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The Latest from Our Expert Consultants

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LOOK ABOVE AND BEYOND THE IMPLEMENTATION: THE IMPORTANCE OF HYPERCARE AND ONGOING SUPPORT
/ Rahul Bhatia
IT professionals within the Life Sciences industry traditionally characterize successful engagements as relying on solid planning and a strong implementation.  The completion of the development and..
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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
/ Rahul Bhatia
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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Transform Selection Value Management Through Advanced Tools and Automation
A Simple Solution for Complex Organizations In our conversations with IT Executives within the Quality Management space, leaders want quick returns on their investments that complement and streamline..
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What 2018 and the FDA Have in Store for Electronic Medical Device Reporting (eMDR) Submissions
Life Science companies that manufacture medical devices need to stay on the forefront of compliance with the latest regulatory requirements. Recently, the FDA laid out updated requirements for..
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4 Signs it's Time to Standardize Your Quality Management System
Global organizations are increasingly grasping the power behind data and process streamlining; the benefits will pave the way for growing a culture of quality and compliance. Becoming a mature,..
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Making the Move: How to Transfer Your QMS to a Cloud Solution
/ Mickey Huber
For years we’ve heard about the benefits of moving to the cloud. Lower costs, staying current with the latest technology, and scalability as your company grows certainly give you a competitive..
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3 Tips for an Effective Quality Management System (QMS) Training Program
/ Henry Mossi
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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Change Management: How Project Managers Can Effectively Manage Change
/ Shameica Woollery
Project managers play such an important role in an organization’s ongoing projects and implementations, and especially now more than ever before. Senior execs typically rely on their PM’s to be the..
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