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).
Key Features
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Automated quarterly regression testing
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Audit Management
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Risk Management
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Traceability matrices
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Evidence-based execution records
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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.
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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.
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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.