Observation 1. Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized...

Observation 1. Your firm has not established and documented the accuracy, reliability and performance of your computer systems employed...

Observation Failure to maintain a written record and appropriate validation data of computer or other automated processes used to perform...

Observation We remain concerned that your (b)(4) adverse drug experience reporting system has not been fully validated, and may have...