October 2016 Posts

The Case for Quality System Transformation

The Case for Quality System Transformation

Kari Miller, VP of Regulatory and Product Management, Pilgrim Quality Solutions

Recently, Pilgrim was a sponsor and a presenter at the American Medical Device Summit. The conference examined the challenges and opportunities currently facing the medical device industry. It also focused on the journey to best practices in the area of design, quality, compliance, technology, and strategy.

The quality track examined the value of creating an environment conducive to building a quality culture, with change management, harmonization, and collaboration as central themes. In fact, collaboration was a key theme throughout the conference as an element of innovation, risk management, sustainability, and compliance.
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MDSAP is Flying on Auto Pilot through 2016

MDSAP is Flying on Auto Pilot through 2016

Sandy Carson, Marketing Communications & Events Manager, Pilgrim Quality Solutions

In 2012, the International Medical Device Regulators Forum (IMDRF) identified a work group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP). Forum members agreed that this global approach to auditing and monitoring medical device manufacturing could improve product safety and oversight on an international scale.
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Vendor Data Privacy and Security Due Diligence – Don’t be “That Guy”

Vendor Data Privacy and Security Due Diligence – Don’t be “That Guy”

Lesa-Marie Mullen, Senior Legal Counsel, Pilgrim Quality Solutions

Maybe it’s a budget deadline. A price expiring. An important project timeline. The vendor is selected, the lawyers have finished dotting the I’s and crossing the T’s, and the pens are poised to ink the partnership into existence. Suddenly someone shouts, “But we need to do our data privacy and security due diligence!”
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Best Practices in Change Control: Taming the Winds of Change

Best Practices in Change Control: Taming the Winds of Change

Sandy Carson, Marketing Communications Manager, Pilgrim Quality Solutions

We witness the impact of Change Control every day, in the most mundane places. For instance, take a trip down the grocery store aisle and you’ll quickly see packages and cans boasting “New and Improved Formula” for everything from soup to soap. It seems that manufacturers are constantly improving their products. But are they really better…or just different?
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