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Featured Articles

July - September 2010

Brian Curran

Automating Training Control Processes for Compliance

Brian Curran
SVP, Strategic Marketing & Product Management, MasterControl, Inc.

FDA regulatory requirements and ISO quality standards mandate companies to execute and document employee training (21 CFR 211.25 and 820.25). These requirements ensure employees understand how to perform their duties within company and industry guidelines. Well-managed training programs minimize the risk of non-compliance and improve product quality. This article identifies the basis for the requirements and examines the associated challenges for meeting those requirements. In addition, this article discusses the shortcomings that lead to general system failures. A new approach for meeting and going beyond the tracking of requirements is presented.

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Mark Kaganov

ISO 9001: Quality Objectives and Quality Dreams

Mark Kaganov
Director of Quality Operations, Quality Works

This article reviews common practices for, and the positive results of, establishing measurable quality objectives for ISO 9001 and other quality management systems. Kaganov, the Director of Quality Operations at Quality Works, suggests a practical model for identifying and documenting objectives to drive the continual improvement of management systems. The ineffectiveness that results from vague and poorly defined quality objectives will be demonstrated; it will also be shown that well-structured and documented quality objectives can lead to a more efficient quality management system that increases customer satisfaction. An example of a Quality Objectives Matrix (shown in the article) presents a useful method for documenting and managing various aspects of quality management systems.

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Quality Basics Simplify Complex Engineering Document Management Challenge

In the spring of 2006, Ray Wilson, an internal business systems analyst for an investor-owned utility company, faced a monumental challenge: how to go about transferring the management of approximately 750,000 documents on paper, Mylar, microfiche, and other media from more than 150 different facilities to one centralized location.

Although the scope may have been once-in-a-lifetime, at the heart of the task was a common problem for engineers everywhere: content management for engineering drawings.

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Did you know that MasterControl can streamline the control of your company's documentation and training processes? With MasterControl users gain the ability to collaborate from virtually anywhere, to protect all forms of documentation (any file type), maintain document securities by user, save time with version control and hard-copy control methods.
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