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Use Oracle BI Agents to detect specific analytic results and notify appropriate user or group about the result.Use Oracle BI Publisher to create formatted and printable reports.The primary regulatory requirements include: (i) data tracking and (ii) Extract Transform Load (ETL) Version Management.The origin of any data displayed in a report must be traceable to its source, and all transformations applied to the data must be accessible.

Access to execute ETL routines is restricted to a specific privilege, which can be granted to a user group or role.This single platform provides secure access to authorized users.It provides reduced total cost of ownership through reduced data integration costs and infrastructure maintenance costs, compared with multiple warehousing solutions.Oracle Pharmacovigilance Operational Analytics (OPVA) is an analytical and transactional reporting application based on a predefined set of key performance indicators (KPIs), facts, and dimensions with support for predefined and custom reporting.OPVA also functions as a decision support system to monitor process bottlenecks and compliance deviations.

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Data sourced from Oracle Argus Safety is traced by the following criteria and rules: Execution of the ETLs is controlled by Oracle Data warehouse Administration Console (DAC).

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