Pilgrim Quality Solutions Posts

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

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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Prepare Yourself: Adverse Events Code Update Coming Spring 2018

Prepare Yourself: Adverse Events Code Update Coming Spring 2018

Bernard Jee, Product Manager, Pilgrim Quality Solutions

As part of the enhancement to the electronic Medical Device Reporting (eMDR) system, the U.S. Food and Drug Administration (FDA) has indicated in its initial 2017 announcement that there will be an update to the Adverse Events codes. In particular, the code sets used in eMDR fields F10 and H6 are being harmonized with the International Medical Device Regulators Forum (IMDRF) Adverse Events Reporting terminologies, a new international guideline for coding medical device adverse events.

Based on conversation with the FDA and National Institutes of Health (NIH), the update is scheduled for implementation on April 6, 2018. An initial rollout in the pre-production environment will take place prior to April 6, 2018, allowing submitters a chance to conduct testing of their submission process to determine if any changes are required to accommodate these new codes.
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The Quality Trade-Off Paradigm

The Quality Trade-Off Paradigm

Kevin Lee, Industry Solutions Consultant, Pilgrim Quality Solutions

In my role as an industry solutions consultant for an enterprise Quality Management Solutions (QMS) provider, I get a lot of insight into the quality challenges facing manufacturing and service organizations. I’ve concluded that a lot of those challenges are internally generated.

The source, more often than not, is a communication issue, or a lack of communication between internal parties that are not on the same page regarding goals, objectives, strategies, or priorities. The result, far too often, is what some would call organizational paralysis. It’s what happens when multiple parties can’t agree to agree. No one wins, but everyone loses.
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Your QMS: Choose a Partner, Not Just Software

Your QMS: Choose a Partner, Not Just Software

Joshua Centner, Industry Solutions Group Manager, Pilgrim Quality Solutions

Selecting an enterprise-wide Quality Management System (QMS) provider that will allow you to meet all of your quality management goals might seem overwhelming. To help allay the intimidation factor, last week, I wrote a piece titled Don’t Be Shortsighted When Evaluating eQMS Solutions that examined what constitutes a successful QMS vendor evaluation process, one that establishes a lasting partnership between a client and a vendor. The discussion asserted that the determining factor is whether a company enters into the evaluation process with a long-term vision for organizational quality, versus simply conducting a point solution selection.
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Don’t Be Shortsighted When Evaluating eQMS Solutions

Don’t Be Shortsighted When Evaluating eQMS Solutions

Joshua Centner, Industry Solutions Group Manager, Pilgrim Quality Solutions

As a Sales Engineer for over a decade, I continually engage with clients through every step of the sales cycle, from the initial inquiry and Request for Information (RFI) phase, all the way beyond the selection of software solutions. Over the years, I have observed companies engage in a tremendous range of software selection strategies.

Distilling down all of those observations has revealed the one main factor that I truly believe creates a successful evaluation process, one that establishes a lasting partnership between a client and a vendor. That factor is whether a company enters into the evaluation process with a long-term vision for organizational quality versus simply conducting a point solution selection.
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Combination Products: Past, Present, and Future – Part 3 of a Series

Combination Products: Past, Present, and Future – Part 3 of a Series

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

In the first two parts of this series, Combination Products: Past, Present and Future, we reviewed the historical path of combination products and the complex road to regulatory and quality compliance for this product category, leading up to today’s current state. It is important to recall that Combination Products is its own product category, independent of Medical Device, Drug, and Biologics. We discussed that fact that combination products have their own cGMP (21 CFR Part 4), but the cGMPs of the constituent parts (i.e. devices, drugs, and/or biologics) must not be neglected either.
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Combination Products: Past, Present, and Future – Part 2 of a Series

Combination Products: Past, Present, and Future – Part 2 of a Series

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

In Part 1 of this series, Combination Products: Past, Present, and Future, we focused on the past, a necessary step in understanding just how far we’ve come in this space. We also reviewed the definition of a combination product before strolling down origins lane, to ensure proper focus. As witnessed through the lens of history, the road to regulatory and quality compliance for combination products was and is a complex one, and in many ways, the regulatory path for these products is still under construction.
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2018 Resolutions: Make Quality & Compliance Collective Top Priorities

2018 Resolutions: Make Quality & Compliance Collective Top Priorities

Do you ever wonder how many individuals truly commit to their New Year resolutions? How many actually follow through? The figure is difficult to calculate because more often than not, there is no system of checks and balances, no accountability for individuals’ behavior. In 2018, consider not only your own personal Quality and Compliance goals and resolutions, but engage your colleagues in sharing them with you. Be one another’s support network and ensure that those intentions are realized. Make the behaviors that support them a part of your organization’s Quality Culture for 2018.
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Happy Holidays from the Pilgrim Quality Blog Team

Happy Holidays from the Pilgrim Quality Blog Team

It has been our pleasure this year to share with you our perspectives on the latest topics in quality, compliance, and risk management. We wish you a delightful holiday season and a prosperous 2018.
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Not-So-Standard SOPs: What You Need to Know

Not-So-Standard SOPs: What You Need to Know

Davor Milosevic, Quality Assurance Manager, Pilgrim Quality Solutions

Formal written Standard Operating Procedures (SOPs) are required both by the Food & Drug Administration (FDA) and European Medicines Agency (EMA). While the term standard suggests “business as usual,” there’s definitely nothing standard about what they represent. SOPs, in part, demonstrate compliance and say to inspectors that you know what you are doing and why.

However, for the last couple of years, SOP deficiencies have been one of the top findings in FDA audits on both the drug and device manufacturing sides. In fact, almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs, or lack of compliance in following them, within an organization. As such, the entire Quality Management System (QMS) of an organization could be severely compromised due to SOP defects or mismanagement of the related processes.
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