Qualification and validation of software and computer systems in laboratories |
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Authors: | L Huber |
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Institution: | (1) Hewlett-Packard Waldbronn, P.O. Box 1280, D-76337 Waldbronn, Germany Tel.: +49-7243-602 209 Fax: +49-7802-981948 e-mail: Ludwig_Huber@hp.com, DE |
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Abstract: | When software and computer systems are purchased from vendors, the user is still responsible for the overall validation.
Because the development validation can only be done by the developers, the user can delegate this part to the vendor. The
user's firm should have a vendor qualification program in place to check for this. The type of qualification depends very
much on the type and complexity of software and can go from documented evidence of ISO 9001 or equivalent certification for
off-the-shelf products to direct audit for software that has been developed on a contract basis. Using a variety of practical
examples, the article will help to find the optimal qualification procedure.
Received: 8 August 1997 · Accepted: 12 September 1997 |
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Keywords: | Key words Validation Qualification Vendors Computers Analytical laboratories |
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