Good laboratory practice (GLP) - Guidelines for the development and validation of spreadsheets

Abstract

Spreadsheets are widely used for the storage, processing and reporting of data. As these spreadsheets are associated with the conduct of non-clinical safety studies intended for regulatory submission, it is essential that they should be developed, validated, operated, maintained, retired and archived in accordance with the OECD Principles of GLP. The present document provides guidance, i.e. a basic strategy for GLP-compliant development and validation of spreadsheets. Different approaches can also be used, as long as they are compliant with the OECD Principles of GLP. The AGIT (Arbeitsgruppe Informations-Technologie) is a working group consisting of representatives from Swiss industry and Swiss GLP monitoring authorities that proposes strategies relating to information technology issues which can be put into practice by test facilities in order to fulfil GLP regulatory requirements. Copyright © 2011 John Wiley & Sons, Ltd.