US Data Management Teams With Oracle to Support FDA Software Validation Requirements

REDWOOD SHORES, CA, May 19 (MARKET WIRE) --
US Data Management (USDM), a member of the Oracle(R) 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 synchronize 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 Life science 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 (GRC) 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. http://oraclepartnernetwork.oracle.com.

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. www.usdatamanagement.com

Trademarks

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Contact:

Kim Hutchings
VP, Alliances
888.231.0816x116
Email Contact

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