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

Recently, I had the opportunity to explore practical tips for managing life sciences supplier risks along with 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 where we’ll review key takeaways from Pilgrim’s portion of that webinar and presentation. If you’d like to view the entire webinar, you can watch the on-demand version here.
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FDA Gateway System Updates: The Continuing Evolution of eMDR Submissions

FDA Gateway System Updates: The Continuing Evolution of eMDR Submissions

Bernard Jee, Product Manager, Pilgrim Quality Solutions

The U.S. Food and Drug Administration (FDA) announced, on June 8, 2017, that updates and changes are being made to its Electronic Submission Gateway (ESG) system for electronic medical device reporting (eMDR). If you are not subscribed to the FDA listserv, this information may not be readily available unless you visit the FDA Gateway website to see the full list of the planned updates.

In the interim, there are key updates that will impact various components of the submissions process.
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Get Quality in the Loop: 5 Key Processes to Integrate with Your Quality Management System (QMS)

Get Quality in the Loop: 5 Key Processes to Integrate with Your Quality Management System (QMS)

Massimo Franza, Senior Director of Software Engineering, Pilgrim Quality Solutions

Think about your quality system. When you initially automate a quality process, you begin by determining the ideal process flow, data you wish to capture, check points to be recorded, and how information should flow between members of your team.

But what about the intersection of where a quality process ends and another business process begins? Some of these intersections may be critical checkpoints between quality and compliance processes and the rest of your business. Notifying Quality about customer complaints, updating Production with nonconformance dispositions, or providing access to documents that need to be referenced from quality records are just a few of the examples of where quality systems interacts with the rest of the business in real-time.
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CDER Metrics Don’t Have to be Frightening

CDER Metrics Don’t Have to be Frightening

Cynthia Lambert, Regulatory Specialist, Pilgrim Quality Solutions

The FDA’s CDER Metrics program is set to launch early next year. Although this initiative is voluntary in 2018, it signals a new direction for how the FDA will approach future compliance and inspection practices. A risk-based, data-driven approach will become key to ongoing compliance and success. It’s important to understand and prepare for the upcoming CDER Metrics initiative even if you’re not yet ready to participate.
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ISO 13485:2016 Audit Readiness: Your Questions Answered

ISO 13485:2016 Audit Readiness: Your Questions Answered

Kari Miller, Regulatory & Product Management Leader, Pilgrim Quality Solutions
Cynthia Lambert, Regulatory Specialist, Pilgrim Quality Solutions

Last week, Pilgrim hosted a webinar titled “The Ultimate Guide to ISO 13485:2016 Assessment Readiness.” During the session, we presented comprehensive tips, best practices, and solutions to ensure that your team is prepared and confident when the assessor arrives. If you weren’t able to attend the live webinar, you can access the on-demand version here.

ISO 13485:2016 is a critical topic for medical device manufacturers, and we were delighted to address many questions on assessment readiness at the end of the presentation. Here are 5 interesting questions (with answers) from the webinar’s Q&A session that will help you better prepare for your assessment.
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Smart Quality Management: The Impact of Industry 4.0 on QMS

Smart Quality Management: The Impact of Industry 4.0 on QMS

Kari Miller, Regulatory & Product Management Leader, Pilgrim Quality Solutions

Last week, Pilgrim was privileged to address the 2017 American Medical Device Summit on a topic that all Quality professionals need to be thinking about. However, in many cases, Industry 4.0 sounds like a buzzword or it’s assumed to be a distant future opportunity. In reality, facets of Industry 4.0 are already here.

Industry 4.0, also known as Smart Factory 4.0, is labeled as the fourth industrial revolution, yet many don’t understand it or how it will impact the things they do; Quality Management is no exception. The Executives in your organization, however, are most certainly monitoring this paradigm-shifting strategy. Quality professionals should be as well. Quality professionals must ensure they are part of their company’s Industry 4.0 dialog.
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Make the Move: Solutions for Next-Generation QMS

Make the Move: Solutions for Next-Generation QMS

Kari Miller, Vice President of Regulatory and Product Management, Pilgrim Quality Solutions

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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The Path to ISO 13485:2016 Compliance – Are You Audit Ready?

The Path to ISO 13485:2016 Compliance – Are You Audit Ready?

Sandy Carson, Marketing Manager, Pilgrim Quality Solutions

The industry continues to be buzzing about ISO 13485:2016, and with good reason. The March 1, 2019 deadline is inching ever closer and some organizations are in full preparedness mode. Some have already even conducted mock audits. Others have been granted new product approvals with the new ISO criteria already coming into focus for them. Others are simply putting team plans in place for their implementation and/or upgrade to ISO 13485:2016-ready Quality Management Software (QMS) solutions.
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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

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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Imperatives for Next-Generation QMS – Key Takeaways from Last Week’s Webinar

Imperatives for Next-Generation QMS – Key Takeaways from Last Week’s Webinar

Roxane Napoli, Senior Marketing Manager, Pilgrim Quality Solutions

Is your quality system keeping up with regulatory changes, industry pressures, and the demands of global business? Most quality management software (QMS) solutions on the market today are struggling to meet the rapid pace of change in the Life Sciences industry. Last week, in conjunction with PwC, Pilgrim Quality Solutions presented a webinar on the next generation of QMS.
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