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November 2010

Jennifer Stepniowski

Four Common Quality Misconceptions

by Jennifer Stepniowski
Special Project Manager, Pro QC International

For over a decade now, I've had the distinct pleasure of talking quality with professionals representing a myriad of industries. For the most part, people who reach me are experiencing a quality related issue and are looking to quickly extinguish the fire and prevent recurrences. Or, they may simply want to reduce their overall risks--and costs--by incorporating a specific quality initiative.

Every situation is unique, so it's important to be as knowledgeable as possible regarding the company I'm working with and their respective industry. Whether it's a small business owner, a QA Manager, or a CEO of a large corporation, these initial conversations allow me to customize an action plan that will address the client's needs and concerns.

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Dr. George L. Harris

19 Key Elements to Review for Effective Audits

by Dr. George L. Harris
DBA, CPM, CPCM, President, Calyptus Group

Regulated organizations on a global scale have instituted ways of qualifying suppliers to ensure that their capabilities have been verified. The types of qualification methods used are multifold. Some include quality and business system components that are essential for effective production or service rendering. Others may simply focus on quality characteristics, and still others may only consider production and equipment capabilities. More effective methods, however, include a combination of business, production, service, and quality factors to provide a holistic impression of the supplier's organization. These factors play a critical role in providing excellent customer service.

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Do you know what 'readily available' means in the context of 21 CFR Part 11 documentation? If you're familiar with 21 CFR Part 11 documentation you may have wondered what "ready available" means. Or perhaps you've also wondered what "instantly" refers to in the same context. According to Labcompliance News, it's these phrases that keep regulated companies guessing.
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