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Oracle Recenter Content 21 CFR Part 11 Certification Kim Hutchins US Data Management Phone: 888-231-0816 Email: Hutchins usdatamanagement.com Oracle Recenter Content Part 11 Certification Introduction
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The test is being performed under contract between USDA and Oracle. The purpose of the test is to ensure that all of Oracle's Recenter Content ECC platform software provides ECC validation, that it meets applicable specification specifications, and that it is capable of complying with the specification for the US Food and Drug Administration regulations. The test will focus primarily on the ECC validation tool developed for the Oracle ECC platform, the ECC Validation Checker (ECC-VC) and verification framework contained in the ECC-VC. The purpose of this report is to describe the test's objectives and design of the test instrument, test results from the test, a summary of the test's findings, and the test's results in general terms and specific results. This report should be read with the full Terms of Service, and the complete Terms of Use for the ECC Validation Checker, which can be found at the following URL. The full Terms of Use and a copy of the ECC Validation Checker, as well as the Test and Results Report referenced in this report, can be found on the CV site at ECC Validation Checker Test Results (Tests, Results, Analysis). Note: The Oracle Recenter Content 11g platform was not specifically targeted for the test and has not been designed to be compliant with the US Food and Drug Administration regulations. As such, the test and results were not subject to specific test conditions. The test was conducted at the Oracle Performance Testing Center in Scottsdale, Arizona. The test environment was Oracle's in-house development computer lab, consisting of a single computer that is the test platform. Testing was conducted in accordance with all applicable laws and regulations, and in compliance with applicable certification guidelines and standards. The test report describes the testing process for the test and describes the results and findings of the analysis for the test and the test results for the test instruments and test results report. This test was conducted over a 12-month testing period from May 2011 to February 2012. The test environment included the following components. A full stack EC2 instance: A single EC2 instance configured to run Oracle Recenter Content 11g for the test suite. A complete set of software and applications installed on the test instance, including: O/S: Oracle Data Warehouse 11g, Oracle Recenter Content 11g Platform Suite (PCS), Recently CMS 7.7.

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