Spreadsheet can be used to record and manipulate (change, delete, add) GxP data and as such need to be managed to ensure the continued integrity and security of that data. While some are no more than fancy calculators’ others are embedded with special features and use intricate logic in the form of Macros that are in effect computer programs.

Spreadsheet 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. Spreadsheets which fall into GAMP Category 5 guidelines do not require full validation activities but should be held under appropriate security conditions. 

Our Spreadsheet processes typically involve:

• Functional Requirement Development
• Spreadsheet Application Development
• Qualification Procedure
• Training
• Re-qualification of Spreadsheet application Formula