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.
Similar content being viewed by others
Author information
Authors and Affiliations
Additional information
Received: 8 August 1997 · Accepted: 12 September 1997
Rights and permissions
About this article
Cite this article
Huber, L. Qualification and validation of software and computer systems in laboratories . Accred Qual Assur 3, 2–5 (1998). https://doi.org/10.1007/s007690050173
Issue Date:
DOI: https://doi.org/10.1007/s007690050173