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This paper articulates various issues with paper-based quality management systems based on research with quality management executives at mid-sized medical device companies.
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Revise your quality management program to be cost-efficient and proactive. This message couldn’t come at a better time.
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In recent years, the pharmaceutical industry has given greater priority and attention to quality assurance and regulatory compliance than ever before. With the FDA’s heightened focus on safety, regulatory agencies are increasing their presence in the manufacturing arena to ensure Current Good Manufacturing Practices cGMP.
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More than 50% of the Warning letters and Form 483s issued by the FDA are for CAPA violations.
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The FDA’s approach to enforcement and regulation is changing rapidly. The science associated with GMPs and product quality is also changing rapidly. Knowledge and education in these important areas must be at the highest levels.
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Compliance is a major focus area for Microsoft and the Office 2007 system.
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Onboarding "new hires" or moving employees from one assignment.
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Implementing Reusability and Knowledge Transformation
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Quality System Solutions Using SharePoint® & QualityLinks
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Especially for users of paper-based quality systems, it’s hard to believe that it’s been close to 25 years since companies first began using computers to facilitate their regulatory obligations for maintaining quality systems.
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