1 About Oracle Safety One Intake

Oracle Safety One Intake is an advanced pharmacovigilance system that optimizes the handling of Adverse Event (AE) documents.

Oracle Safety One Intake works seamlessly with Oracle Argus Safety 8.4.1 and provides multiple options for ingesting AE documents, such as automatic uploads via API or email, or manually. These AE documents are then processed in an automated workflow, which can involve manual steps too.

Oracle Safety One Intake processes AE documents into cases, in a sequential workflow. The workflow is as follows:

1. A user uploads an AE document to Oracle Safety One Intake.
2. Oracle Safety One Intake checks the document. Depending on a predefined configuration, the document may require optional manual validation and grouping.
3. Oracle Safety One Intake classifies the document.
4. To extract adverse event data from the document, Oracle Safety One Intake utilizes Optical Character Recognition (OCR) and Machine Learning (ML). As part of this step, Oracle Safety One Intake marks records that require manual review, which can involve reviewing and confirming extracted information, correcting validation errors, or providing any missing data. For unidentified documents, the option to perform manual data entry is available.
5. The system then converts the AE data into a format compatible with Oracle Argus Safety, to which the data is transmitted.
6. Depending on whether Oracle Argus Safety is configured to accept data automatically, the data will be converted to case or will be marked for manual case acceptance.