Title :
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
Author_Institution :
Romanian Bur. of Legal Metrol., Bucharest, Romania
Abstract :
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.
Keywords :
ISO standards; formal verification; information management; laboratories; medical information systems; ISO standard; LIMS; SR EN 15189:2013 standard; SR EN 17025:2005 standard; gas meter; medical laboratory information management system; software validation; software verification; testing laboratory; ISO standards; Protocols; Quality assurance; Software tools; Testing; SR EN 17025:2005; SR EN ISO 15189:2013; gas meter; medical analyzer. LIMS; software validation;
Conference_Titel :
Advanced Topics in Electrical Engineering (ATEE), 2015 9th International Symposium on
Conference_Location :
Bucharest
DOI :
10.1109/ATEE.2015.7133899
