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Start back up activity and to define the directory for data archival.To view audit trail logs created by level 1 & to feed necessary comments.Having all rights and controls pertaining to the application.To back up the required data, as & when required.Monitor data security & supervise data archival system.To monitor audit trail logs & comments, which are created by level 1& 2.The typical privileges assigned to user groups may be as follows.Closed System: System access is controlled by persons who are responsible for the content of electronic records.Open System: System access is not controlled by persons who are responsible for the content of electronic records.User Group: Applications or data acquisition software installed shall be accessed through the following user groups.Electronic Signature: A computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature.Īlso read: SOP for Maintenance of Laboratory Instrument.Review and approval of audit trail information.ĥ.0 ABBREVIATIONS USED IN SOP FOR AUDIT TRAIL:.Review any changes made to the assigned privileges or user groups.Ensure that privileges assigned to user groups and system policies in data acquisition systems are in line with the requirements.Ensure only licensed applications are installed in GLP mode for data acquisitions.Implement necessary technical controls to the required applications/ operating systems.