Warning Letter: Mishandling and retrieval of electronic data (ucm393093)

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Ofni Systems

Your firm failed to establish SOPs describing the handling and retrieval of electronic data. Handling of electronic data includes the security (e.g., audit trails) and statistical analysis of raw data. Specifically, the SOP for handling electronic data should describe a procedure for the archiving of multiple statistical analyses of the clinical pathology raw data with the study records. For Study [redacted], multiple sets of statistical analyses were maintained on the firm’s electronic server, and were not archived appropriately.

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