Pilgrim Quality Solutions Posts

Supplier Quality Management in the Medical Device Industry

Supplier Quality Management in the Medical Device Industry

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

When I recapped the first webinar in Pilgrim Quality Solutions’ Quality In, Quality Out: Supplier Quality Management four-part series, I started my blog with two questions:

  • Do you have the proper process 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?

(more…)

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…)

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…)

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 a quality management system, the best advice is inclusion.

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

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…)

Risk-based CAPA and the Drive for Continuous Improvement

Risk-based CAPA and the Drive for Continuous Improvement

Joshua Centner, Industry Solutions Group Manager, Pilgrim Quality Solutions, an IQVIA company

No matter the industry, if you are a member of a Quality Affairs team, you know that a Corrective and Preventive Action (CAPA) system provides a wealth of information regarding the quality of your organization’s products and processes. However, few companies fully leverage the power of this tool to realize its positive impact to the bottom line.

For instance, it is commonplace for a CAPA to be initiated for each nonconformance or deviation, or product quality-related complaint or audit finding, regardless of scope or severity. Despite intense regulatory pressures, though, not every one of these circumstances should necessarily trigger a CAPA. The “everything is a CAPA” syndrome is both costly and time consuming. (more…)

Risk-based Audits: 5 Steps to Taking the “Risky” out and Putting the “Quality” in Your Business

Risk-based Audits: 5 Steps to Taking the “Risky” out and Putting the “Quality” in Your Business

Phil Johnson, Senior Director, Quality & Compliance Services, IQVIA

If you’re responsible for planning and carrying out your company’s internal audits, you know how much planning and effort it takes to monitor your quality system for GMP and ISO compliance. As your quality system has matured, you’ve probably noticed that certain sites, departments, or processes require more of your attention, while others are consistently in compliance and don’t need as much assistance. If this is the case in your organization, it’s time for you to consider a risk-based approach to your internal quality system audits.

The Value of a Risk-based Approach

A quality risk-based approach to internal audits allows you to assess the importance and performance of each area to be audited, and to use your results to devote your auditing time and resources to these critical business areas. Based on this risk assessment, you may also decide that certain areas of your business don’t need as much oversight. (more…)

ISO 13485 Compliance: Embed Risk Management within your Supplier Inspection Process

ISO 13485 Compliance: Embed Risk Management within your Supplier Inspection Process

Kavitha Rajaram, Senior Software Development Analyst, Pilgrim Quality Solutions, an IQVIA company

With deadlines approaching, ISO 13485 compliance is becoming more critical than ever before. Additionally, since ISO 13485 will be used as an auditing standard for the Medical Device Single Audit Program (MDSAP), your company may need to adhere to these standards during a regulatory audit. If you haven’t signed up for MDSAP audits yet, to prepare, you should conduct a gap analysis that closely examines organizational processes, especially quality management.

One of the prime high-risk areas in any manufacturing enterprise is its supply chain. A solid Supplier Quality Management system will support the processes that enhance supplier quality and keep supplier risk under control, improving the enterprise’s overall quality and compliance. (more…)