Bioequivalence and Bioavailability Forum

Dear Sir
During a QA audit, we have encountered the following situation regarding accuracy calculations for the SCC and QCs. Where discrepancy between manual calculation and LC-MSMS generated software calculations printout (Waters API 3000) gave two different results, where:
Case 1): Manual calculations using one decimal place for calculating accuracy gave a result at the LLOQ “SCC” of 20.00% accuracy (i.e LLOQ meets the acceptance criteria of <20.00%)
Case 2): Automatic software calculations for accuracy gave a result at the LLOQ “SCC” of 20.50% accuracy (i.e LLOQ fails to meet acceptance criteria of <20.00%)
Same applies with QC calculations.
This was seen when the accuracy result is on the border-line of the limit
The above-mentioned case was noted in 17 volunteers from 76 volunteers’ analysis.
Kindly advice what action(s)/step(s) should be taken to solve this dilemma? And how do you solve such a discrepancy in results? And how would European authorities look at such a case?
Appreciating your feedback
Thank you and best regards
Najat