Understanding Auditing and Electronic Signatures in Multiple EnterpriseOne Path Codes

This appendix describes how to set up multiple EnterpriseOne path codes for auditing and electronic signatures in support of the FDA 21 CFR Part 11 regulation.

You can configure auditing and electronic signatures in EnterpriseOne 9.0 for multiple path codes. This configuration enables you to mimic or test auditing in a "validation" path code prior to promoting changes (auditing or otherwise) to your production environment.

Important: Auditing of system tables is NOT supported because system tables are shared across multiple path codes. You cannot enable auditing on a system table in one path code when the same system table is already enabled for auditing in another path code.

Note: With Tools Release 9.2.8, you can enable auditing of system tables and all the tables in Object Librarian data source that are shared across multiple path codes. For details, see “Understanding Auditing for Shared Tables and Objects Across Multiple EnterpriseOne Path Codes (Release 9.2.8).”

This appendix provides the technical requirements associated with this type of a configuration as well as the effects the configuration has on some of the standard EnterpriseOne administration processes, such as change control, data refreshes, ESU applications, and so forth.

Hereafter in this appendix, the "auditing and electronic signatures" functionality is referred to simply as "auditing" or "21 CFR Part 11."