Electronic Records 

Purpose

The US health authority, the Federal Drug Administration (FDA), requires companies in the pharmaceutical industry that want to launch their products on the US market to provide a detailed, complete, and traceable description of their production process. This also includes electronic data. The logging of changed data is a key prerequisite that must be met in order to comply with the regulations for Good Manufacturing Practice (GMP). These GMP regulations are part of the conditions for “regulated production”. They were drawn up by the FDA to achieve standardized guidelines for the production of drugs and medicines on the US market.

The Electronic Records component enables you to change logging settings easily, without the need for technical modifications, and to carry out an FDA-compliant evaluation of the changed data. The component enables you to:

·        Activate and deactivate logging for the required data elements, tables, and long texts specifically and without the need for technical modifications.

·        Determine for each object – in the case of corrections or a system update – whether you want to retain the logging settings that currently exist in the system, or make different logging settings for the newly imported data.

·        Use the evaluation function to find and display the changed objects according to certain criteria, and therefore carry out a GMP-compliant evaluation of the changed data.

Integration

SAP systems log data changes during change document creation and table logging. Logging can take place on two levels:

·        For individual table fields (data elements), by means of documentation in change documents

·        For whole tables, by means of table logging

Logging in change documents

Before the system can log data changes in table fields in change documents, you must ensure that:

·        The transaction in which the content of the table field can be changed is connected to change document creation

·        The table containing the table field exists in the connected change document object

·        Logging is active for the data element in the relevant change document

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 more information about change documents, see the SAP Library under 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. To enable this, you must set the system profile parameter rec/client to active in every client in which you want to carry out table logging. To use the logging in transports, you must enter r3transoptions = recclient="XXX" in the transport control profile. You can enter the same value for  XXX as for the profile parameter rec/client. For more information about client-dependent logging, see Client-Dependent Logging.

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

In the SAP system, many transactions, but by no means all, are connected to change document creation. To avoid reducing performance and memory capacity, do not log all data changes. You should only log those that need to be included in subsequent evaluations. Therefore, it must be possible to change logging of specific data elements/tables.