Validation Package for Oracle e-Records

In order to ensure the proper signatures are captured for each document or event within each internal organization, part of the Electronic Record Framework enables secured users to associate the appropriate Users with each event.

An e-record contains a defined set of data from a moment in time captured by the software. This set of data is unique for each application, and each event within that application. For organizations capturing e-signatures with e-records, the intent is to present the e-record to the application user and let them approve or reject the data along with their signature. For those not using e-signatures, e-records are captured as a background process. Layouts for all OPM e-records are contained within this document and is further explored within the detail designs to follow.

E-records are captured in an XML format. XML provides portability, ultimately enabling the delivery of e-records to the FDA electronically. XML also provides longevity of the data. This helps eliminate the need to keep old versions of programs available just to read the documents. The e-records are generated using the XML data with related XSL or RTF templates.

USDM works closely with Oracle to identify upcoming patches and updates, and provides a full maintenance program for our Oracle e-Records VAP clients. Recommendations for required testing are made to ensure our clients an effective, efficient validation maintenance process.

USDM has a dedicated, experienced Siebel validation team that can customize the VAP templates and provide best practice consulting on regulatory compliance.

Equipped with over 10 years of experience and specialization in regulated business processes, our skilled team of Oracle e-Records validation professionals can provide your organization with innovative and streamlined alternatives to industry standards.
USDM has been successful across many Oracle e-Records validation projects around the globe and our best-in-class validation services coupled with proven and effective methodologies can give your organization the competitive advantage it needs to thrive in today's regulated environment.


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