Software validation with respect to requirements specified by SR EN 15189:2013 and SR EN 17025:2005. A practical approach for a medical laboratory information management system (LIMS) and a gas meter in testing laboratory

Most of nowadays equipment that are to be found in modern test laboratories and medical laboratories use complex computer systems and software tools. In many cases these systems are part of the equipment itself and are validated by the manufacturer. However, in many cases testing laboratories perform post-processing operations by means of an in-house built software tool. In case of medical laboratories, the applicable ISO standard has specific requirements regarding the information system. The paper introduces a novel strategy and practical examples regarding software validation and verification from the fulfillment of SR EN ISO 15189:2013 and SR EN ISO 17025:2005 specified requirements.