Quality Control: the Punch and Pizazz of Compliance Software and the Internal Audit

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More from Marci Lynn Crane

Electronic Regulatory Compliance Training: a Combined Solution for the Life Science Industries
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Regulatory compliance training can be accomplished by in-house manual processes or by agency staffers. Life science companies seem divided between the two options but perhaps that is only because a third option remains slightly less obvious.

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What is the foundation for GxP compliance? What is the solution for electronic GLP training? Will compliance regulations and life science companies ever find a middle ground process?

A Summary of Glp Training Regulation Requirements in 21 Cfr Part 58: Associated Complications and Solutions
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GLP training regulations indirectly require substantial amounts of time and revenue for nonclinical research entities to obtain compliance. However, nonclinical research facilities can save time and significant revenue by recognizing both the complications and solutions associated with GLP training management.

Why a Six Sigma Based Quality System May be the Answer for Pharmaceutical Companies
By: Marci Lynn Crane | 19/02/2008 | Management
For pharmaceutical companies, sometimes the FDA’s GxPs might seem like enough quality system management to keep everyone busy. Additionally implementing Six Sigma principles however might be the “perfect quality match” for quality system management in the pharmaceutical industry.

5 Reasons Medical Device Companies Should Automate Their Quality Systems
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Medical device companies can benefit NOW from the automation of their compliance management and quality systems.

Streamlining Clia Compliance With Software: a Call for Lab Professionals to Return to Science
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Paper and hybrid solutions are the mainstay of CLIA regulated clinical laboratory quality systems. They admittedly result in a myriad of faux pas but why spend money on another technological solution if it isn’t going to do what it was “designed” to do? This article presents the characteristics of real (and relatively simple) CLIA streamlining technology.

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Change control software---if desired---should provide speed, simplicity and conformance with important change control purposes.

A Revolution and a New Habit in Quality System Process Management for Pharmaceutical Companies
By: Marci Lynn Crane | 05/01/2008 | Technology
Life science companies, especially pharmaceutical gains stand to increase their workable ROI by millions of dollars with the quality system technology that controls documentation, automatically provides reportable audit trails, and connects people and quality processes more effectively.