2016 Posts

Happy Holidays from the Pilgrim Quality Blog Team

Happy Holidays from the Pilgrim Quality Blog Team

It has been our pleasure this year to share with you our perspectives on the latest topics in the Quality & Compliance industry. We wish you a delightful holiday season and a prosperous 2017.

Best Wishes,
Pilgrim Quality Solutions

Quality Management Systems: More than the Company Historian

Quality Management Systems: More than the Company Historian

Kari Miller, Vice President of Regulatory & Product Management, Pilgrim Quality Solutions

Product Quality is a given in Life Sciences organizations; after all, the purpose of producing a medical device or pharmaceutical is to improve the life of the patient using the product. The backbone to producing quality goods is a Quality Management System (QMS) that, by definition, supports the processes focused on consistently meeting customer requirements and enhancing customer satisfaction.

In a global industry environment that is constantly evolving, it has become apparent that a new approach will be required if organizations are to achieve the goal implicit in that definition. The Quality Management System will need to simultaneously evolve beyond the role of company historian and expand its primary focus of achieving compliance. Quality data needs to be turned into information that is informed, actionable, proactive, and predictive. In other words, information that truly fosters a culture of quality.
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Evaluating the Cost of Quality: It’s Simple Math

Evaluating the Cost of Quality: It’s Simple Math

Deborah Kacera, Regulatory & Industry Strategist, Pilgrim Quality Solutions

Every regulated organization understands the need to implement a quality system. In fact, it’s a “shall” clause for all Life Science companies to ensure they are in compliance with industry regulations.

The focus of any effective quality system is, and rightly so, all about ensuring Patient Safety. From there, as the organization matures, its people, processes and technology evolve from a compliance, to a correction, to a prevention mindset, eventually resulting in increased quality brand recognition and shareholder value.
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CGMP and ISO 13485: Aligning Device Quality Worldwide

CGMP and ISO 13485: Aligning Device Quality Worldwide

Kari Miller, Vice President of Regulatory and Product Management, Pilgrim Quality Solutions

Regulators around the world commonly assess product design to ensure safety and efficacy in medical devices. The product approval process is key to ensuring the safety and efficacy of life-improving and life-saving products introduced into their market. However, oversight does not stop there. Worldwide, regulatory bodies are looking to ensure sustainability; they need to “see” that an organization can continuously produce and provide safe, quality product to their market. How do they do that? By auditing an organization’s quality system.
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Key Takeaways from This Week’s ISO 13485:2016 Knowledge Exchange

Key Takeaways from This Week’s ISO 13485:2016 Knowledge Exchange

Deb Kacera, Regulatory and Industry Strategist, Pilgrim Quality Solutions

Earlier this week, we hosted a webinar titled “ISO 13485:2016 – Will Your Transition Be a Marathon or a Sprint?” This webinar is the first in a series of four webinars that Pilgrim will be hosting to support medical device organizations during the transition to ISO 13485:2016.

In the webinar, Dan O’Leary, President of OMBU Enterprises, presented an overview of changes to the standard, as well as a deeper dive into the areas of Risk, Design Control, Supplier Management, and CAPA. The presentation provided additional insights that went beyond the standard to help everyone who attended get a handle on the scope of their transition.
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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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Insights on Out of Specification Management and Compliance

Insights on Out of Specification Management and Compliance

Kevin Lee, Industry Solutions Consultant, Pilgrim Quality Solutions

This week, Pilgrim is officially introducing a new fully-validated solution called SmartSolve® Out Of Specification Management. Managing out-of-specification (OOS) results is a critical area of focus among pharmaceutical and combination product manufacturers. To help you understand the critical nature of this operational element, we’ve created this Q&A about compliance facts and insights on data integrity, and commonly used acronyms that relate to OOS. Let’s begin with the basics. (more…)