Configuring Auditing and Electronic Signatures for Multiple Path Codes

Note the following items when configuring multiple path codes for 21 CFR Part 11:

• When auditing is enabled in EnterpriseOne, the system records changes, additions, and deletions to an audit table (otherwise referred to as a shadow table) to provide a tracking history.

• An audit table contains the columns used as the primary key of original table along with any other columns that you define.

• For every change to an audited column in an original table (Fxxxx), the audit table records:

  • Field that was changed.

  • Previous value in the field.

  • New value in the field.

  • Date and time of the change.

  • Other fields in the table selected for auditing.

  • Other fields in the table selected for recording.

  • Form, application, and version name used to make the change.

  • The user ID that made the change.

The following task provides high-level steps for configuring auditing and electronic signatures in multiple path codes in EnterpriseOne. For more detailed instructions about any particular step, refer to the appropriate sections in the main chapters of this guide.

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).”

1. Make sure that users are signed out of the EnterpriseOne installation that is configured for auditing and electronic signature approvals.

2. Use the Configuration Application (P9500001) to add the path code to enable auditing and electronic signatures. See Setting Up an Audit and Electronic Signature Configuration for a Pathcode.

3. Sign off and sign in to EnterpriseOne Windows client and restart EnterpriseOne services when 21 CFR Part 11 is enabled for one path code. Do this for all path codes for which 21 CFR Part 11 is enabled.

4. After enabling auditing and electronic signatures for a path code, use the Configuration Application (P9500001) to enable auditing for a table. See Configuring a Table for Auditing.

   Note: Provide a different name for the A table when the same table is enabled for auditing on multiple path codes. For example, if F0101 is enabled for auditing, provide the following names: For DV900 path code - A0101DVFor PD900 path code - A0101PD

   When you select a table, EnterpriseOne launches Table Design Aid (TDA) and automatically adds all primary key columns of the audited table to the audit table.

   If a default index does not exist, TDA creates one for the audit table and populates it with CFRGUID and B4ORAFTR.

5. After it completes, save the changes to the audit table.

6. Check in the audit table.

   Note: Before you copy the audit information, you have to promote the audit tables to the path code you are auditing.Remember to provide different names for audit tables when auditing multiple path codes, for example AXXX for one path code and DVXXX for another.