USDM Life Sciences

Thursday, January 18, 2018

Drug Safety System Solutions: A Second Opinion

Scenario: Companies A and B own the same drug safety software and have spent millions over the years to purchase, license and upgrade. While nobody likes work, company A’s employees are very productive and think the software helps them do a better job. Meanwhile, company B’s employees think the software is a pain to use, makes their job miserable and they cannot be as productive as they like because they spend half of their time fantasizing about shooting the computer screen. Now be honest, do you work for company A or company B?

When you initially chose that drug safety system, several requirements guided your decision to improve upon your previous system with high hopes that the new software would keep you within regulatory compliance.

If you are like company one, then congratulations. You have done better than most of the industry. If you are like company number two, then ask yourself: is the problem the software, lack of knowledge or shrinking budgets? If your IT staff or host company is withholding advice or assuring you that other options are expensive or impossible, then maybe you need another opinion.

Promising that we can make the system ‘fun to use’ is like student council candidates promising all day recess and free cokes. USDM cannot make working ‘fun’ but we may be able to leverage our expertise and show you how to identify ways to improve your product safety system, regardless of who is making the changes to your system. Whether you need your software customized or a more effective workflow design, we can explain the options, impacts and steps to get your system working up to its full potential.

About the Author

Mark Ciresi has 28 years of experience improving business productivity through the application of computer system solutions. Extensive knowledge of all aspects of computer systems and project life cycles in the field of health sciences. Experience is balanced between business analysis, leadership, validation and development roles. Since 2003, he has specialized in the customization of Argus Safety systems (Versions 3.3 -7.06) for pharmaceutical, biotechnology and CRO companies.

About USDM Life Sciences

USDM Life Sciences is a global life science and healthcare services company, providing strategy and compliant technology solutions to regulated industries. If you work in Life Sciences or Healthcare, partnering with USDM Life Sciences makes it easy to accelerate innovation and maximize productivity. USDM Life Sciences only focuses on regulated industries and has built trusted partnerships with the most innovative technology companies in the world, and boast a staff of industry leading experts in the areas of technology and compliance.

Tuesday, November 7, 2017

Time to Prepare for MDR & IVDR – See You in Florida?

Join Jay at the MDR & IVDR EU Conference, December 4-6 in Orlando, Florida!

On 5 April 2017, the European Medical Device (MDR) and In Vitro Diagnostic Medical Device (IVDR) Regulations were published in the Official Journal of the European Union – the last step in their long and arduous journey. The MDR applies from 26 May 2020 and the IVDR applies from 26 May 2022. These new regulations were developed because “… a fundamental revision of those Directives [on medical devices, active implantable medical devices, and in vitro diagnostic medical devices] is needed to establish a robust, transparent, predictable and sustainable regulatory framework … which ensures a high level of safety and health whilst supporting innovation (Recital 1).”

The 2 new regulations fundamentally change the way medical devices are regulated in the EU – and impose significant new responsibilities on all economic operators. These regulations “…set high standards of quality and safety … in order to meet common safety concerns as regards such products (Recital 2).” Among the many changes that the MDR and IVDR introduce, they up-classify many device types; regulate as devices products that were not previously regulated; introduce an EU UDI System; enhance a manufacturer’s Quality System requirements; introduce new requirements for clinical evaluation; impose significant new requirements related to post market surveillance; and drastically change the relationships and review processes involving manufacturers, Notified Bodies, and Competent Authorities. This will all affect the conformity assessment of devices being brought to market in the EU.

Though there are many questions yet to be answered about how the MDR/IVDR will actually work, many guidance documents still in development, and ambiguity around the new Eudamed, manufacturers cannot afford to delay implementation. There are too many changes affecting too many processes to wait until everything is defined and well understood. To that end, USDM is proud to be the primary sponsor of the MDR & IVDR EU Conference 2017, being held 4-6 December in Orlando, FL. We are hosting a pre-conference workshop on Monday, December 4 focused on developing and maintaining the product identification and device master data needed to meet the needs and challenges of the evolving global regulatory and commercial landscape. I hope to see you in sunny Florida…

About the Author

Jay Crowley is the Vice President of the UDI Services and Solutions at USDM Life Sciences. Jay was most recently Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for FDA’s Unique Device Identification system.

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What do Guinness and UDI Have in Common? Both are in Ireland, of course...

We are excited to be at the Medtec Ireland conference in Galway this week. As an Irish descendant and a Guinness aficionado – I always enjoy my trips to the Emerald Isle. Ireland is home to many medical device manufacturers (8 of the world’s 10 largest medical device companies are located in Ireland – and 18 of the top 25 devices companies have a base in Ireland) and a good deal of sophisticated manufacturing of devices that are distributed globally. And of course, the big topic for EU countries (as well as those countries that leverage the European regulations of devices – e.g., Norway, Liechtenstein, Iceland, Turkey and Switzerland) is the transition to the new medical device regulations (the MDR and IVDR) – and ALL the many changes that this entails. This should be a great opportunity to share understanding and progress to date.

One of the more interesting and complex challenges for device manufacturers implementing the MDR/IVDR (especially those that are not physically located in Continental Europe) are the new requirements for economic operator involved in the distribution of their medical devices. The MDR/IVDR places very specific obligations on distributors and importers to ensure that the devices that they place on the EU market on behalf of a device manufacturer are compliant with the regulations and that any issues are addressed as quickly and effectively as possible. And of course, the way that we tie all the devices and economic operators together is through UDI. This increased scrutiny and clearly identified roles and responsibilities will provide more transparency and help secure the supply chain.

Specifically, the regulations require that importers and distributors verify, before distributing a device, that the manufacturer has properly assigned a UDI to the device. This also includes assuring that the UDI is in compliance with the rules of the chosen issuing agency. This applies not just to the device/label UDI – but to the UDIs on various higher levels of packaging as well. And though not specifically stated, it would seem that UDI assignment in a vacuum is of little use – so the UDI must be properly represented in the UDI carrier (AIDC and HRI) and the product master data submitted to Eudamed’s UDI Database must be valid and up to date. Moreover, when an importer or distributor believes that a device is not in conformance with the regulations, they must NOT place the device on the market until it has been brought into conformance – and must inform the manufacturer (or their authorized representative). And, if the importer or distributor believes that the device may presents a serious risk or is a falsified device – then they must also inform the relevant competent authority. A lot of new responsibilities for importer or distributor that will obviously require more and better communication between and among the various parties…

About the Author

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Continuous Cloud Validation – the Death Knell for the Risk Based Approach?

25 years have passed since the Good Automated Manufacturing Practice (GAMP®) forum was founded to deal with the evolving regulatory expectations for good manufacturing practice (GMP) compliance of manufacturing and related systems. GAMP published its first guidance in 1994.

Over the years, GAMP® has become the defacto approach to dealing with these expectations, and has morphed into leveraging a “Risk Based Approach” to tackling the nuances of computer systems qualification and validation. It has been 9 years since the last version of the guide – GAMP® 5 was published.

With the avalanche of companies moving their infrastructure and systems to the cloud, what does that mean for that approach? How do you keep up with changes to your compliant systems occurring continually and often without the option of choosing not to embrace them?

Don’t get me wrong, risk management and validation still go hand in hand. It is still critical to focus the right level of attention on the critical elements of your system, and if the number of changes per release are of a “manageable” level – and can be assessed on a case by case basis (as is the case with some cloud systems), then the approach is applicable.

But – what about systems that don’t have changes limited to an established cadence – the “published release” approach? More and more cloud vendors are realizing the power and advantages of making continual changes to their platforms. In these cases – where hundreds of small changes can occur on a weekly basis, the traditional “Risk Based” approach is no longer viable. It simply is not possible to assess that many changes and produce an accurate mitigation. In fact – it becomes riskier to try to do this as manual inputs are so contingent on an individual’s own interpretation and there is not enough time to produce a fully reviewed and quality mitigation strategy for the inherent risks.

A new “hybrid” approach is needed; an approach that was not possible a few years ago. Leveraging advances in technologies such as Automated Testing Tools, it is possible to designate specific elements of a systems architecture that you want to focus upon (utilizing a risk based determination process) and perform “Continual” or “Adhoc” testing of those elements to ensure the data integrity is not compromised. The outputs from these tests can be tailored to produce bespoke, real-time dashboards of platform operation and performance, showing the compliant state at any given time.

It could be argued that this approach, if implemented correctly, is in fact much less risky than the traditional approach. Since the elements tested can be determined once, and repeatedly tested ad infinitum, the chances of an unintentional adverse effect on cGxP functionality made by a cloud vendor being missed by a manual assessment of release notes is drastically reduced.

New tools enable new approaches. The approach is still risk based, but it has evolved – it is more thorough. In fact, the necessity to focus only on highly critical elements can even be removed - since a one-time bout of test creation enables continual testing henceforth. You could, if you desired, decide to test everything, all the time.

And that is where this all began. In the early nineties companies were more often than not testing everything, to the nth degree. There was far too much money, time and resources being spent. So naturally, risk based approaches made sense. It’s now possible to more accurately, and more efficiently test everything – if so desired – providing even more assurance of your cloud’s continued compliance.

USDM is already working with cloud vendors on these approaches. For more information contact usdm@usdm.com.

About the Author

David Blewitt is the Vice President of Cloud Compliance at USDM Life Sciences. David is an accomplished Life Sciences Regulatory and IS Compliance Professional with extensive hands-on and leadership experience in the Pharmaceutical, Medical Device, Biotech and Blood Management Industries, specifically in the fields of; Computer Systems Validation, Risk Management, Issue Investigation – Root Cause Analysis and Remediation, Quality Assurance, Software Development Lifecycle, Lean IS Compliance Enhancement Initiatives, Business Analysis, Product Lifecycle Management and Systems/Process analysis with Compliance Roadmap development.

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Digital Transformation (Dx) in Life Sciences Starts with a Modern ECM like Box

Life Sciences companies are focused on drug development and manufacturing that traditionally have long, multi-year R&D cycles. While this is business as usual for Biopharmaceuticals, other industries are jumping forward by leaps and bounds by leveraging Digital Transformation principals and modern tools such as real-time analytics, IoT, bleeding edge computing, and Artificial Intelligence (AI) processing. So, how do Life Sciences companies hop on the Dx ‘band wagon’? It all starts with a cloud content management layer like Box.com.

Biopharmaceuticals generate copious amounts of content across their organizations, ranging from R&D to Manufacturing to Commercialization. Managing this content with varied regulations and fluctuating business processes presents a unique challenge. Enterprise Content Management (ECM), formerly known as Enterprise Document Management (EDM), is not a new concept but the legacy giants such as Documentum and OpenText catered to this issue with lots of operational overhead such as a qualified infrastructure layer, ongoing maintenance, support staff, hefty license fees, long upgrade cycles, and user disruption for any changes.

So what are some of the factors that make a cloud ECM System a must-have for Life Sciences?

1. All Cloud – By utilizing cloud based storage there is a massive reduction in operational overhead in the form of service staff, server maintenance costs, licensing costs, sourcing software time, and upgrade costs. A multi-tenant environment allows life sciences to achieve economies of scale on this significant expense.

2. Readily Available Integrations – The advantage of an open-system is that the solutions of tomorrow are coming faster than ever, and using an ECM platform with available connectors and APIs allows integrations to happen easily and quickly compared to the months of custom development required with legacy solutions.

3. Global – Todays business operations know no boundaries. The ability to securely interact with other organizations, partners, sites and manufacturing facilities has been elevated from a ‘nice-to-have’ to a ‘must-have’. Cloud-based ECM allows content to be accesses securely from anywhere without the need for slow, costly, and often unavailable VPNs.

4. Ability to Expand – Content Management Solutions span entire enterprises and are often utilized for only a fraction of their potential. With licensed-based cloud solutions like Box.com, integration with numerous applications is often turnkey, governance principles can be consolidated, and to expand to other teams and departments, only additional licenses need to be provisioned.

Queue box.com. Box, known for its File Sync & Share (FS&S) services, is much more than that. Box is a content management platform layer that meets all the above requirements for a modern ECM Platform and can be used for other GxP operations such as a Clinical trial Operations, managing manufacturing batch records or providing on-the-field training for Medical Liaisons. The cloud ECM band wagon is ready to go. You just need to jump on.

USDM Life Sciences is a certified Systems Integrator of Box and Digital Transformation Solutions. Contact usdm@usdm.com for more information.

About the Author

Manu Vohra is the Vice President of Enterprise Content Management Services and Solutions at USDM Life Sciences. He is a seasoned professional with two decades under his belt deploying content managem;ent solutions for Life Sciences while running operations within several IT functions supporting Drug Discovery to Commercialization. He specializes in guiding Biopharmaceuticals in developing long term content management strategies by applying Digital Transformation principles and technologies.

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Digital Transformation in Med Device – How cloud-based field service can help your business go 10X!

Notes from a Lonely Life Sciences Digital Transformation Junkie (A.K.A Bryan Coddington)

Digital Transformation isn’t about meeting your goals; it’s about blasting through them and reinventing your business. To do that, you often need to throw out the book and find solutions that are new, bold, and even disruptive to your team. As a medical device company, those solutions aren’t just about the latest and greatest technology but ones that also meet the rigor and requirements of the quality organization.

We all know moving to the cloud is a big part of going digital but in Regulated/GxP business areas, such as field service, the qualification of a platform can be a daunting challenge to even the most experienced quality team. But don’t fear the cloud, for it can be as easy as identifying three things - What, Who, and How.

“What” means what are you qualifying? What does the cloud system consist of? Things like configuration, integration, traceability, change control, release management, disaster recovery, user requirements, and IQ/OQ/PQ must all be documented, risk assessed, and tested if needed.

“Who” means who is responsible for the items listed above? A cloud vendor is responsible for their infrastructure, release management, and disaster recovery. As a customer of a cloud platform, you are responsible for documenting and testing your configuration, integrations, user requirements, risk assessment, traceability, IQ/OQ/PQ, and change management.

“How” is about how to accomplish the items you are responsible for. It starts with performing a risk-based qualification effort and then continuing to leverage the supplier’s activity to eliminate the need to re-qualify low risk items. From there, analyze any custom elements and specific configurations against the latest system requirement spec (SRS) and OQ. You then determine gaps and create new scripts (PQ) if needed on top of current SRS and OQ. Finally, you must establish a release upgrade strategy by performing an analysis and testing any issues with step by step guidance.

Now that you know the basics for qualifying a cloud-based field service application, how can it really transform your business? Imagine an application that was built from the ground up to be mobile and collaborative with enterprise analytics and customer/partner communities. But because it’s cloud, you might be thinking that not all areas have Wifi connectivity - and that’s ok. Today’s cloud-based field service applications, like ServiceMax, have offline capabilities so your team can access their data anytime from anywhere. We can go even further with predictive maintenance and IoT, connecting devices out in the field to your application to automatically create alerts and assign technicians.

So how do you be bold and disruptive within your organization to implement a cloud-based field service application? The numbers tell the story. 18% increase in productivity, 13% increase in service revenue, 11% reduction in costs, and 11% increase in customer satisfaction. Management will want this type of change and as you read above, your quality team can sleep at night knowing that cloud platforms like ServiceMax can be qualified.

About the Author

Bryan Coddington is the Vice President of Cloud Technology at USDM Life Sciences. For almost a decade, Bryan has been a senior executive in the Cloud space with in-depth knowledge of sales, marketing, and service and support processes and best practices, helping companies maximize their investment in cloud-based CRM applications.

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The Same – Yet Different

Over the past 15 years, I have been fortunate enough to travel around the globe discussing and developing Unique Device Identification (UDI). I am always struck by how similar – and yet interestingly different – people, societies, and countries (as well as the regulation of medical devices) are around the world. Nowhere is this truer than in China. Though the people of China are similar in many ways, there is so much that is different. There are differences in the language (both written and spoken), the food, the culture, the politics, and the “eastern” toilets (enough said). And at least for those of us from the east coast of the US – I find it very interesting that the hour is the same – just half a day ahead…at least I don’t have to change my watch!

I am reflecting on these similarities and differences as some of us were in Hangzhou, China, for the 8th China International Medical Device Regulatory (CIMDR) Forum two weeks ago. The key question that we have been wrestling with – for over 8 years now – is how “similar” (if at all?) will the China Food and Drug Administration (CFDA) UDI scheme be to the US and EU regulations? And, when does something that is similar, yet different, become so different that it can no longer be considered the same or similar?

As previous posts have discussed – the goal of the Global Harmonization Task Force (GHTF) and International Medical Device Regulators Forum (IMDRF) UDI guidance documents are to provide a common regulatory framework to follow – such that a “globally harmonized approach” (whatever that really means?) to UDI would be realized. As we have already seen with the EU MDR/IVDR UDI regulations – “globally harmonized” does not mean “the same.” There are critical differences between the US and EU UDI regulations – even though they are both based on the same (global) guidance documents.

At least from what we could discern from the presentations and conversations at the Forum, we are likely some time away from seeing a UDI proposal from CFDA. They continue to work on device nomenclature/classification and seem to want to focus their UDI activities initially (at least for now) on implants. (More to come on this as it becomes available.) For me, these similarities and differences beg larger questions – can (should?) companies continue to strive to produce a single labeled/packaged device for global distribution? When are there enough differences (e.g., languages, “UDIs”) that a country/region-specific label is warranted? I know our collective goal has been a single global UDI – but I am wondering if this is going to be sustainable moving forward…

About the Author

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