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Practical computer validation for pharmaceutical laboratories

โœ Scribed by R.D. McDowall

Publisher
Elsevier Science
Year
1995
Tongue
English
Weight
862 KB
Volume
14
Category
Article
ISSN
0731-7085

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โœฆ Synopsis

Computer validation should address the scientific correctness of the application software, the business objectives of the organisation, and the concerns of regulatory agencies. It is a balance between a practical and cost effective system that must develop the confidence that the system is under control. This paper gives an overview of computer validation from the following perspectives. What is computer validation? Why can a computer system not be completely validated? Why and how should computer systems be validated? The principles outlined in this paper should be adapted to a specific system on a case by case basis depending on its scope and complexity.

๐Ÿ“œ SIMILAR VOLUMES

A practical approach to method validatio
A practical approach to method validation in pharmaceutical analysis
โœ G.P. Carr; J.C. Wahlich ๐Ÿ“‚ Article ๐Ÿ“… 1990 ๐Ÿ› Elsevier Science ๐ŸŒ English โš– 396 KB

Guidelines issued by Regulatory Authorities make it clear that validation of analytical methodology is now widely required in support of registration dossiers. Although some attempts are made at defining terms and some vague indications are sometimes provided within these guidelines, no clear advice