Creating Data Sheets

Packaged medications (like prescriptions) are marketed with an insert sheet that lists the known contraindications (side-effects) that may occur as a consequence of taking the product. These inserts are also referred to as data sheets. It is important to list these effects in order to ensure accuracy in reporting. An inaccurate report could result in the wrong action taken or bring harm to a patient.

The Listed Events & Indications from the data sheet determine the listedness of the adverse event(s) for the case. Depending on the configured regulatory report rules, the listedness determination will automatically schedule the expedited reports.

The data sheet in the Product Family is configured using the Business Configuration > Products Family section.