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…)

Next on the MedTech QMS Calendar

Next on the MedTech QMS Calendar

Phil Johnson, Senior Principal, IQVIA Quality Compliance

Medical Device and In Vitro Diagnostics (IVD) manufacturers have been busy the last few years ensuring that their Quality Management System (QMS) met the requirements of ISO 13485:2016 and the Medical Device Single Audit Program (MDSAP). It was an interesting time as Notified Bodies (NB) and certification bodies also came up to speed on the new requirements and increased level of surveillance on manufacturers. MDSAP introduced new auditing concepts and non-conformance handling, and also introduced a new level of compliance to Quality systems, resulting in a more rounded system for addressing global regulatory needs. (more…)

Quality Management and Design Control Requirements for MedTech

Quality Management and Design Control Requirements for MedTech

Todd Neal, Product Manager, IQVIA Quality Compliance

For any MedTech company, understanding and supporting a robust and finely tuned internal Quality Management System (QMS) can be a competitive advantage rather than just a cost of doing business. And it’s imperative. Medical device manufacturers around the globe are required to maintain a Quality Management System to ensure safety and efficacy. Subsequently, they are also required to comply with regulations regarding Design Control for medical devices to ensure that specific requirements for their devices are met.

Whether an organization is adhering to the FDA and its Quality Systems Regulation (QSR), the European Union and its Medical Device Regulation (EU MDR), or other regulatory authorities and standards for Design Control, it is important to manage the ongoing Quality Management process and provide documented evidence that a well-defined, controlled process is in place and has been properly executed. Under EU MDR, not only must technical documentation be current and demonstrate conformance with requirements, but it must also reflect the development stages applied to the design of the device. (more…)

Take Charge of your EU MDR Preparedness as Notified Bodies Resources Still Lag

Take Charge of your EU MDR Preparedness as Notified Bodies Resources Still Lag

Caroline Freeman, Principal Consultant, IQVIA Quality Compliance

The MDR affects all medical device manufacturers that sell to the EU, and its economic impact is already being felt, not just in the cost of implementing the new requirements for new products, but ensuring that legacy products meet the MDR, as there is no grandfathering from the current EU Medical Devices Directive (MDD). Manufacturers of all medical devices above simple Class I will need the services of an MDR designated Notified Body at some time between now and May 2024, with the exact timing being dependent on the validity of existing certificates to the MDD or the Active Implantable Medical Devices Directive (AIMDD). (more…)

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…)