Quality In, Quality Out: Exploring Supplier Quality Management – Key Takeaways

Quality In, Quality Out: Exploring Supplier Quality Management – Key Takeaways

Daryl Oldham, Product Marketing Manager, Pilgrim Quality Solutions, an IQVIA company

Do you have the proper processes in place to evaluate, monitor, track, and rate your suppliers? How confident are you that you can rely on your suppliers, or even that you are protected from issues your suppliers encounter at any of their locations?

As global outsourcing activities increase, manufacturers should be placing additional emphasis on the control/oversight of their suppliers, and paying attention to potential risks. Poor cost of quality results in rework, waste, delays in product approval, resource inefficiencies, corrections and removals, enforcement actions, etc., which impact the bottom line. (more…)

Extended Supply Chains Require Enterprise QMS that Extends Outside your Four Walls

Extended Supply Chains Require Enterprise QMS that Extends Outside your Four Walls

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

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. Regulators will continue to focus in this area as data shows that scrutiny is warranted. For example, from the FDA for Medical Devices (just a portion of the life science market), 24% of all observations made in the period ending September 30th, 2017, were due to supplier issues. (more…)

Quality Nirvana Revisited

Quality Nirvana Revisited

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

With the pace at which business moves today, we’re not often provided the opportunity to revisit previous blog posts, reflect back on position statements, or re-examine our thoughts from a fresh perspective. However, recently an e-book that I authored two years ago, Finding Your Path to Quality Nirvana, was re-published, giving me the opportunity to reassess some of the questions that were posed within its pages.

In the e-book, I answered the following questions, and I wondered, now that time has passed, what came to be, and how some of the questions would be answered today. (more…)

Operational and IT Challenges to Effective Supplier Management

Operational and IT Challenges to Effective Supplier Management

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

Supply chain complexity has grown from simple domestic sourcing, manufacturing and distribution, to a complex evolution of global sourcing, manufacturing and distribution centers. Maintaining control of your entire supply chain is monumental and maintaining compliance is absolutely essential. If your organization hasn’t already implemented an automated Supplier Management system, you are undoubtedly feeling overwhelmed.

Technology is critical to securing the global supply chain because it is the only way to have visibility into products and assets across the extended supply networks, and the ability to immediately take action. (more…)

Simplifying Today’s Regulatory and Compliance Complexities

Simplifying Today’s Regulatory and Compliance Complexities

Bill Buzzeo, General Manager, U.S. Center of Compliance Excellence, IQVIA

The quality, regulatory, safety, and commercial compliance management areas are quite often looked at as organizational necessities rather than value-added functions. They also are areas that sometimes lack innovation and transformation.

In a recent global survey of pharmaceutical CEOs, regulatory concerns continue to be viewed as a threat to growth. In fact, since 2013, these concerns, collectively, are among the top three threats as reported by pharma executives (PWC’s 20th Annual Global Pharma CEO Survey). (more…)

Heralding the Era of Human Data Science

Heralding the Era of Human Data Science

Marla Kessler, Senior Vice President, Strategy, Marketing, and Communications, IQVIA

It’s an exciting time in healthcare. We now live in a world of bionic eyes and pills made from 3D printing. We are seeing technology advance health every day providing a glimpse of the potential ahead of us. Sharing this vision, we at IQVIA are exploring a new discipline – Human Data Science – to bring together the advances in data science with the possibilities of human science to improve health. (more…)

Make the Move: Solutions for Next-Generation QMS

Make the Move: Solutions for Next-Generation QMS

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

More than ever before, Life Science quality professionals are feeling the pressure of increasing regulations and the rapid pace of business and industry-driven change. In previous posts, we’ve discussed these challenges, as well as the imperatives for the next generation of quality solutions that will help meet them. Next-generation enterprise quality management systems (QMS) must drive real product quality, link closely with business objectives, enable global harmonization, support enterprise quality, and enable an organization’s culture of quality. That’s a tall order for most quality systems that are deployed within Life Sciences organizations today.
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Monitoring Supplier Performance Throughout the Product Lifecycle

Monitoring Supplier Performance Throughout the Product Lifecycle

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

Knowing your suppliers is as important as knowing the resources themselves. If you have a product defect, it doesn’t matter if it was a supplier’s fault or your own – the only thing the public will see and react to is your product and brand. And the latest regulations are putting more emphasis on the fact that you are responsible for the quality of your overall supply chain. It pays to keep a tight control on supplier management.

The first step in understanding suppliers is through an evaluation and acceptance process. What are their business systems? Are they financially stable? What does Dunn & Bradstreet have to say about them? What percent of their sales is the product or resource you need? If it’s not substantial, will that affect the quality? (more…)

Global Supplier Performance and the Regulations Driving Change

Global Supplier Performance and the Regulations Driving Change

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

Innovation within the Medical Device industry, and Life Sciences in general, continues to accelerate at an impressive clip with the introduction of groundbreaking new technologies, resulting in an increasing portfolio of medical devices. At the same time, the global healthcare industry is seeing explosive growth in the demand for those products almost as quickly as they hit the market.
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Gain Competitive Advantage through Risk-based Employee Training

Gain Competitive Advantage through Risk-based Employee Training

Lynn Willis, Partner Enablement and Training Manager, Pilgrim Quality Solutions, an IQVIA company

Being competitive takes skill. Remaining competitive takes continuous effort. It’s what every enterprise strives for, so organizations would do well to heed wise words from the father of business management, Peter Drucker: “The only sustainable competitive advantage is an organization’s ability to learn faster than the competition. Your organization may be getting a run for your money, quite literally, by not investing in a solid learning strategy.”

And when it comes to managing a life sciences organization’s product quality and corporate regulatory risk, wiser words have not been spoken. (more…)