USDM Works Closely With Oracle To Harmonize Compliance
Providing pre-populated templates to support FDA validation requirements for Oracle applications including Agile, JD Edwards EnterpriseOne & Siebel CRM
Redwood Shores, CA May 19, 2009 - US Data Management (USDM), a member of the Oracle® PartnerNetwork, announced that it is teaming with Oracle to provide a comprehensive solution to support FDA Part 11 software validation requirements for Oracle applications.
USDM Validation Accelerator Packs (VAP) for Oracle’s JD Edwards and Oracle’s Siebel CRM are based on 6 years of experience supporting VAPs for Oracle’s Agile Product Lifecycle Management application. The VAPs provide a complete framework to syncronize validation evidence based on specific deployment use case requirements.
The VAP’s pre-configured framework outlines the validation plan and defines pre-populated validation protocols to execute with reports linked to the validation trace matrix which assures validation integrity. Execution of the validation process and VAP documents can also be managed in Oracle Governance, Risk and Compliance Manager to support enterprise validation best practices to assure on-going maintenance of multiple Oracle application(s) validation.
“The Oracle Lifescience customer base continues to emphasize the high cost associated with FDA (part 11) software validation requirements, the VAPs provide a significant opportunity for our Life Science customers to reduce the cost and deployment time associated with this critical business requirement of the FDA.” States Todd Hein Senior Director, Oracle Life Science Business Unit.
“This standard VAP format for multiple Oracle applications combined with the Oracle Governance, Risk and Compliance Manager provides an enterprise solution for achieving validation and maintaining a validated state across the enterprise IT platform. This combination enables validation best practices which help assure validation integrity and significant reduction in validation cost,” says Kim Hutchings, VP of Alliances, US Data Management.
About the Oracle PartnerNetwork
Oracle PartnerNetwork is a global business network of more than 20,000 companies who deliver innovative software solutions based on Oracle software. Through access to Oracle’s premier products, education, technical services, marketing and sales support, the Oracle PartnerNetwork program provides partners with the resources they need to be successful in today’s global economy. Oracle partners are able to offer their customers leading-edge solutions backed by Oracle’s position as the world's largest enterprise software company. Partners who are able to demonstrate superior product knowledge, technical expertise and a commitment to doing business with Oracle qualify for the Certified Partner levels.
About US Data Management
US Data Management (USDM) is a leading global regulatory consulting firm providing compliance, validation, qualification, quality, auditing and information technology services to our clients in the Medical Device, Biotechnology, Biologics, Diagnostics and Pharmaceutical industries. USDM has more than 10 years of experience supplying our clients in the life science industry with compliance services during each phase of their drug and product development cycle. USDM partners with best of breed organizations like Oracle to help companies simplify, unify and optimize their business and compliance objectives.
Contact:
Kim Hutchings
VP, Alliances
888.231.0816x116
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