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Featured Articles

July 2010

Lisa Walters

Stop the Process Control Madness!

Lisa M. Walters
Ph.D., Principal Officer of Healthy Solutions, Quality Consulting, LLC

It is a dark and stormy night. Your facility is readying for what promises to be a challenging third-party review. You, the Quality Manager, along with your organization's General Manager, are reviewing a variety of the process monitoring data reports to prepare for the upcoming "grilling." One such report provides information regarding response times to the central monitoring alarm system, specifically for the reagent storage refrigerator. Your GM asks you why this response time is being monitored. You remind her that this was an issue in the past, and you are continuing to monitor to evaluate the effectiveness of the implemented corrective action. The GM continues to study the report. The GM is not so delighted. She wants those response times shortened, and she wants the results now! What's a Quality Manager to do?

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Jason Clegg

Nonconformance Management: FDA & ISO Compliance

Jason Clegg
Marketing Director, MasterControl, Inc.

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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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 a recent proposal suggests a rule that would disqualify a life science clinical investigator from working on clinical investigations associated with life science fields such as biologics, pharmaceuticals or medical devices? The rule is designed to protect the subjects of clinical research across the various fields regulated by the FDA. The rule would also allow the FDA to harmonize investigator disqualification regulations across the board.
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