\”CompliantPro: software solution for medical engineering other topics: national and international capacity/compliance requirements – CompliantPro: software solution for medical technology – other topics: national and international capacity/compliance requirements – CeramTec AG uses the CAPA / compliance software solution of the IBS AG a practice report of Hohr-Grenzhausen, September 17, 2009: IBS AG loads on October 06, 2009 to a specialist forum with the topic of corrective and preventive actions (CAPA) and compliance management for medical equipment\” according to Rottweil. Among the speakers is also Uwe Kemmer, production manager of CeramTec AG. The company has its headquarters in the Swabian Plochingen specializes on the production of high-tech products of high performance ceramics (such as producing artificial hip joints). CeramTec is part of Rockwood holdings, Inc. and already uses the CAPA / compliance software solution of the IBS AG. Also about the benefits and his experiences with CompliantPro, Mr.
Kemmer is the participants in his lecture inform. Moreover, the lawyer Philipp Reusch will indicate in addition to other speakers requirements all relevant national and international capacity/compliance. The event is free of charge for the participants. Export of medical technology products in the United States have the requirements of the FDA (food and Drug Administration) must be met. While the FDA demands including the usage of an effective corrective and preventive system of prior management action (CAPA). About 30% of deviations that are contested by FDA inspections go back to unimplemented or inadequately functioning capacity systems.
Following the warning letters statistics for medical devices of the FDA, deficiencies in the processing of the complaint and are the topic to find CAPA always in the TOP 3. Effective instrument of integrated and comprehensive error management is a CAPA / compliance software solution. CompliantPro helps to document all deviations, errors, and complaints on products and processes and to analyze them. The CAPA workflow is a closed-loop and can be adapted to company-specific processes.