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by Mark Ciresi

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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.

 

by Erin Northington

Erin IT Blog

You’ve been assigned the responsibility of steering your emerging life sciences company towards commercialization. As a leader in IT you need to make calculated and informed decisions to accelerate your journey. Where do you start?

These 5 tips will help you get organized quickly and intelligently:

1. Take the time to assess your current situation. To build anything successfully, it’s important to first assess what you already have and how those resources can be utilized to serve your goals. The foundation for your plan will be found in answering to these questions:

  • What are your current and future business needs and are your systems scalable to these needs?
  • What/where are the various documents and informal procedures and processes?
  • Where are you with your current IT compliance and where do you need to be?

2. Identify critical systems needed and document business requirements. Remember that paper systems are completely fine for starting out! Consider these systems:

  • E-Signatures: Have you notified the FDA?
  • Documents: Where are your different documents stored?
  • Quality (CAPA, adverse events, training, tracking and trending)
  • Inventory management/control
  • Distribution
  • Lot release

After identifying the systems, determine the risk and prioritize them as per your business requirements. 

3. Develop an IT Strategic and IT Compliance Roadmap. While creating your roadmap, make sure to consider these points:

  • Establish your IT Governance and Content Governance policies
  • Plan to be scalable and dynamic 

4. Plan for Cloud. Avoid on-premise solutions as much as possible. If you do need to have on-premise solutions, drive the move to cloud-based solutions in order to reduce support overhead and infrastructure costs. Develop your plans to ensure your cloud systems are GxP compliant.

5. The key to success is to work smart. Utilize resources that provide solutions in a time and cost-effective manner. Remember this:

  • Compliance, Validation, and Auditing as a service can drive your implementation timelines, accelerate clinical trial timelines and help to meet business demands, and allow you to utilize precious headcount for more strategic purposes. 
  • Use Validation and Qualification Accelerator Packages to save time, money, and resources. 
  • Go with best practice approaches instead of trying to reinvent the wheel yourself. 

Recognize that for everything you are trying to do, hundreds if not thousands of people before you have also done the same thing. Keep it simple, and don’t try to do everything at once. Know that an out-of-the-box workflow has been developed by software providers with the best approaches used by many companies. 

Bonus Tip: Why make the journey alone when you can travel with an experienced companion? Connect with USDM to see how we can be a valuable partner on your journey to commercialization.  

 

 

About the Author

Erin Northington 85x105 rightErin Northington is the Vice President of Emerging Life Sciences and Clinical Solutions. Erin has two decades of experience in Clinical Applications, Business Relationship Management and Project Management. She also has a background in GCP compliance, vendor evaluation and management, systems validation and implementations, as well as process evaluation and improvement. She specializes in managing global enterprise-wide IT implementations of technology solutions. Her wide-ranging life sciences experience includes managing customer relationships for assigned business units, direct line management, strategic planning, product and applications.

 

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.

 

by Jay Crowley

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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 6Jay 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.

 

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.

 

by Jay Crowley

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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

Jay Crowley 6Jay 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.

 

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.

 

by David Blewitt

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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 8David 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.

 

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.

 

by Manu Vohra

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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 85x105 rightManu 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 management 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.

 

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.

 

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

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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 85x105 rightBryan 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.

 

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.

 

by Jay Crowley

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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

Jay Crowley 6Jay 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.

 

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.

 

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

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Salesforce is an amazing platform that has remained one of the most innovative and disruptive technologies since its inception in 1999. Along with CRM, customers are finding new ways to extend the platform throughout their organizations to take advantage of its powerful feature-set, such as collaboration, workflow, mobile, and reporting – to name a few.

Using Salesforce for GxP applications is a relatively new and exciting area for Life Sciences professionals. For compliance reasons, users tend to be more cautious because they are relying on someone outside of their organization to provide and maintain elements of the application. We are committed to helping people successfully and compliantly move to the cloud, optimize their processes, and digitally transform their businesses. Here are 5 tips I’ve found lead to success when using Salesforce for GxP:

1. Qualify the platform: Salesforce, as a cloud vendor, is responsible for various compliance elements such as change control, audit history, and software development SOPs. As a customer, you are responsible for obtaining proof of these procedures. Depending on your own compliance requirements, this may require an onsite audit. You are also required to test and document the core features of the Salesforce platform such as security, permissions, object/field configuration, audit history tracking, and many others. Sound daunting? It can be if you haven’t done it before. The good news is that if it’s done correctly, the Salesforce platform qualification creates a baseline for incredibly powerful, user-friendly GxP applications that are available to purchase or can be created to your exact requirements.

2. Have a process for the 3-releases per year: Every year Salesforce releases new versions in the spring, summer, and winter. Along with these releases come enhancements, fixes, and new features that make the system better than before. These releases are not voluntary and are pushed out on a schedule (check it out here: //trust.salesforce.com). The majority of changes are not GxP, but some are, and require testing and documentation. To best prepare for these releases, you can obtain the release notes as soon as they come out, evaluate each change to determine GxP risk, and then test and document accordingly. Having documentation that is not up to date with the latest Salesforce release will take you out of compliance if there’s a GxP element that YOU haven’t proven to work as expected.

3. Don’t just put your existing process in Salesforce: Taking your as-is process and moving it over to Salesforce without changing anything is easy, but it’s not the best way to go. The fact that you’re selecting a new technology and platform makes it the perfect time to update and optimize your process. Perhaps your process was developed 5-10 years ago, or even a few years ago, and at the time was the best way to do things. Now your business has changed, new guidelines are being enforced, new people and skill sets have entered your organization, and the Salesforce platform has tool and capabilities that you haven’t had access to. Make sure to take the time to identify areas that need improving or can take advantage of additional workflow, collaboration, mobile, and real-time reporting.

4. Start with 1 or 2 GxP processes at a time: Salesforce is powerful and flexible enough to do almost anything or integrate with any other system. The key is to focus on 1 or 2 high priority items such as QMS, doc control, or even just pieces of these larger applications. Configuration of Salesforce can happen quickly but really developing the solution, having the right user-interface development, possible integrations, and training, takes time. Don’t try to do it all at once. For medical device, perhaps start with a product registration process. For clinical, perhaps optimizing sites evaluation. Once you have built and validated a few processes, you can quickly add more and with that, add incredible value and ROI to your organization.

5. Have a centralized governance team for all things Salesforce GxP: The fun thing about Salesforce is once you get those first few apps released, word is going to spread and more users are going to want it for their teams. Because it’s GxP, more rigor is required to properly document requirements, test the end-use, and approve the final product. These can pile up and remain in a “draft-state” if there’s not a team dedicated to their completion. Also with Salesforce, more and more teams and processes are going to be in the same system. This lends itself to sharing common objects and workflow, which requires a team with awareness and visibility to the entire system. Otherwise, you have multiple groups in there duplicating efforts or worse, breaking things or erroneously changing settings that negatively affect other users. Right from the get-go, this governing body or “Center of Salesforce GxP Excellence,” can establish SOPs and maintenance schedules, and create a living, breathing roadmap to bring on new processes and users.Until next time!

 

 

About the Author

Bryan Coddington 85x105 rightBryan 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.

 

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.

 

by Jay Crowley

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As I mentioned in my last post, I believe our goal of a “globally harmonized” approach to UDI appears to be on a path to relative success. Though not our intent in developing the Global Harmonization Task Force (GHTF) and International Medical Device Regulators Forum (IMDRF) UDI guidance documents, the majority of the EU Medical Device Regulations (MDR)/In Vitro Diagnostic Regulations (IVDR) UDI System requirements are literally copied and pasted from the IMDRF guidance document (please send an email to usdm@usdm.com if you would like a copy of the comparison). More importantly, other regulators have also committed to following the principles in these guidance documents. So maybe a word of caution to other regulators: these documents provide “guiding principles” that need to be incorporated into the appropriate regulatory framework. They are not intended to be out-of-the-box regulatory text.

The one area where we do see (necessary) diversion is in the UDI Databases. Each country or regulator manages the regulation of devices differently – and, in many cases, has different (or additional) purposes for UDI. For example, in the US, we are focused on identifying a device through distribution and use to facilitate more accurate adverse event reporting; reducing medical errors; documenting device use in, for example, electronic health records; improving post market surveillance; better recall management; and helping to address counterfeiting and diversion. The EU system is also intended, for example, to “…improve purchasing, waste disposal policies and stock-management by health institutions.” Those needs necessarily require certain (additional) data attributes to be provided.

To “borrow” a phrase from my friend Dennis Black, what we are seeing now is an exponential growth in the data (the “attribute rodeo”) that is required for each UDI Database. For example, although there are 17 data attributes that appear to be common between the Global UDI Database (GUDID) and the European Database of Medical Devices (Eudamed), close to half may need to be provided differently to Eudamed than they are to GUDID. Eudamed also has 10 additional data attributes that are not in GUDID (GUDID has about 15 that are not in Eudamed). Moreover, there are likely to be at least 6 data attributes in Eudamed that will need to be translated (and submitted) into the 24 official languages of the EU. And all that data will need to be created, stored, submitted, updated and managed over the life-cycle of the device. You do the math…

 

 

About the Author

Jay Crowley 6Jay 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.

 

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.

 

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