Good Laboratory Practice (GLP) ‐ guidelines for the acquisition and processing of electronic raw data in a GLP environment

Abstract

The aim of the present document is to provide guidance on the Good Laboratory Practice (GLP)-compliant acquisition and processing of electronic raw data. The life cycle of electronic raw data and their related meta data from the data acquisition to the data processing and the generation of results is shown. The different roles and responsibilities for data entry, data editing, data approval, and data freezing are specified. The requirements for time stamps, audit trails, and the identification of acting persons are described. Furthermore different levels of laboratory instrument integration in a LIMS are discussed. This document is intended to aid test facilities, and to promote the use of a common standard, but it should not be considered as a legally binding document. These guidelines may evolve with experience over the next few years and may be modified to reflect interpretations made by other Organisation for Economic Co-operation and Development (OECD) member countries. The present guidelines were prepared by the Working Group on Information Technology (Arbeitsgruppe Informationstechnologie, AGIT). This group consists of representatives from Swiss industry and the Swiss GLP monitoring authorities. Copyright © 2006 John Wiley & Sons, Ltd.