Reports in Microsoft Word and Excel

COMPUTER SYSTEM VALIDATION (CSV) COMPLIANCE SOFTWARE
1

Hi

Our software generates reports in Microsoft Word and Excel.
I’m working on making our software meet requirements to fit into a
Part 11 compliant environment.
If it is expected that these Word and Excel reports will be moved to
the customers centralized document management system after they are
generated is there anything I need to do (or should do) to help make
sure these Word and Excel documents are kept in compliance?
I will keep an audit trail and control access to the software that
generates these files but after they are generated is there anything I
can/should do?

Thanks

2

Hi Orlando

I think it would be wise to offer a little more than simply ‘placing
the responsibility on the user’. There are possibly a few simple
optional controls that you could add to mitigate the risk of report
alteration between generation of reports and placement in secure
environment (possibly a document management system, but what about the
many companies who dont have one?)

A few thoughts:

  • Generate pdf files rather than Word/Excel (could be via VBA Macro in
    Word/Excel).
  • Password protect the generated report files.
  • If the end-user requires further ‘manipulation’ of the reports (eg
    additional Excel Calculations) you could offer a third party add-in to
    provide Part 11 controls - eg see
    www.spreadsheetvalidation.com
    .

Regards

3

There are couple of companies that offer you add-ons so as to make excel Part 11 compliant. Why reinvent the wheel??? The one used by ABB/Wimmer Systems is something that I have used and not had any issues with.