PMO Methodologies: An Exploratory on Project Planning and 'Getting Across the Finish Line'

Mar 29, 2018/ Shameica Woollery

With the growth of computer system and application development and its use, Project Management, as a discipline, has grown leaps and bounds over the past decade or so, particularly in the area of..

Management Strategies Series - Volume 1: Dealing with Unplanned Demand in Your Quality Ecosystem

Mar 19, 2018/ Rahul Bhatia

Demand related to resource management is a perpetually evolving piece of our profession. There is a constant re-prioritization of efforts that can have profound impact on our business and bottom..

LOOK ABOVE AND BEYOND THE IMPLEMENTATION: THE IMPORTANCE OF HYPERCARE AND ONGOING SUPPORT

Feb 1, 2018/ 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..

QUALITY SYSTEM VALIDATION AS A JOINT VENTURE BETWEEN INTERNAL RESOURCES AND EXTERNAL EXPERTS

Jan 19, 2018/ Nancy Gleason and Mariam Mirza

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. ..

ARE YOU PLANNING PROPERLY FOR YOUR SYSTEM’S VALIDATION? KEY QUESTIONS TO ASK YOURSELF BEFORE, DURING AND AFTER A SYSTEM IMPLEMENTATION

Jan 11, 2018/ Nancy Gleason and Rahul Bhatia

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..

AS OUR WORLD GETS MORE DIGITAL, YOUR SPREADSHEET BASED QUALITY PROCESSES NEED TO ADJUST

Jan 10, 2018/ 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..

Transform Selection Value Management Through Advanced Tools and Automation

Nov 30, 2017/ Dave Desiderio and May Mak

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..

What 2018 and the FDA Have in Store for Electronic Medical Device Reporting (eMDR) Submissions

Nov 28, 2017/ Mickey Huber and Geoff Smith

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..

4 Signs it's Time to Standardize Your Quality Management System

Nov 7, 2017/ Jason Voss and Rahul Bhatia

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,..

Making the Move: How to Transfer Your QMS to a Cloud Solution

Sep 28, 2017/ 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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