research |development
audit trail logging system
design and implementation of an audit trail logging system using the example of a medical device manufacturer
this work deals with the “design and implementation of an audit trail logging system” using the example of a medical device manufacturer.
by using intelligent sensors on machines, more and more data is being collected and evaluated by it systems in order to make processes more efficient, economical and transparent.
the processing of data in real time enables seamless traceability and control along the entire value chain, which significantly increases product safety and product quality. for companies in the medical technology sector, the logging of relevant machine operations, changes to important process parameters and errors and their correction is even required by law.
manufacturers can guarantee the quality of their products by regularly monitoring the recorded events. while the reports on operating processes (audit trails) as well as error and alarm messages are already being generated automatically, the process of control has not yet been completely digitalized. this bachelor thesis shows how potential can be used here. the thesis consisted in creating a system that reports audit, alarm and actual value reports of all around 40 special machines on a central storage location. the challenge was to connect the different and sometimes older control and software systems equally.
the data storage is carried out in such a way that all messages are available in a uniform format and can be further processed as easily as possible. by providing the data in an uniform manner, they can be used for further analysis purposes. for example, the actual values in models for predictive maintenance or the alarm messages can be used for statistical error evaluations. the collection, processing and storage of the messages meets the high standards of reliability, security and traceability and all regulatory requirements.
