Siebel Adverse Events and Complaints Management -- eMDR, Statement of Direction
(Doc ID 550038.1)
Last updated on DECEMBER 19, 2019
Applies to:Siebel Adverse Events and Complaints - Version 188.8.131.52 SIA  to 8.0  [Release V7 to V8]
Generic (Platform Independent)
Information in this document applies to any platform.
Electronic Medical Device Reporting (eMDR)
Electronic Medical Device Reporting is one of several key enhancements planned for Oracle's Siebel Adverse Events and Complaints Management module. Currently, submission of mandatory FDA reports is done manually via U.S. Postal service or other parcel carriers. This process is slow, inefficient, and provides no acknowledgement that reports were received. To make this process more efficient the FDA is moving towards automating the way these reports are submitted, received, and acknowledged -- the process referred to as electronic medical device reporting or eMDR.
Oracle plans to release eMDR functionality for v7.7 and all forward releases starting in 2008.
Key features planned include:
- Individual or Batch report transmission option
- One-button eMDR transmission
- Transmission and FDA Status Visibility
Download the attached PDF Statement of Direction / Planned Features document.
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|Electronic Medical Device Reporting (eMDR)|