MedWatch Reporter

MedWatch Reporter allows electronic copies of FDA MedWatch Form 3500A for serious adverse events to be created, stored, and printed.

The forms generated by this program comply with FDA specifications per 21 CFR 310.305(d)(3) and have been approved for use in place of the preprinted MedWatch Form 3500A for reporting adverse experiences for drugs and medical devices.

This program is fully compliant with 21 CFR Part 11, including audit trails for all entries, multiple security levels, and the ability to electronically sign each record.

In addition, the program provides the ability to track all copies of each MedWatch Form 3500A distributed, including the date the form was sent and to whom.