Pilgrim Quality Solutions Posts

Practical Tips for Managing Supplier Risks in the Life Sciences Industry – Part 2

Practical Tips for Managing Supplier Risks in the Life Sciences Industry – Part 2

Florian Czaszewicz, Industry Solutions Consultant, Pilgrim Quality Solutions, an IQVIA company

Earlier this week we shared the first in a two-part series on practical tips for managing supplier risks in the Life Sciences industry. In the previous post we discussed how resource planning, understanding the rules, preparation, and planning lay the foundation for a successful supplier-risk management program. In today’s post we’ll provide practical tips for setting goals, coaching recommendations, and best practices for supplier performance and risk monitoring.
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Practical Tips for Managing Supplier Risks in the Life Sciences Industry

Practical Tips for Managing Supplier Risks in the Life Sciences Industry

Florian Czaszewicz, Industry Solutions Consultant, Pilgrim Quality Solutions, an IQVIA company

It is critical today that risk-based thinking be embedded across respective quality and compliance activities throughout the Life Sciences. ISO13485:2016 regulations are driving the industry to this paradigm. I recently explored practical tips for managing life sciences supplier risks together with a team of consultants, including Dr. Carmine Jabri of E.M.M.A. International Consulting Group, Aida Markham of QACV Consulting, and Kenneth Christie of VTS Consultants, Inc. This post is the first in a two-part series that examines our findings, which you also can uncover on-demand here.
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Strategic Planning for the EU Medical Devices Regulation: Have You Spoken to Your Notified Body Yet?

Strategic Planning for the EU Medical Devices Regulation: Have You Spoken to Your Notified Body Yet?

Caroline Freeman, Principal Consultant, Consulting Services, IQVIA
Phil Johnson, Senior Director, Quality & Compliance Services, IQVIA

We are now almost one-third of the way into the 3-year transition period for the EU Medical Devices Regulation (2017/745/EU) (MDR).

The MDR has significant economic impact on manufacturers — not just the cost of implementing the new regulations for new products, but ensuring legacy products meet the new requirements, as there is no grandfathering from the current EU Medical Devices Directive (MDD). The MDR has a big impact on distributors and importers, as well as manufacturers. This means that some distributors/importers (Economic Operators) of CE-marked products may cease their involvement under the MDR. The medical device supply chain is quite complex, often with involvement of multiple distributors, from manufacturers to patients. It is a global issue, as it affects all manufacturers/distributors that sell in to the EU.
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Pilgrim Quality Solutions: 25 Years of Quality, Compliance, and Success

Pilgrim Quality Solutions: 25 Years of Quality, Compliance, and Success

Pilgrim Quality Solutions, an IQVIA company

This week, Pilgrim Quality Solutions proudly celebrates 25 years of commitment to helping hundreds of organizations around the globe manage product quality with confidence, enhance patient safety, and be more prepared for audits than ever before. Pilgrim has pioneered quality management software solutions since 1993, bringing industry best practices to the Life Sciences sector, and partnering with the world’s leading companies to enhance their quality processes, positively impact their financial performance, and achieve regulatory success.

In honor of this accomplishment, we look back over the last 25 years of events that have defined Pilgrim as the leading provider of enterprise quality and compliance management software and services for the Life Sciences and other highly regulated industries.
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Who Moved My Cheese? Address, and Conquer, the “Change Barrier” for Enterprise Quality Management

Who Moved My Cheese? Address, and Conquer, the “Change Barrier” for Enterprise Quality Management

Brian Myers, Strategic Account Executive, Pilgrim Quality Solutions, an IQVIA company

The business case for quality is typically very strong, yet we still find projects mired in indecision and inaction. Spend enough time in the Quality and Compliance space working with regulated Life Sciences companies of varying size, organizational maturity, and product breadth, and you start to notice some striking similarities when it comes to reasons why really good enterprise Quality Management Systems (eQMS) projects stall or never even get started. The obvious answers are business priority, funding, and project resources. The more insidious reason is fear of, resistance to, or a complete lack of planning for an inevitable change.
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Validated Cloud Solution… absolutely!

Validated Cloud Solution… absolutely!

Ninoshka Ortiz, Senior Validation Specialist, Pilgrim Quality Solutions, an IQVIA company

Life Sciences organizations are progressively searching and shifting to cloud-hosted environments to increase efficiency and reduce costs. But to do so, those organizations must be able to select a cloud service provider that helps to assure the confidentiality, integrity, and availability of data stored in the cloud.

Cloud-hosted environments help Life Sciences organizations with validation challenges and ease the process of qualifying cloud infrastructure with emerging capabilities and tools. In addition to the methods and controls to support the achievement of continuous quality and regulatory compliance, these organizations are seeking ways to maintain their Quality Management Systems (QMS) in a secured and validated state.
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Benchmark the State of Your QMS and Take On Quality’s Next-Gen

Benchmark the State of Your QMS and Take On Quality’s Next-Gen

Last week, we discussed the much-buzzed about topic of Next Generation Quality, commonly referred to as Quality 4.0. We posed the question: What does a Next-Generation Quality Management System (QMS) look like for a Life Sciences organization?

To capture a snapshot of the current QMS landscape, Pilgrim Quality Solutions recently conducted a market research study of quality and compliance professionals from the Top 2,000 Pharmaceutical, BioTech, Medical Device, and Combination Product companies on the “state of the state” of their current QMS capabilities and needs.
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Bridging the Gap to Quality 4.0

Bridging the Gap to Quality 4.0

Larry Ferrere, Senior Director of Business Marketing, Pilgrim Quality Solutions, an IQVIA company

It is still amazing to me the number of companies that are managing their quality and operating in SharePoint, Excel, and with paper-based SOPs and disparate systems. Thus, it shouldn’t surprise me, but it does, that so many companies do not know the level of their Quality Maturity or their Cost Of Quality. If they say they do know, they inevitably over-rate themselves as much more mature than the norm or where they truly are, and they understate their total Cost Of Quality.
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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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Supplier Participation Required: Time is Short, Supply Chains are Long, and Compliance is Required

Supplier Participation Required: Time is Short, Supply Chains are Long, and Compliance is Required

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

In the past few years, there has been a lot of focus on how organizations manage their suppliers. The reality for most is that their supply chains are getting longer, the need to work through those supply chain is getting shorter, and the regulatory requirements with regard to supplier management are becoming more broadly encompassing.

The most critical medical device regulatory requirements – ISO 13485:2016, ISO 9001:2015, 21 CFR Part 820, and EU MDR – have increased focus on the manufacturer’s responsibility for supplier performance. For instance, in the pharmaceutical industry, 21 CFR part 211 and ICH Q10 specifically address the management of suppliers.
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