How Logilab SDMS helps Laboratories to enable GLP Compliance – Part 1

INTRODUCTION

About GLP and its importance

Good Laboratory Practices (GLP) is a quality system concerned with Laboratories’ organizational process and conditions under which non-clinical, health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. This has been introduced by Organization for Economic Cooperation and Development (OECD) with the intention to promote data quality and guarantee data integrity. This White Paper covers how Logilab Scientific Management System (SDMS), a software product developed Agaram Technologies Private Limited, India, helps Laboratories to adhere and follow the Principles of GLP as applied to Computerized Systems in laboratories. Apart from other guidelines regarding quality research, the GLP Principles can be found in
the member counties of the OECD (except USA and Japan) for non-clinical, chemical and agrochemical research testing studies. The GLP principles intend to provide a secure research environment that protects raw data from manipulation during and after testing procedures. It incorporates all organizational structures of research procedures. This implies that GLP, not only regulates the personnel working in a laboratory or other research facility, but also applies to computerized systems and their device-specific requirements used for research purposes.

GLP and Computerized Systems

Throughout recent years there has been an increase in the use of computerized systems by Laboratories undertaking health and environmental safety testing. These computerized 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 computerized 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 GLP

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