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Computer Validation in Clinical Research: Regulatory Requirements in the European Community

Although the Commission of the European Communities' (CEC) good clinical practice (GCP) guideline refers to computer validation, the impact of the reference has not been fully understood in the clinical research area. A compilation of points to address, mentioned in the CEC GCP guideline and in the CEC good manufacturing practice (GMP) guide, has been made to facilitate the estimation of tasks in this area. It is important to realize that there are recognized, acceptable, validated methods, other than those described in the guidelines, which are capable of achieving the principles of quality assurance. Companies should implement appropriate systems not only because of the possibility of inspections, but also because of their ethical concerns and pursuit of excellence.