𝔖 Bobbio Scriptorium
✦   LIBER   ✦

Good Laboratory Practice (GLP) – Guidelines for the Development and Validation of Spreadsheets

✍ Scribed by Peter M. Esch; Christoph Moor; Beat Schmid; Silvio Albertini; Stephan Hassler; Gérard Donzé; Hans Peter Saxer

Publisher
John Wiley and Sons
Year
2010
Tongue
English
Weight
682 KB
Volume
13
Category
Article
ISSN
1087-8378

No coin nor oath required. For personal study only.

✦ Synopsis

Summary

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.

📜 SIMILAR VOLUMES

A lesson plan for the enhancement of tra
A lesson plan for the enhancement of training and research in academia by the adaptation and adoption of good laboratory practice guidelines
✍ Ramakrishnan Sitaraman 📂 Article 📅 2010 🏛 The American Society for Biochemistry and Molecula 🌐 English ⚖ 58 KB 👁 2 views

## Abstract The implementation of good laboratory practices (GLPs) is recognized by the biotechnology and pharmaceutical industries as being critical for ensuring the international acceptability of products. However, as universities and colleges (and research organizations) do not necessarily work

Issues in the development of practice gu
Issues in the development of practice guidelines for inflammatory bowel disease
✍ Dr. William J. Tremaine 📂 Article 📅 1997 🏛 John Wiley and Sons 🌐 English ⚖ 331 KB 👁 2 views

## A Practice guidelines for inflammatory bowel disease (IBD) should address the unique needs and challenges of the patients, to improve not only the quality of medical care but also the quality of life.