The US health authority – the Federal Drug Administration (FDA) – requires companies in the pharmaceutical industry that want to introduce their products on to the US market to provide a detailed, complete, and traceable description of their production process. This includes all operations affecting product quality that are carried out during the process of manufacturing and distributing a drug.

Naturally, the data that is created or processed during these processes is subject to frequent changes. The FDA requires every change to this data to be documented in a change log. In this log, all data changes must be completely traceable at all times. As a result, it must contain at least the change date and time, the type of change, the data value before and after the change, and identification of the person who made the change.

This change logging 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," and were drawn up by the FDA to achieve standardized guidelines for the production of drugs and medicines on the US market. They have since become a "quasi-standard" in many other countries. Adherence to the GMP rules during production of a drug, and, in particular, proof of this adherence, are absolute prerequisites for successful introduction of a product on to the market. Validation of the quality-relevant business processes is a prerequisite for obtaining product approval. This approval is, in turn, a prerequisite for introducing the product on to the US market.

Because of the increasing use of electronic tools, the FDA needed to develop guidelines for the logging of data changes in electronic media. These FDA activities led to the Final Rule 21 CFR Part 11 Electronic Records, Electronic Signature. In this rule, the FDA defines how changes in electronic data records are to be logged, so that these changes are traceable in line with the aforementioned criteria and can be evaluated if necessary taking account of particular factors.

The logging of data that currently takes place in the SAP R/3 System as part of change document creation does not satisfy all the FDA requirements. In particular, with the options currently available, it is not possible to evaluate the data to a sufficient extent or with the accuracy demanded by the FDA. In addition, it is extremely difficult to change the logging settings (logging yes or no).

The function Part 11 CFR 21 Enhancement on Electronic Records extends the previously available options so that logging settings can be changed easily and without technical modifications, and that evaluations of the changed data can be carried out in line with FDA requirements.