1746-F S. Victoria Avenue, PMB 388
Ventura, CA 93003-6538, USA
Phone: (805) 899-8144, ext. 154
E-mail: esmith@usdatamanagement.com
Amadeus Inc.
400 Jean-Lesage Boulevard, Suite 500
Quebec City , QC , G1K 8W1 , Canada
Isabelle Rivoal
Communications Manager
Phone: (418) 525-0606 ext. 2231
