Background Information on Audit Trail

Concept

The US health authority, the Federal Drug Administration (FDA), requires enterprises in the pharmaceutical industry wishing to market their products in the USA 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 therefore requires each change in such data to be documented in a change log. In this log, all data changes must be completely traceable at all times. The log must therefore contain at least the date and time of the change, 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 satisfied 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 uniform 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 the successful marketing of the product in the USA. Validation of the quality-relevant business processes is a prerequisite for obtaining product approval. This approval is, in turn, a prerequisite for marketing the product in the USA.

Because of the ever-increasing use of electronic tools, the FDA needed to develop guidelines for the logging of data changes in the 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 system as part of change document creation does not satisfy all the FDA requirements. In particular, it is not possible to evaluate the data to a sufficient extent or with the accuracy demanded by the FDA with the options currently available. In addition, it is extremely difficult to change the logging settings (logging yes or no).

The Audit Trail function 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.