Strategic Planning for the EU Medical Devices Regulation: Have You Spoken to Your Notified Body Yet?

Strategic Planning for the EU Medical Devices Regulation: Have You Spoken to Your Notified Body Yet?

Caroline Freeman, Principal Consultant, Consulting Services, IQVIA
Phil Johnson, Senior Director, Quality & Compliance Services, IQVIA

We are now almost one-third of the way into the 3-year transition period for the EU Medical Devices Regulation (2017/745/EU) (MDR).

The MDR has significant economic impact on manufacturers — not just the cost of implementing the new regulations for new products, but ensuring legacy products meet the new requirements, as there is no grandfathering from the current EU Medical Devices Directive (MDD). The MDR has a big impact on distributors and importers, as well as manufacturers. This means that some distributors/importers (Economic Operators) of CE-marked products may cease their involvement under the MDR. The medical device supply chain is quite complex, often with involvement of multiple distributors, from manufacturers to patients. It is a global issue, as it affects all manufacturers/distributors that sell in to the EU.
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The Path to ISO 13485:2016 Compliance – What’s Your Next Step?

The Path to ISO 13485:2016 Compliance – What’s Your Next Step?

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

This industry continues to buzz about ISO 13485:2016. The February 28, 2019 deadline is now less than one year away, and many organizations need to take advantage of every minute between now and then to be compliance-ready. Plus, busy registrar schedules, combined with your company’s certificate expiration, mean that you may have less time to prepare than you think.

Pilgrim is here to help you along the path to compliance. Are you ready to move forward?
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Pilgrim Quality Solutions: 25 Years of Quality, Compliance, and Success

Pilgrim Quality Solutions: 25 Years of Quality, Compliance, and Success

Pilgrim Quality Solutions, an IQVIA company

This week, Pilgrim Quality Solutions proudly celebrates 25 years of commitment to helping hundreds of organizations around the globe manage product quality with confidence, enhance patient safety, and be more prepared for audits than ever before. Pilgrim has pioneered quality management software solutions since 1993, bringing industry best practices to the Life Sciences sector, and partnering with the world’s leading companies to enhance their quality processes, positively impact their financial performance, and achieve regulatory success.

In honor of this accomplishment, we look back over the last 25 years of events that have defined Pilgrim as the leading provider of enterprise quality and compliance management software and services for the Life Sciences and other highly regulated industries.
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Pick Up a New Habit: Making Quality a Priority

Pick Up a New Habit: Making Quality a Priority

Sandy Carson, Marketing Communications & Events Manager, Pilgrim Quality Solutions, an IQVIA company

“Quality isn’t an act, it’s a habit.”

Aristotle said it first. But it doesn’t take a philosopher or a scientist to recognize that excellence doesn’t happen overnight. Just ask the drum major in the local high school band or the prima ballerina in the regional ballet company. It takes ongoing commitment to reach the pinnacle and continuous approaches to quality improvement to remain there.

The QA director at a leading pharma or medical device company know this, too. Very well. The practice of continual improvement starts with a unified, enterprise-wide commitment to ongoing best efforts and to process improvement. (more…)

Who Moved My Cheese? Address, and Conquer, the “Change Barrier” for Enterprise Quality Management

Who Moved My Cheese? Address, and Conquer, the “Change Barrier” for Enterprise Quality Management

Brian Myers, Strategic Account Executive, Pilgrim Quality Solutions, an IQVIA company

The business case for quality is typically very strong, yet we still find projects mired in indecision and inaction. Spend enough time in the Quality and Compliance space working with regulated Life Sciences companies of varying size, organizational maturity, and product breadth, and you start to notice some striking similarities when it comes to reasons why really good enterprise Quality Management Systems (eQMS) projects stall or never even get started. The obvious answers are business priority, funding, and project resources. The more insidious reason is fear of, resistance to, or a complete lack of planning for an inevitable change.
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Validated Cloud Solution… absolutely!

Validated Cloud Solution… absolutely!

Ninoshka Ortiz, Senior Validation Specialist, Pilgrim Quality Solutions, an IQVIA company

Life Sciences organizations are progressively searching and shifting to cloud-hosted environments to increase efficiency and reduce costs. But to do so, those organizations must be able to select a cloud service provider that helps to assure the confidentiality, integrity, and availability of data stored in the cloud.

Cloud-hosted environments help Life Sciences organizations with validation challenges and ease the process of qualifying cloud infrastructure with emerging capabilities and tools. In addition to the methods and controls to support the achievement of continuous quality and regulatory compliance, these organizations are seeking ways to maintain their Quality Management Systems (QMS) in a secured and validated state.
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Real World Data and Evidence: Promise of Improved Patient Outcomes

Real World Data and Evidence: Promise of Improved Patient Outcomes

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

During the 12th Annual Conference for the Business of Biotech, held at the Moffitt Cancer Center in Tampa, Florida on March 2, 2018, it was no surprise that the theme of the conference was Discovering Tomorrow’s Cancer Cures. With the keynote on Immunotherapy and the impact it’s having on the treatment of cancer, as well as discussions on Adaptive Therapies, and breakthroughs made possible by the 21st Century Cures Act, one could feel the promise of recent and near-future advancements in the fight against cancer.

With all the science-based presentations at the conference, the session titled Real World Data: Mining Gold from a Mountain of Straw drew my attention. The session focused on Real World Data (RWD) and Real World Evidence (RWE), and how to draw insights from both to improve patient outcomes.
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Benchmark the State of Your QMS and Take On Quality’s Next-Gen

Benchmark the State of Your QMS and Take On Quality’s Next-Gen

Last week, we discussed the much-buzzed about topic of Next Generation Quality, commonly referred to as Quality 4.0. We posed the question: What does a Next-Generation Quality Management System (QMS) look like for a Life Sciences organization?

To capture a snapshot of the current QMS landscape, Pilgrim Quality Solutions recently conducted a market research study of quality and compliance professionals from the Top 2,000 Pharmaceutical, BioTech, Medical Device, and Combination Product companies on the “state of the state” of their current QMS capabilities and needs.
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Best Practices for Attaining Next Generation Quality

Best Practices for Attaining Next Generation Quality

Justin L. Smith, Director of Product Management, Pilgrim Quality Solutions, an IQVIA company

What does a Next-Generation Quality Management System (QMS) look like for a Life Sciences organization? In a recent market research study conducted for Pilgrim Quality Solutions, quality and compliance professionals from the Top 2,000 Pharmaceutical, BioTech, Medical Device, and Combination Product companies were surveyed on the “state of the state” of the business, regulatory, and technology landscape and their current QMS capabilities and needs.

This research provides fresh insights into the state of quality and compliance management in the Life Sciences industry, as well as quantitative data which demonstrates that many Life Sciences companies are preparing for or embracing Next-Generation Quality Management practices.
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Bridging the Gap to Quality 4.0

Bridging the Gap to Quality 4.0

Larry Ferrere, Senior Director of Business Marketing, Pilgrim Quality Solutions, an IQVIA company

It is still amazing to me the number of companies that are managing their quality and operating in SharePoint, Excel, and with paper-based SOPs and disparate systems. Thus, it shouldn’t surprise me, but it does, that so many companies do not know the level of their Quality Maturity or their Cost Of Quality. If they say they do know, they inevitably over-rate themselves as much more mature than the norm or where they truly are, and they understate their total Cost Of Quality.
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