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AN ISO 9001:2015 CERTIFIED
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companyconnectc
Apr 24, 20225 min read
USFDA 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...
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companyconnectc
Apr 24, 20222 min read
FDA Observation of Excel Spreadsheets Validation
Observation 1. Your firm has not established and documented the accuracy, reliability and performance of your computer systems employed...
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companyconnectc
Apr 24, 20221 min read
FDA Observation on Validation of Computerized System
Observation Failure to maintain a written record and appropriate validation data of computer or other automated processes used to perform...
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companyconnectc
Apr 24, 20223 min read
Electronic Records – CSV FDA Warning Letters
Observation We remain concerned that your (b)(4) adverse drug experience reporting system has not been fully validated, and may have...
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