[Computer system validation. The quality assurance procedure].
The use of computerized systems in preclinical studies has increased over the last ten years. This fact has caused dramatic changes in the way raw data are used in studies. Regulatory authorities, in fact, now require that computerized systems used during preclinical studies be validated. Quality assurance was given the task of organizing an approach to this challenge. Above all, this process applies to all company functions, from test facility management to technical staff. Moreover, various systems may be encountered during the process where the operating systems and the technologies used may be different. Another difficulty may be the lack of resources, changes requested by users or regulatory updates of legislation. Last but no least, archiving should not be underestimated.
Sforza
Valentine Anthony
VA
Pharma Quality Europe Srl., Via Dodecaneso 11, 00144, Roma. v.sforza@pqe.it
D019411:Clinical Laboratory Techniques / Q000592:standards*; D003199:Computer Systems / Q000592:standards*; D004353:Drug Evaluation, Preclinical / Q000592:standards; D005568:Forms and Records Control; D019983:Guideline Adherence / Q000331:legislation & jurisprudence / Q000458:organization & administration; D007558:Italy; D008330:Management Audit; D008722:Methods; D011786:Quality Control; D012106:Research / Q000331:legislation & jurisprudence / Q000592:standards*; D012107:Research Design; D014116:Toxicology / Q000331:legislation & jurisprudence / Q000592:standards