Audit trail
An audit trail (Latin: audire: to hear) is a quality assurance tool and is used to control and record changes that are made in processes. Compared to known monitoring systems that continuously monitor certain processes, the focus of audit trails is on monitoring changes and deletions by users. Interventions in processes for downstream levels in supply and value chains are understandable, controllable and seamlessly visible.
construction
Recorded audit logs should include the following information:
User: Users are the people who are responsible for creating, changing or deleting data. In the system, the user ID is assigned to the change process in order to document responsibilities and assign them later.
Event: A change in the normal state, active intervention in the system or error messages are defined as an event in the audit trail. In practical terms, it includes everything that means a deviation from the specified parameters and tolerances.
Data: The data relate to a previously occurring event (see above). The audit trail system saves the changed data.
Time stamp: Time stamps are automatically set by the audit system when the user intervenes. For this purpose, the system time is updated at regular intervals via a "time server".
System / device: In addition to the date and time of the user intervention, if several devices write to a log file, the device used must be clearly identifiable at all times. In addition to the device / system name, the IP address and session are usually also saved for this purpose.
Reasons: The system automatically enters the user ID, system data, type of change, change data and the time of the change. The user usually only has to manually write a reason for the change / deletion. Reasons give third parties a quick overview of why changes have been made when viewing the log file.
Use in practice
The increasing demand from industry and trade for more transparency across the entire supply chain in combination with the clear clarification of responsibilities for interventions and changes leads, particularly in the pharmaceutical and automotive industries, to wanting to closely monitor interventions. In the pharmaceutical industry in particular, interventions and changes in highly sensitive goods and materials can have extreme effects on their condition and quality. In order to minimize and detect quality losses in terms of effectiveness and contamination, the intervention logs recorded in the audit trail can be requested and viewed at any time for downstream stages in the supply chain. Due to the qualification prior to commissioning the systems, manipulations are not possible.
Individual evidence
- ↑ Definition: Audit Trail . In: Gabler Wirtschaftslexikon Online . ( gabler.de [accessed on July 9, 2018]).
- ↑ Johner Institute: Audit Trail: What you should know as a medical device manufacturer . In: Knowledge of Medical Software . July 12, 2016 ( johner-institut.de [accessed July 9, 2018]).