ABSTRACT
Computer systems are widely used in analytical laboratories for instrument control, data acquisition, data evaluation, document generation and archiving, and information management. The correct functioning of software and computer systems should be verified after installation and before and during routine use. Regulatory agencies pay much attention to the validation and use of computers in the regulated environment. For example, the EU guide to GMP has an appendix focusing on using computers in GMP environments (41). FDA regulation for electronic records and signatures (42) requires validation of computer systems used in FDA-regulated environments and the OECD GLP consensus paper number 10 (58) requires acceptance testing, which is part of an OQ. Furthermore, PIC/S has published a 55-page good practices guide on using computers in GxP environments (21).
