companyconnectcApr 24, 20225 minUSFDA 483 on Access Management of Computerized System Observation 1. Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized...
companyconnectcApr 24, 20222 minFDA Observation of Excel Spreadsheets Validation Observation 1. Your firm has not established and documented the accuracy, reliability and performance of your computer systems employed...
companyconnectcApr 24, 20221 minFDA Observation on Validation of Computerized SystemObservation Failure to maintain a written record and appropriate validation data of computer or other automated processes used to perform...
companyconnectcApr 24, 20223 minElectronic Records – CSV FDA Warning LettersObservation We remain concerned that your (b)(4) adverse drug experience reporting system has not been fully validated, and may have...
