Managing Regulated Content in WebCenter: USDM and Oracle Offer a New Part 11 Compliant Solution for Life Sciences

Posted by Michael Snow on Oracle Blogs See other posts from Oracle Blogs or by Michael Snow
Published on Tue, 26 Jun 2012 19:00:00 +0000 Indexed on 2012/06/26 21:22 UTC
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Guest post today provided by Oracle partner, USDM 

Regulated Content in WebCenter
USDM and Oracle offer a new Part 11 compliant solution for Life Sciences
 (White Paper)



Life science customers now have the ability to take advantage of all of the benefits of Oracle’s WebCenter Content, a global leader in Enterprise Content Management.   For the past year, USDM has been developing best practice compliance solutions to meet regulated content management requirements for 21 CFR Part 11 in WebCenter Content. USDM has been an expert in ECM for life sciences since 1999 and in 2011, certified that WebCenter was a 21CFR Part 11 compliant content management platform (White Paper).  In addition, USDM has built Validation Accelerators Packs for WebCenter to enable life science organizations to quickly and cost effectively validate this world class solution.

With the Part 11 certification, Oracle’s WebCenter now provides regulated life science organizations  the ability to manage REGULATORY content in WebCenter, as well as the ability to take advantage of ALL of the additional functionality of WebCenter, including  a complete, open, and integrated portfolio of portal, web experience management, content management and social networking technology.  Here are a few screen shot examples of Part 11 functionality included in the product: E-Sign, E-Sign Rendor, Meta Data History, Audit Trail Report, and Access Reporting.


Access Reporting
Audit Trail Report

E-Signature

E-Signature

Metadata history


Gone are the days that life science companies have to spend millions of dollars a year to implement, maintain, and validate ECM systems that no longer meet the ever changing business and regulatory requirements.  Life science companies now have the ability to use WebCenter Content, an ECM system with a substantially lower cost of ownership and unsurpassed functionality.

Oracle has been #1 in life sciences because of their ability to develop cost effective, easy-to-use, scalable solutions which help increase insight and efficiency to drive growth for their customers.  Adding a world class ECM solution to this product portfolio allows life science organizations the chance to get rid of costly ECM systems that no longer meet their needs and use WebCenter, part of the Oracle Fusion Technology stack, with their other leading enterprise applications.

USDM provides:

•    Expertise in Life Science ECM Business Processes
•    Prebuilt Life Science Configuration in WebCenter
•    Validation Accelerator Packs for WebCenter

USDM is very proud to support Oracle’s expanding commitment to Life Sciences….

For more information please contact:  [email protected]


Oracle will be exhibiting at DIA 2012 in Philadelphia on June 25-27. Stop by our booth (#2825) to learn more about the advantages of a centralized ECM strategy and see the Oracle WebCenter Content solution, our 21 CFR Part 11 compliant content management platform.

DIA 2012



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