A deviation triggers a highly sensitive process in medical technology: The person in charge of quality is obligated to implement a CAPA process. As such, he systematically averts damages and, at the same time, contributes to strengthening the company processes. The QM software from Babtec now supports this process with a separate CAPA module. All branches of industry can now profit from this integrated solution.
CAPA (Corrective Actions, Preventive Actions) designates the systematic examination of deviations. The goal is to avoid another occurrence using corrective and preventive actions. In medical technology, the CAPA process is clearly defined by regulatory requirements, e.g. by the US-American Food and Drug Administration (FDA). The large majority of European manufacturers of medical technology exports to the United States. For this reason, these guidelines are also binding for them. A new software solution from Babtec is now available for this process that is often performed manually.
The CAPA module in the Babtec.Q software guarantees the standard-compliant implementation of the requirements. The entire CAPA process is mapped in a transparent and standardized way: Previously defined rules, events or ratios – e.g. complaints or audit deviations – trigger the CAPA process. An analysis of the causes follows. Thanks to the structured procedure, they can be identified very quickly and their risks can be assessed. This ensures a timely implementation of effective corrective actions as well as long-term preventive actions for the future avoidance of errors. Important decisions are logged with electronic signature and in a complete and reproducible way in the CAPA history by the integrated audit trail.
The CAPA module from Babtec completes the quality control loop while offering all the advantages of an integrated QM solution. Other branches of industry can also profit from this economic application: "Beyond the regulatory aspects in medical technology, the strategic implementation of CAPA management reinforces the continuous quality improvement";, as Michael Flunkert, Manager of Babtec GmbH, explains. "By systematizing the procedure for avoiding errors, the damage can effectively be averted and the entire company can be strengthened over the long term."