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GxP Validation Made Easy

Automated Validation Service to stay compliant as Oracle Cloud gets updated quarterly

What is GxP Validation? 

GxP validation is a cloud-based, multi-tenant solution that offers automated quarterly regression testing. Shared infrastructure for all QMS customers makes validation easier by leveraging common test protocols for installation qualification (IQ), Performance Qualification (PQ) and operational qualification (OQ).

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Key Features

  • Automated quarterly regression testing

  • Audit Management

  • Risk Management

  • Traceability matrices

  • Evidence-based execution records

  • Validation reports

Key Benefits

1. Oracle provides ‘opt-in’ updates to the applications quarterly and updates the production environment when the customer approves. After an update, the customer validates only the changed items that affect their business processes.

2. Customers are notified of changes so they can assess the impact. They can perform OQ validation on the updates in their test/dev environment.  Only new application additions need revalidation, so time and overhead are minimized.

 3. Validation is made easier by leveraging common test protocols for both installation qualification (IQ), operational qualification (OQ) and performance Qualification (PQ). 

4. There are third party partners that specialize in the validating aspects. They are made aware of the upcoming changes and perform an overview validation of these deltas. 
 

5. Implementations in the Oracle Cloud environment are controlled and supported by Oracle. Oracle provides IQ data to the customer so that the customer does not have to directly perform the IQ activities. 

  • What are the three primary elements of a customer validation process?
    A predefined risk assessment determines the compliance requirements necessary to support the three primary validation deliverables listed below. Infrastructure qualification (IQ) verifies the proper installation and configuration of a system. Operational qualification (OQ) - supported by Oracle "objective evidence" documents that each SaaS release has successfully passed developmental testing. Performance qualification (PQ) is done on the basis of customer risk assessments. Quarterly testing requirements for crucial use cases are established within these parameters.
  • What methodology does Oracle follow for Cloud provisioning?
    Oracle Cloud Operations pushes quarterly updates to a customer's POD on a predetermined date. The Oracle GxP Cloud environment and update cadence have been meticulously designed to facilitate the execution of configuration and testing requirements for maintaining validation compliance.
  • What constitutes the Oracle GxP Cloud?
    Customers of the Oracle GxP Cloud will be identified, and GxP release documentation for each quarter's updates will be sent to them automatically. A minimum of three pods—development, test, and production—will be present in the GxP Cloud. The update or patch cycle for the test/production POD is independent of the development POD.
  • What value does the customer derive from adopting the Oracle GxP Validation?
    Customers can save a lot of time and money on compliance. Additionally, they get quick implementation of new product features along with effective validation of updates.

To learn more about GxP Validation, book a demo with us!

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