All measurements are saved to file and stored in a run trace-ability database. Figure IV shows an example of the “Run Trace-ability” tool of the DRIFTCON software. To each measurement a unique test number is assigned. All relevant data such test date, cycler identification etc. is stored with the run trace-ability.

This figure show the “Analysis Result” of a specific measurement of a certain type of instrument. The results are calculated at several temperatures and at certain time positions. For each parameter (spread and accuracy) the measured value and specification value are calculated and displayed. The result of the measured value is also indicated.

This image shows results at a temperature of 70° Celsius.

One of the strongest features of the DRIFTCON software is that for every temperature hold in the test protocol, parameters and data for each individual channel are calculated simultaneously. All results and data collected and used in the reports cannot be modified, which is an important issue in GLP/GMP/FDA and other Quality Programs. Depending on the “user operation level” the thresholds are adjustable during the analysis. DRIFTCON’s default threshold settings are based on average ‘field specifications” (market results). A user can select drift and/or accuracy as well as the temperature and time as parameters that will be used in the calculations.

This image shows the “drift” results of the thermal cycler selected above. The figure shows the overview of the accuracy and the uniformity of the instrument. It has been tested 26 times in total. After measurement 14 the performance of this cycler has substantially improved. It has been repaired at that particular time.

This picture shows a magnification of performance improvement started at DRIFTCON validation #14. Diagnostics users could use the instrument from that date on again!