Electronic Records (SAP Library - Electronic Records)

Electronic Records

Purpose

With the function FDA 21 CFR Part 11 Enhancement on Electronic Records (abbreviated to Electronic Records below), you can:

Activate and deactivate logging for the required data elements, tables, and long texts specifically and without technical modifications.
In the case of corrections or a system update, determine for each object whether you want to retain the logging settings that currently exist in the system, or make different logging settings for the newly imported data.
With the evaluation function, find and display the changed objects according to certain criteria, and therefore carry out an evaluation of the changed data conforming to GMP.

Integration

During change document creation and table logging, the SAP R/3 System already logs data changes. Logging can take place on two levels:

For individual table fields (data elements) through documentation in change documents
For whole tables through table logging

Logging in change documents

In order for data changes in table fields to be logged in change documents:

the transaction in which the content of the table field can be changed must be connected to change document creation.
the table containing the table field must exist in the connected change document object.
logging must be active for the data element in the relevant change document.

Note

As not all data is relevant for every application, it does not make sense to activate logging for all data elements from the outset.

For further information on change documents, see the SAP Library, under mySAP Technology Components ® SAP Web Application Server ® ABAP Workbench ® Extended Applications Function Library ® Change documents.

Table logging

If the transaction that uses the changed data element is not connected to change document creation, the system cannot log the change made to an individual table field (data element). Instead it logs the whole changed table. For this to be possible, you must set the system profile parameter rec/client to active in every client in which you want to carry out table logging.

Note

Only system administrators can activate or deactivate the system profile parameter rec/client.

For further information on logging tables, see the SAP Library under mySAP Technology Components ® SAP Web Application Server ® Customizing ® Customizing System Settings.

In the SAP R/3 System, a lot of transactions, but by no means all of them, are connected to change document creation. For performance and memory reasons, it does not make sense to log every data change. You should only log those that need to be included in subsequent evaluations. It must be possible to specifically change logging of data elements/tables.