An audit trail is a Secure, complete and time-stamped electronic recording of changes and user interventions in a system or process. The aim of an audit trail is to document all relevant activities in a traceable manner in order to ensure transparency, traceability and integrity of data. This is particularly important in regulated areas of industry, for example in the pharmaceutical, food and medical technology sectors.
In an audit trail, typically human intervention in a system is logged, This includes the configuration of parameters, the starting or stopping of processes, changes to settings or the manual operation of functions. The recording usually contains information such as Time of the action, user identity, type of change and, if applicable, the previous and new value. This means that it is always possible to trace who made which change and when.
An essential feature of an audit trail is its Tamper-proof. Entries must not be subsequently changed or deleted unnoticed so that the integrity of the documentation is maintained. This is a key requirement for quality assurance, internal audits and external audits by authorities or certification bodies.
In measurement and automation systems, an audit trail supports the compliant documentation of process and configuration changes. The software solutions from Delphin Technology offer basic functions for logging relevant user actions and thus create important prerequisites for documentation in accordance with the directive FDA 21 CFR Part 11, which defines requirements for electronic records and electronic signatures in regulated industries.
Thanks to the structured and traceable recording of system activities, an audit trail makes a significant contribution to Quality assurance, compliance and process reliability with.