For manufacturers of medical devices or pharmaceutical products it is mandatory to validate computer systems. With the update of ISO13485 to version 2016 the validation of software used at operational level shall be performed according to a risk based approach (chapter 4.1.6). This topic plays also an increasing role during audits. AXXOS will support and assist you with Computer System Validation and optimization of respecting processes to fulfil these expectations. Important to know is that we fulfil the expectations of the MedTech industry and will not go beyond the necessary demands.
We would also like to assist you with the execution of validation of complex and simple systems, the pre- and post processing of audits and at the optimization of existing processes.