Laboratory software validation: can you prove it works?

✍ Scribed by M.J. Adams

• Publisher: Elsevier Science
• Year: 1995
• Tongue: English
• Weight: 53 KB
• Volume: 31
• Category: Article
• ISSN: 1381-141X
• DOI: 10.1016/1381-141x(95)80009-r

✦ Synopsis

There is now scarcely a procedure in the chemical laboratory which does not involve the use of computers at some stage. Concerns have built up over many years around possible errors and omissions in the process which eventually puts chemicals in the hands of the public. For many years industries which produce products for sensitive markets, notably the pharmaceutical and agrochemical industries, have accepted that their activities should be closely monitored and controlled. At the same time, many companies have accepted that it is in their own interest to demonstrate to their customers that their procedures are carefully developed and scrupulously controlled. In this atmosphere several schemes, such as Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Good Automated Laboratory Practice (GALP) and IS0 Guide 25 compete to provide the right regulatory framework.

Laboratory automation and information management

ELSEVIER

Laboratory Automation and Information Management 31 (1995) vii