Quality auditing of chromatographic data.

We have developed a method for consistent, in-depth audit of the integrity of chromatographic records. The approach includes definition of the analyte, the method of analyte sample preparation and analysis, and the analyte concentration range. Acceptance criteria (if any) defined in the protocol or method are compared to the data. Run parameters are compared to those specified in the methodology. Certification of the standard is verified and the limit of quantitation for each run is identified and compared to data. Reasons for data discard and/or reassay are examined. If calculation software is not validated, representative calculations are recomputed and chromatograms are examined for attributability. These parameters are examined in addition to other Good Laboratory practice considerations such as sample identity, sample integrity, and transcription accuracy.