Spreadsheet Validation Issue

COMPUTER SYSTEM VALIDATION (CSV) 21 CFR PART 11
1

Hi Guys,

Here’s the situation, we have an equipment on a manufacturing line that produces critical manufacturing data.

The data is generated in a CSV file and this file is then automatically transferred to a secure location on the network drive.

My questions is, if someone has access to this file they have the ability to change the data, and no audit trail is in place for this CSV file to track the change.

A remediation project is going to happen in 6 months to implement a Part 11 solution in order to make this spreadsheet compliant.

In the interim apart from restricting access to these files what can we do if anything to fully protect the information in this spreadsheet.

Regards

2

Graham,

Would a checksum program help? We use something called MD5sum. You can feed it any file and it generates a 32-char string representing the checksum. You could always then compare the current CSV file checksum with the original to determine if any changes were made. Of course, you’d have to protect the original checksum value some way.

It won’t protect the file but will sure let you know if something changed.

3

Hi Yodon,

Thats great information, did realise that existed.

Very helpful

Cheers