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Insights

The Latest from Our Expert Consultants

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THE MOVE TO QUALITY 4.0: THE PROCESS STREAM PERSPECTIVE
We’re back in our Princeton, NJ Headquarters after an informative and enlightening week down in Orlando for Sparta Systems’ annual Sparta Connection TrckWise User Conference.
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What to Expect at Sparta Connection 2018
That time of the year has come again! We are in full prep-mode for the annual Sparta Connection Conference. Process Stream will have an expanded presence this year, and we are excited to reconnect..
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QUALITY SYSTEM VALIDATION AS A JOINT VENTURE BETWEEN INTERNAL RESOURCES AND EXTERNAL EXPERTS
UPDATES, MERGERS, ACQUISITIONS, OH, MY! Unless your Company is a startup, you already have an established Quality System in place.  So for most, Quality System improvement is an ongoing challenge. ..
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ARE YOU PLANNING PROPERLY FOR YOUR SYSTEM’S VALIDATION? KEY QUESTIONS TO ASK YOURSELF BEFORE, DURING AND AFTER A SYSTEM IMPLEMENTATION
When implementing a software system, the decisions made during the planning process impact the future for the lifetime of the system.  With a heavy emphasis on the software selection, installation..
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AS OUR WORLD GETS MORE DIGITAL, YOUR SPREADSHEET BASED QUALITY PROCESSES NEED TO ADJUST
In today’s society, with the almost countless number of software applications for quality systems, it’s foolish for any company serious about regulatory compliance and achieving quality within their..
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3 Tips for an Effective Quality Management System (QMS) Training Program
Many Life Science and Medical Device organizations struggle with how to align training compliance with business strategy, resulting in reactive and often overwhelming training without any real value,..
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How to Optimize Your Investment in EQMS: Facilitate Clear Communication Between Systems and People
Industry information from service providers dictates that an EQMS is so vital to an organization’s optimal performance, that increased attention to fine-tuning quality ecosystems is directly related..
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Who Determines the Standard of Quality?
The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments. 
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