Windchill CEM – MedWatch Follow-up process enhanced in the following ways:
a. Users to have the ability to optionally revise the regulatory reporting decision; this process must not obscure the previous decision made for the Initial or previous Follow-up report decisions.
b. Users to have the ability to capture the Become Aware Date for Initial and Follow-up reports where the date captured on a follow-up is not obscured and is readily visible to the user.
c. Users to have the MedWatch Follow-up report data entry screen default as ‘blank’. Current OOTB functionality is the data from the Initial report is carried into the follow-up; and you only see the ‘differences’ when doing a Print-Preview. Users must ‘override’ the copied data for the differences. Possible solution is to have a toggle view that allows both views available to the user via a toggle.
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