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Featured Articles

May 2010

How Auditing Supports Supply Chain Management

Dennis Arter

One of the fundamental rules of auditing is to measure and evaluate against requirements. While requirements come from multiple sources in an internal and registration audit, for supplier audits these requirements always come from the contract. (Contracts come in a number of different forms, such as purchase orders, letter agreements, etc.) Three things need to be considered, when writing a supplier contract: technical requirements, accept-reject criteria and/or management system requirements.

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Validation of Off-the-Shelf Software

David S. Brown

While there is extensive guidance and documentation available for the development and validation of proprietary software, there is relatively little guidance available for the validation of commercial off-the-shelf software (OTS). The FDA's guidance document for software development, while somewhat dated (2002), provides some general guidance (including reference to general principles of software development) and references to additional guidance documents for software used in production and processes.

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Quality Audit - A Tool for Continuous Improvement and Compliance

Jason Clegg

The word "audit," in the broadest sense, refers to a variety of activities. It may refer to an accounting firm examining the financial statements of a public corporation, or a consultant checking the process of lid sealant dispensing in a semiconductor package assembly line. It may even refer to a mystery shopper testing the patience of sales clerks in an upscale department store.

In this article, we'll systematically take a closer look at some things (e.g, financial statements, a factory process or even customer service) and discuss the results for purposes of evaluation and—ultimately—decision making.

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