Validating excel spreadsheets
The procedures to be used for subsequent sorting or rearranging of the data via the spreadsheet application should be described.5.2.4 Macro Programming Frequently performed tasks may be automated by recording them as macros and playing them back whenever necessary.5.2.1 Raw Data Considerations The Spreadsheet Application Developer must define how data will be entered.Data can be inputted directly from instruments (or data files) into a spreadsheet application or data can be entered manually.
5.2.2 Formula Development Each formula described in the Requirements Documents must be embedded in the spreadsheet application.
Spreadsheets can be classified into GAMP categories depending on use and contents of the spreadsheet.
This will impact the level of validation effort that is applicable just as with other computerized systems.
He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11, 21CFR Part 111 and Validation around the world.
This included seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national health care agencies.
The formulas must be checked for errors during development.