ISO 13485:2016 Compliance: Yes, It’s That Urgent

ISO 13485:2016 Compliance: Yes, It’s That Urgent

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

We’ve been talking about getting ready to meet the ISO 13485:2016 deadline for a while now, urging organizations to perform regulatory gap assessments, get a compliance update plan in place, and execute. In fact, I just reminded everyone again a few days ago in my blog about the steps to take to get compliant prior to March 1, 2019. So do we really need to address it again? Well, yes, because it is that urgent!

Timing Urgency

If your organization is currently certified to the ISO 13485:2003 standard, then it is important for you to know that before March 1, 2019, re-certification to ISO 13485:2016 will be required for your organization. You’re probably thinking that’s over a year away, we’ve got time! But consider this — from personal knowledge I can tell you that you are definitely not alone in the need to get this done within the next 12 months, and the queue for ISO 13485:2016 certification is long! Therefore, if you’re not done yet, or you haven’t even started, get some help to expedite the process.
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ISO 13485:2016 – The Countdown is On!

ISO 13485:2016 – The Countdown is On!

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

How much effort will it take to get your organization ready for ISO 13485:2016? The February 28, 2019 deadline is now just one year away, and many organizations need to take advantage of every minute between now and then to be compliance-ready. Busy registrar schedules, combined with your company’s certificate expiration, mean that you may have less time to prepare than you think.

Medical device manufacturers that aren’t prepared for the change will need to do some heavy lifting with regard to quality management practices and processes to stay compliant with the updated standards. Do you know the level of effort needed by your organization to get ready for the new version of ISO 13485? Here is some insight on where to start.
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The Need for QMS Transformation & Structured QMS Data

The Need for QMS Transformation & Structured QMS Data

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

As product recalls, product bans, drug shortages, plant shutdowns, and enforcement actions continue to rise, industry and regulators alike are looking for answers on how to change the perspective of the Life Sciences industry from one of Compliance to one of Quality.

Is the solution to increase the amount of data we capture and report within our documents? After all, we so carefully record a great deal of data in a Quality Management System (QMS). No, data in and of itself, is not the answer. While data/metrics go a long way toward accomplishing the shift from compliance to quality, that data needs to be transformed into intelligence that is informed, actionable, proactive, and predictive.
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The Quality Trade-Off Paradigm

The Quality Trade-Off Paradigm

Kevin Lee, Industry Solutions Consultant, Pilgrim Quality Solutions, an IQVIA company

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, an IQVIA company

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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Quality Doesn’t Matter! Say it isn’t so!

Quality Doesn’t Matter! Say it isn’t so!

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

Suppose you have just delivered a Quality Management Solution (QMS) to your customers, and immediately afterward, you receive an invitation to a webinar titled “Why Quality Doesn’t Matter.” What do you do? You sign up!

The anticipation of what Dr. Marla Phillips, Ph.D., Director of Xavier Health, Xavier University, might impart based on this webinar title, was exciting, maybe even a little bit anxiety- inducing. After all, quality is what we strive for, and it’s been the focus of industry for decades. In Life Sciences, not only are we striving to improve quality, we are equally focused on ensuring our global regulatory compliance.
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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, an IQVIA company

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, an IQVIA company

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, an IQVIA company

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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