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 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…)

EU GDPR: Are You Ready? Is Your Quality Management System, Too?

EU GDPR: Are You Ready? Is Your Quality Management System, Too?

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

EU GDPR — The Week is Here!

The General Data Protection Regulation (GDPR), approved by the European Parliament and Council in April 2016, replaces the Data Protection Directive 95/46/ec at the end of this week, on May 25, 2018. It will become the primary regulation protecting all European Union (EU) data subjects from privacy and data breaches in a world driven by data — a world very different from the time in which the 1995 directive was established. (more…)

Florida Medical Manufacturers Consortium: 2018 Symposium Update

Florida Medical Manufacturers Consortium: 2018 Symposium Update

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

Established in 2003, the Florida Medical Manufacturers Consortium (FMMC) strives to unite, promote, and grow Florida’s Medical Device Industry and enhance the business success of its member companies. To that end, every year the Consortium hosts a Symposium to allow for industry networking, the expansion and sharing of industry knowledge and expertise, and to update its members on advocacy activities.

FMMC’s current advocacy activities occurring at the state and national level include:

  • Supporting Florida legislation fully exempting the purchase of manufacturing equipment (MME) from sales tax
  • Backing proposed legislation to reduce Florida’s sales tax on commercial rent
  • Working with national, regional, and industry advocacy groups in the fight to repeal the medical device excise tax

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