Latest System Changes in the Electronic Biological Product Deviation Reporting (eBPDR) System

Latest System Changes in the Electronic Biological Product Deviation Reporting (eBPDR) System
This eBPDR reporting website is in use and is being upgraded continuously. CBER reviews the site periodically to ensure reliable access for data entry and retrieval of saved data. To facilitate user understanding of recent changes, the major upgrades made to the system are outlined below.

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Version 5.1.0 Release Information - Release Date 9/25/2009

Unfinished Reports Page
The eBPDR Creator; in addition to the eBPDR Submitter, can now access an Unfinished BPD AI Report. Previously, only the eBPDR Submitter had access.
The eBPDR Creator and Submitter may give one additional user access to a BPD AI report by selecting the user from the “Other Assigned Access” list and pressing the Assign Access button. The “Other Assigned Access” list contains users that are associated to your facility through their “My Establishment” page.
The Unfinished Reports page displays which users have access to your Unfinished BPD Additional Information (AI) Reports.
An issue was corrected that caused unfinished reports from different facilities having the same name to be grouped together on screen.
CLIA Facility Message
Upon selecting “New Report” for a CLIA facility, the system asks, “Is this facility actively registered with FDA? The user answering NO can proceed with creating the new report and is not required to answer the question again for that facility for 90 days. The user answering YES will see a screen requesting that registered facilities submit BPD Reports using their FEI number instead of their CLIA number.
eBPD Report – Reporting Establishment Information page
A display issue was corrected relating to double quote characters entered in the Telephone, Point of Contact, and Tracking Number fields.
The system provides user notification when a user entered email address value contains blank spaces.
eBPD Report – DeviationEstablishment Information page
When required to enter Deviation Establishment Information, the user must only enter a valid Establishment ID and ID Type and then press SEARCH. If the system recognizes the establishment, the establishment details will populate automatically.
eBPD Report – BPD Information page
The system provides user notification when a user entered date values are more than 300 days before the current date.
Added validations to ensure the database saves BPD Information page dates in mm/dd/yyyy format.
Corrected an issue that allowed saving of lower case characters in the BPD Code field.
eBPD Submitted Report / Receipt Confirmation
When viewing an eBPD Report Receipt Confirmation or Submitted Report, press “Please click here to print this report” for a printer friendly version.
The Recently Submitted Reports page allows sorting of listed reports by using up and down arrows next to each column name.
The eBPDR Creator and eBPDR Submitter id’s now display on each submitted report.
BPD Additional Information Collection Module
Please see “Unfinished Reports Page” changes listed above for an explanation of system updates relating to eBPD AI Report accessibility.
On the BPD AI - Updated Product Disposition page, Date Distributed and Final Disposition are not required for product rows where consignee notification equals NO or RN.

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Version 5.0.0 Release Information - Release Date 12/18/2008

Reporting Establishment Information Page
A new field called Submitter Email Address appears on this screen to capture the email address of the person entering the report. The field pre-populates with your CBER Online user account email address after creating a new BPD report using the ‘Create New Report’ button. To change the CBER Online account email address, access the CBER Online Main Menu and then press the Edit Current Account button.
Note: Unfinished reports created prior to this release will need the Submitter Email Address entered manually before submitting to FDA..

BPD Preview and Confirmation Report Pages
The 'Enter Another Deviation' functionality was modified to correctly pre-populate the first page of the next BPD report.

abrir aquí para acceder al documento FDA, que incluye todas las modificaciones desde 2002:
Latest System Changes in the Electronic Biological Product Deviation Reporting (eBPDR) System