This paper reviews various good clinical practice (GCP) regulations for their computer validation content. It examines ISO 9000 quality standards as potentially useful in building validation plans and standard operating procedures (SOP) under European Commmunity (EC) GCP. Then it looks at the EC good manufacturing practice (GMP) computer guidelines and discusses in some detail how computer hardware and software vendors can help pharmaceutical companies address their system validation needs.
EC CPMP.Good Clinical Practice for Trials on Medicinal Products in the European Community. Brussels, Belgium: Commission of the European Communities; 1991: 22–23.
2.
Ibid. p. 9.
3.
TGA.Guidelines for Good Clinical Research Practice (GCRP) in Australia. Woden ACT, Australia: Commonwealth Department of Health, Housing and Community Services; 1991: 28–29.
4.
Guide to Inspection of Computerized Systems in Drug Processing. Rockville, MD: U.S. Food and Drug Administration, Dept. of Health and Human Services; 1983: 25.
5.
ISO.Quality Management and Quality Assurance Standards—Part 3: Guidelines for the application of ISO 9001 to the development, supply and maintenance of software. Reference Number ISO 9000–3:1991(E). Geneva, Switzerland: International Organization for Standardization; 1991: 3.
6.
Ibid. p. 2.
7.
Guide to GMP: Supplementary Guidelines for Computerized Systems. Brussels, Belgium: Commission of the European Communities; 1989: 2.
8.
Ibid. p. 2.
9.
TimbersMJ. ISO 9000 and Europe's Attempts to Mandate Quality. J European Bus. 1991;2(6): 19.
