Hello everyone, I have some doubts about the validation of spreadsheets. In my previous company, auditors said that an spreadsheet could not be validated.
I know that an important point is that an spreadsheet doesn´t generate an Audit trail.
There are other important points to keep in mind?
Thanks!!
About all you can do is validate that the formulas, etc. that you use are correct.
If you need Part 11 compliance (with audit trail, etc.) then you need some add-on software (I don’t have any specific recommendations).
let me know what exactly you want to validate in the excel spread sheet. give me details may be i can help:)
We have had many clients that were cited for not validating Excel spreadsheets.
cGMP’s specifically mentions that where spreadsheets are used they must be validated. So there are no grey areas.
There are spreadsheets available that are validatable. I would advise all to use them and stick with them.
The audit trail and retention of records are just some of the problems with Excel. Excel at certain stages will round calculations up or down, without advising the user. This can be a serious problem and can inhibit the validation process.
Alex Kennedy
[quote=alexkennedy]We have had many clients that were cited for not validating Excel spreadsheets.
cGMP’s specifically mentions that where spreadsheets are used they must be validated. So there are no grey areas.
There are spreadsheets available that are validatable. I would advise all to use them and stick with them.
The audit trail and retention of records are just some of the problems with Excel. Excel at certain stages will round calculations up or down, without advising the user. This can be a serious problem and can inhibit the validation process.
Alex Kennedy
[/quote]
Alex is right, Excel spread sheet must be validated.
ya excel sheet must be validated.
all u can do that just prepare a sheet comparing the values obtain from calculator and excel sheet. that should meet.
2. the sheet should be protected and no one could be able to change the content except one person having password
3. all the cells should be protected except those in which u have to enter the input values
4. cut and paste should not be allowed in these sheet.
i have done it and its working
Usually spreadsheets are used for Process Monitoring and reporting (macros). People become very creative using excel and developing complex tools to make GMP decisions.
Audit trail, security, and record retention are necessary. I recommend using an application like “DACS” to control the spreadsheet, and then validate the configuration, including any sort of coding for reporting.
If your site has a lot of spreadsheets, then validate a process (using a SOP) to create, control and maintain them. In addition, try to have them all in a qualified controlled server.
The most important thing when using spreadsheets is that you are not supposed to used them to make GMP decisions if you don’t have them under control.
Hope this helps,
Edgardo