Long abstract
No 10: The Application of the Principles of GLP to Computerised Systems
No. 10 in OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring: The Application of the Principles of GLP to Computerised Systems Throughout recent years there has been an increase in the use of computerised systems by test facilities undertaking health and environmental safety testing. These computerised systems may be involved with the direct or indirect capture of data, processing, reporting and storage of data, and increasingly as an integral part of automated equipment. Where these computerised systems are associated with the conduct of studies intended for regulatory purposes, it is essential that they are developed, validated, operated and maintained in accordance with the OECD Principles of Good Laboratory Practice (GLP). |