Considerations to Ready your Organization for the Approaching EU MDR Deadline

Considerations to Ready your Organization for the Approaching EU MDR Deadline

IQVIA Quality Compliance

EU MDR readiness isn’t just a single activity – and is not isolated to a company’s activities in the EU. It requires changes to processes across your organization.

As you prep for the looming EU MDR 2020 compliance deadlines, are you ready? These previously published blogs provide insight into the components of the medical device product lifecycle, from concept to market, that you need to consider in assessing your organization’s preparedness for the May 2020 deadline. (more…)

The Psychology of Change: Optimizing your Technology Deployment

The Psychology of Change: Optimizing your Technology Deployment

Kari Miller, Regulatory and Product Management Leader, IQVIA Quality Compliance

When implementing enterprise software, whether a Regulatory Information Management (RIM) solution, Quality Management System (QMS) or an ERP system, the greatest predictor of its success will be how an organization manages the psychology of change. When an organization decides to implement new processes and/or new solutions, there are four phases of change that the organization is likely to experience: Denial (resistance), confusion, renewal and contentment. Hopefully the organization will experience all four phases if they are managing change properly. (more…)

Transform Your Approach to Compliance From Concept to Market

Transform Your Approach to Compliance From Concept to Market

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

Today’s drug and medical device manufacturers have several common challenges. First, nearly all are being impacted by the shifting global regulatory compliance environment as they simultaneously strive to stay ahead of the competition while safely and effectively meeting the needs of patients. Additionally, compliance has typically been seen as a department, not a shared responsibility, and collectively perceived as a cost center, not a value center. (more…)

Vetting Your Prospective Quality Vendor

Vetting Your Prospective Quality Vendor

IQVIA Quality Compliance

The capabilities of an enterprise Quality Management System (QMS) have been shown to provide significant competitive advantage among Life Sciences manufacturing and service organizations. The right company for your Quality Management System will facilitate the production of superior goods and services, while also continuously supporting regulatory compliance. That’s why the QMS vendor vetting process is a critical first step toward success.

We asked a cross-section of IQVIA Quality Compliance subject matter experts to share their perspective on the one question likely to draw the most insightful reply from a prospective vendor about how effectively that vendor will serve an organization. Consider these perspectives and think about how they might help you select a QMS vendor that will enable you to successfully attain your quality compliance goals. (more…)

Climbing the Quality Maturity Ladder

Climbing the Quality Maturity Ladder

Roxane Napoli, Associate Director – Product Marketing, IQVIA Quality Compliance

Life Sciences industry regulations are evolving rapidly, and many business leaders see these regulatory changes as a threat to growth. The pressure weighs most heavily on organizational quality compliance. But it is possible to lessen the load and address growth challenges by ascending the Quality Maturity ladder.

At any given time, a company’s maturity level falls within a range that scales from development (low quality maturity) to leadership (high maturity). The higher the stage of maturity, the quicker the realization of benefits: higher product quality, improved compliance and reduction in overall cost of quality. (more…)

Defining the Pharmaceutical Supply Chain: Start at the beginning

Defining the Pharmaceutical Supply Chain: Start at the beginning

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

The standard supply chain within the Pharmaceutical industry is complicated. It is subject to strict regulations and industry best practice standards. In addition to heavy oversight from regulators, industry, and consumers, the intricate structure of the Pharmaceutical supply chain, as well was its global nature, add to its complexity. The emergence of India and China, where there are now many excipient, API, and CMO suppliers, exemplify that global nature. This expansion on the global stage adds another serious layer of complexity. With distance, comes risk — the risk that something could go wrong not only in manufacturing, but in transit.

With so much at stake, a manufacturing organization must focus its vision from the very beginning. (more…)

Has Your QMS Had a Health Check-up Lately?

Has Your QMS Had a Health Check-up Lately?

IQVIA Quality Compliance

As the Life Sciences industry continues to experience an unprecedented level of change in regulatory requirements and oversight on a global scale, organizations worldwide are feeling ongoing pressure to demonstrate their quality compliance.

To help organizations take stock of where they presently stand, we asked a cross-section of IQVIA Quality Compliance subject matter experts to share their perspective on the most effective way to assess the health of a Quality Management System. Consider these quality system assessment insights and think about how they might help you run your own organization’s quality compliance health check. (more…)

The Future of QMS

The Future of QMS

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

Quality Management has traditionally been an area of manufacturing that was slow to adapt and change to technology shifts in the market. Over the past few years, enterprise Quality Management Software (QMS) systems have stepped up their game and caught up to the market by bringing functionality such as 3rd-party secure access, advanced analytics, and proactive monitoring to their portfolio stacks. (more…)

Auditing and Testing in the Global Pharmaceutical Supply Chain

Auditing and Testing in the Global Pharmaceutical Supply Chain

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

Auditing your suppliers is a key part of your quality and compliance improvement. A pharmaceutical company needs to insist on a confidential, in-depth audit of every part of the facility, operations, and quality systems relating to the materials it wants to purchase, including manufacturing and testing details.

In addition to regular, thorough manufacturing facility audits, the company should actively ensure that it or its brokers have reliable, up-to-date knowledge and verification of the drug substance upstream to ensure that materials really do come from approved sources. (more…)

Managing Compliance Risk with Integrated Asset Management Software

Managing Compliance Risk with Integrated Asset Management Software

Jim Erickson, President, Blue Mountain Quality Resources

Equipment and instruments touch every aspect of a product throughout the manufacturing process. These assets are a critical component of determining the quality of the product in each stage of the manufacturing process, from raw ingredients to final form, including packaging and shipping.

In addition, assets are capital intense to purchase and maintain over time. No matter the industry, facilities constantly need to increase the utilization and uptime of their assets in order to drive the highest return on investment. However, for Life Sciences manufacturers in particular, operational compliance is critical, and the risk of non-compliance in this area can completely cancel out the potential for realizing any measurable ROI. (more…)