- data that is too good to be true.
- discrepancy between the electronic data versus Raw data.
- dated do not match i.e in chromatograms versus actual analysis was performed.
- Integration parameters were not traceable and retrievable.
- integration parameters being different for standard versus sample in same injection run .
- audit trail are not turn on and lack of periodic review.
- injection sequence not properly documented, repeat analysis,picking the best results.
- Raw electronic data not containing a unique identifier and absence of clear guidelines.
- lack of basic access control and security measures allowing unauthorised changes.
- shared users login ,missing and disabled audit trail .
- lack of contemporaneous activity recording.
- failure to investigate data discrepancy.
- Testing into compliance e.g interim analysis and trial run .
- incomplete collection , retention and review of data for quality decisions.
- overwriting or deletion of original data .
-If sample angle is less than the threshold angle it indicates purity of the peak .
- if sample angle is greater than the threshold angle it gives improper peak purity.
-Sample contrast 53 degree, 10 degree and 0.5 degree.