Use of spreadsheet or calculator

Validation
1

Dear Team / Learned professionals pl. advice on the below query

In QC laboratory we do HPLC analysis for assay of Finished products. After the analysis to perform calculations
a) Can we use physical calculators to determine the results
b) Is there a need to have validated Spreadsheet to do the above calculations – why cannot use calculators
c) If a validated spreadsheet is prepared. It is okay to store the validated spreadsheet in server from where analysts can download a copy of the spreadsheet to their own computer. Then perform the calculation using the downloaded spreadsheet. Once results have been determined. Then Delete the spreadsheet. Is this acceptable.

Regards

2

You have to keep all records. Read FDA 210 cfr part 11

3
  1. U use scientific calculators in QC. To pre pare one protpcol for calibration of calculators based on that u perform calibration. Recalibration frequency also I assign.
  2. About excels also u prepare p rotocol for excel validation. U prove the excel result and manual calculation results are same. After that u prepare the validated excel sheet. In that u lock all the cells and give provision to enter the values only.