August 2017 Posts

Compliance, Brexit, and EU MDR – A UK Perspective

Compliance, Brexit, and EU MDR – A UK Perspective

Cynthia Lambert, Regulatory Specialist, Pilgrim Quality Solutions

In 2016, the United Kingdom surprised the world following a referendum whereby British citizens voted to exit the European Union (EU). While news of the historic event, commonly known as “Brexit,” an abbreviation for “British exit,” took many, both inside and outside the U.K., by surprise, its potential impact has global commerce and industry actively formulating strategies to minimize or avoid any resulting disruptions.
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Deploying QMS – Have it Your Way Now and in the Future

Deploying QMS – Have it Your Way Now and in the Future

Sandy Carson, Marketing Communications Manager, Pilgrim Quality Solutions

Can you predict, with certainty, how your company’s management and IT services will choose to evolve its business and its quality management solution model over the next few years? How about over the next decade? Unless you’re a soothsayer, it would be wise to adopt a platform solution today with enough flexibility to meet whatever needs and whatever challenges tomorrow may bring.
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Process-based Versus Records-based Quality Systems – Which is the Key to EQMS Success?

Process-based Versus Records-based Quality Systems – Which is the Key to EQMS Success?

Joshua Centner, Industry Solutions Manager, Pilgrim Quality Solutions

As an Industry Solutions Consultant, I interact with clients who are evaluating the features and functions of various Enterprise Quality Management Systems (EQMS). It seems there is one major factor which is overlooked time and time again. It pertains to the overall design of the EQMS, and will impact the long-term value of the solution to an organization. This critical element is whether the EQMS is a records-based system or a process-based system.
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The Supplier Qualification Framework – Assessment, Responsibility, and Control

The Supplier Qualification Framework – Assessment, Responsibility, and Control

Florian Czaszewicz, Industry Solutions Consultant, Pilgrim Quality Solutions

Last week, I had the opportunity to explore the Life Sciences Supplier Qualification and Control Framework along with Nicky Dodsworth of Premier Research, Dr. Benjamin del Tito of the Biologics Consulting Group, Peggy J. Barry of Synergy Consulting, and The Knowledge Group. In today’s post, we’ll review key takeaways from Pilgrim’s portion of the webinar. If you’d like to view the entire webinar, you can watch the on-demand version of Life Sciences Supplier and Contractor Qualification and Control Framework Explored here.
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