Poorly developed software could have ten times as many defects as well engineered software. As with other products, quality has to be built in. If the software is of poor quality, validation testing is not going to make it function properly. This checklist is a form for conducting an on-site audit of a software vendor's quality system, and software development and support processes. It can be used to determine if the vendor has built the software you intend to purchase with the software development practices associated with quality software and recommended in the FDA guidance document on computer system validation. 44 pages
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The purpose of this work instruction is to provide an audit checklist for auditing computer system software as recommended in VAL007.
This work instruction applies to the audit of both commercial and custom software developers.
The auditor is responsible for completing the checklist based on the audit that is conducted.
The depth of auditing ought to depend on the risk associated with the system.
