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 provides multiple options for ingesting AE documents, including manual uploads, automatic uploads via API, email, or Electronic Data Interchange (EDI).

Note:

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

1. Via email, API, Electronic Data Interchange or through direct user upload, documents are ingested by Oracle Safety One Intake.
2. As part of this step, Oracle Safety One Intake marks records that require manual review - this may involve reviewing and confirming extracted information, correcting validation errors, or providing any missing data.
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 checks the document against other, already ingested documents, marking it for Duplicate Search or Merge Follow-up. Users manually compare the data of records with these statuses, then either accept or reject them..
6. If the target system is configured to accept data automatically, the data will be converted into a new case or will be merged with an existing one.