Auditing strategies, old versus new

✍ Scribed by Anders Wichman

• Book ID: 102660252
• Publisher: John Wiley and Sons
• Year: 1998
• Tongue: English
• Weight: 563 KB
• Volume: 3
• Category: Article
• ISSN: 1087-8378
• DOI: 10.1002/(sici)1099-1786(199803)3:1<21::aid-qaj54>3.0.co;2-g

✦ Synopsis

Auditing Strategies, Old Versus New

Auditing is an important part in establishing whether work is performed in compliance or not with Good Laboratory Practice (GLP). It is essential to understand the GLP and that it is a quality standard for laboratory work. There is no contradiction between GLP and good science. Auditing, according to the revised OECD GLP Principles of 1997, identifies three types of audits, study, process and facility audits. The work is usually described in processes. All of them consist of systems. Auditing should be concentrated on the systems. If they work properly then the processes and studies will be in compliance. System audits will, together with the other types of audits, give the whole picture.