What are the requirements for documenting manual integrations for initial and continuing calibration (Box #50 and #57, Sections 5.5.2.2.1 and 5.5.10)?
EDQW Response: The data reviewer or user must be to be able to completely reconstruct chronological events leading to the final manually integrated chromatograms. Many software packages for audit trails do not allow full reconstruction and capture of “before” chromatograms. In those cases “before” chromatograms must be provided along with other information specified in DoD Box 50.
Related Questions
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