CONTACT Elements provides a generic function for product manufacturers that largely automates legally compliant documentation and relieves developers of time-consuming routine tasks. Audit trails collect regulatory important data and their changes in the product life cycle and record them seamlessly and chronologically.
During market approval, certification or in the event of damage: A manufacturer must always be able to prove that his products and processes meet technical, qualitative and regulatory requirements. Compiling the documents required for this often causes high efforts in the companies.
PLM systems facilitate legally compliant documentation through version and change control. CONTACT Software goes a decisive step further: A new service of the CONTACT Elements platform also offers an audit trail, which keeps detailed and automatic records of regulatory relevant information. This relieves users of routine tasks and helps the manufacturing industry to optimally comply with its burden of proof.
Audit Trail tracks changes and highlights the delta, for example on a document.
Companies can easily configure which business objects such as requirements, articles or documents should be considered by the audit trails. Starting with the new creation of such an object and all subsequent changes down to attribute level, a complete digital change history is generated along the time axis. The corresponding data can be visualized and evaluated within the framework of dashboards, reports and APIs in further business processes.
"Audit Trails document all regulatory relevant changes and thus create transparency about all actions carried out", summarizes Dr. Regine Wolters, Product Manager PLM at CONTACT Software, the benefits. "This automatic service frees the companies and their employees from an enormous amount of bureaucracy when it comes to certifications or market approvals."
