Extending Quality Management Beyond the Four Walls of Your Quality Organization

Extending Quality Management Beyond the Four Walls of Your Quality Organization

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

Let’s face it, the arms of regulators are getting longer and so is their vision. The extended supply chain is experiencing additional oversight by regulatory bodies around the world, and in fact, your suppliers’ suppliers are not immune to that scrutiny. The list of organizational quality stakeholders continues to grow as the value chain expands to include suppliers and even regulators themselves.

This means that a Quality Management System (QMS) needs to be enterprise strong and it needs to be global if an organization is to respond to harmonization of standards, guidelines, and regulations around the world regarding the organization’s value chain.
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17 Quality, Compliance, and Risk Management Resolutions for 2017

17 Quality, Compliance, and Risk Management Resolutions for 2017

A new year has begun. For most of us that means a fresh start and a brand new set of goals. But have you set your quality and compliance goals and resolutions for 2017? Whether you’re just getting started or planning the next steps in your quality maturity, Pilgrim’s quality and compliance experts are here to help you start the year off right.

In today’s post, we’ve asked our experts, “As a quality and compliance professional, what is your top resolution for 2017?” Here are some ideas that will lead you and your organization to a happy and prosperous new year.
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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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Automated Computer System Validation: The Key to Increasing Your Quality System’s Efficiency

Automated Computer System Validation: The Key to Increasing Your Quality System’s Efficiency

Justin L. Smith, Manager of Product Management, Pilgrim Quality Solutions

Within regulated environments, such as the Life Sciences community, there are a number of top-of-mind business challenges. Key among them is to increase operational efficiencies while keeping pace with an ever-evolving regulatory landscape. A daunting challenge to say the least, mainly due to the “ever-evolving” factor.

To address the challenge, companies invest in fantastic new systems and software that provide the foundation for compliance while also affording significant efficiencies over their paper or manual processes. However, too often, companies get stuck on their initial version of software due to the cumbersome impact that computer system validation has on the upgrade process.
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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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ISO 13485:2016 Compliance: Resources to Help You Get Started

ISO 13485:2016 Compliance: Resources to Help You Get Started

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions
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Transitioning to ISO 13485:2016 compliance is the top priority throughout the medical device industry right now. The industry is buzzing with information on the latest version of the standard. Do you have a plan in place for getting your organization up-and-running with ISO 13485:2016? These resources will help you develop, fine tune, and implement your transition plan.
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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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