✦ LIBER ✦
Laboratory software validation — from corporate policy to bench top systems
✍ Scribed by Teri Stokes
- Publisher
- Elsevier Science
- Year
- 1995
- Tongue
- English
- Weight
- 895 KB
- Volume
- 31
- Category
- Article
- ISSN
- 1381-141X
No coin nor oath required. For personal study only.
✦ Synopsis
This tutorial presents a practical approach to implementing computer validation across a whole laboratory organization. It discusses the types of policies and practices which need to exist in order to meet both business and regulatory needs in the multi-system, multi-department laboratory workplace. It advocates the use of international standards (IEEE, ISO) and global regulations (GLP, GCP, GMP, CANDA) for validation activities and documentation. Experience has shown the approach to be useful in many companies and in many countries.