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