The OECD Principles of Good Laboratory Practice (GLP) are a managerial quality control system covering the conditions under which critical non-clinical health and environmental test studies on chemicals are planned, performed, monitored, recorded and reported. The quality of such studies is vital as they are the data upon which governments decide whether certain products are safe for human health and the environment.
Computerised systems play a large role in the testing of chemicals, ranging from simple devices like balances to more complex devices such as stand-alone PCs controlling lab-based instruments and complex systems like laboratory information management systems. OECD first published guidance in 1995 on how GLP Principles can be applied to computerised systems. Since then, there has been a significant increase in the use and sophistication of computerised systems in test facilities. Thus, revised OECD guidance was needed to keep pace with these changes.
Advisory Document of the Working Group on Good Laboratory Practice - Application of GLP Principles to Computerised Systems - April 2016
This new Advisory Document replaces the 1995 consensus document. It retains all of the key text from the original 1995 document, but includes new text to reflect the current state-of-the art in this field. This document introduces a life cycle approach to the validation and operation of computerised systems. It emphasises risk assessment as the central element of a scalable, economic and effective validation process with a focus on data integrity. The intention of this document is to provide guidance that will allow test facilities to develop an adequate strategy for the validation and operation of any type of computerised system, regardless of its complexity, in a GLP environment.