Spotlight...Oracle Part 11 solution

Oracle E-Business users can look forward to a solution supporting FDA software validation requirements, including Part 11. The software giant is teaming with Arbour Group on the Validation Accelerator Pack (VAP), a framework to synchronize validation evidence based on E-Business deployment use case requirements. Arbour says in a release that the pre-configured framework outlines the validation plan and defines pre-populated validation protocols to execute with reports linked to the validation trace matrix. 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 and on-going validation. Release

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