CHAPTER 17: Second Person Review Check Access

A second person review is an essential part of the four eyes principle that is used in all GXP disciplines to ensure that work has been conducted correctly and that the results are correct. A suitably qualified peer scientist is used to check that an analysis has been carried out correctly, e.g. the analytical procedure and applicable SOPs have been followed, all data have been collected and interpreted and that the reportable result is correct. Furthermore, checks must be made to ensure that data have not been deleted or falsified, as required by several data integrity guidance documents. Second person review is a critical part of the analytical process, especially where the interpretation of data is involved, e.g. spectroscopic or chromatographic analysis. The role of the second person reviewer is to ensure that data interpretation is scientifically sound and that interpreting, testing or falsifying into compliance has not occurred. Owing to the wide range of analytical procedures, this chapter will consider second person review from the perspectives of a and test by observation, a manual process with paper records, a hybrid system and an electronic process utilising electronic signatures. When reviewing records generated by either hybrid or electronic computerised systems, this will include relevant audit trail entries. Note, even for electronic systems there may be paper records to review such as instrument log books or sample preparation records.