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…)

Sample, Skip and Switch – The Basics of Risk-based Incoming Inspection

Sample, Skip and Switch – The Basics of Risk-based Incoming Inspection

Bernard Jee, Product Manager, Pilgrim Quality Solutions, an IQVIA company

You’re probably conducting incoming inspections today but if you aren’t taking a risk-based approach, chances are you’re performing inspections you don’t need to do and possibly overlooking the items which need to be inspected most.  Implementing a risk-based sampling system helps you spend less time and less money inspecting high-quality raw materials when you are already confident that they are good. You’re also able to pinpoint poorly performing raw materials and suppliers based on their inspection state. (more…)

Finding the Balance – Part 2: Where EU MDR and EU GDPR Intersect

Finding the Balance – Part 2: Where EU MDR and EU GDPR Intersect

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

The EU Medical Device Regulation (MDR), which went into effect in May 2017, is a complex and demanding regulation. In May of 2018, we were all introduced to the data protection requirements of the EU General Data Protection Regulation (GDPR). In the first part of this 2-part blog series, Finding the Balance, we examined key areas of EU MDR that need to be viewed through an EU GDPR lens. This second installment takes on the considerations of how organizations can comply with both regulations.

Every organization’s products and situation will be different, so offering a canned To Do list would not be effective. Each organization needs to work with its legal counsel and security group to determine the right approach for their organization. In Part 1, we outlined the three major categories of GDPR. It’s within these categories that EU MDR and EU GDPR intersect. (more…)

The Balancing Act between EU MDR and EU GDPR – Part 1 in a Series

The Balancing Act between EU MDR and EU GDPR – Part 1 in a Series

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

Meeting the reporting and legal requirements of regulations, such as the EU Medical Device Regulation (MDR) and the recently mandated EU General Data Protection Regulation (GDPR), can be a daunting task. An initial review of both regulations brings forth seemingly clashing requirements. In fact, the balancing act that needs to occur within an organization to comply with both is a delicate one.

This is the first of two blogs that will look at the components of EU MDR and EU GDPR. I will address the potential impact of EU GDPR on EU MDR, with a particular focus on Complaints processing and Vigilance and Safety Reporting. In part two, I’ll outline the areas where these two EU-based regulations intersect. (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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The Keys to Implementing an Inclusive Quality Management System

The Keys to Implementing an Inclusive Quality Management System

David Thomas, Sr. Director of Global Services, Pilgrim Quality Solutions, an IQVIA company

Frequently, I’m on the road speaking with customers and addressing quality professionals, and frequently I’m asked, “If you had to give one piece of advice to someone looking to implement an Enterprise Quality Management System (QMS), what would it be? When implementing an Enterprise QMS, the best advice is inclusion.

It’s one simple word – inclusion – but one loaded with such wide-ranging positive impact. (more…)