Join fme at the Veeva Summit: R&D and Quality in Madrid

Join fme at the Veeva Summit: R&D and Quality in Madrid

by | May 2, 2023 | dqMan, Events, Life Sciences, Veeva

Veeva Technology Certified Silver Partner
Veeva Services Alliance Partner Certification Badges with Year 2023_Services
Veeva Services Partner Migration-Certified

The 2023 Veeva Summit: R&D and Quality for clients and partners is fast approaching, and fme has been selected to share our experience and strategies as a Gold sponsor. Only a select group of certified partners are invited to participate, and fme is honored to be recognized as part of this elite group. We cordially invite you to join us to explore how we can work together to leverage the power of the Veeva platform to achieve your business goals.

Proven Success Strategies

The Veeva Conference is a fantastic opportunity to learn about the most effective trends and best practices for content management, network with industry professionals, and engage in insightful discussions. Since fme specializes in the implementation, integration, and support of Veeva content management solutions, we’ll be sharing our experience on how to best configure, utilize, and support Veeva for the unique challenges of your organization.

The Veeva Summit provides unique value to attendees:

  • Gain insights into the latest features and enhancements of Veeva’s content management solutions, how they can help you achieve your IT and business goals.
  • Understand how fme provides tailored IT consulting services to optimize your Veeva solutions, ensuring seamless operation and maximum ROI.
  • Network with other professionals to exchange ideas and learn from their experiences, helping you stay ahead of industry trends and competition.

Join fme at the Veeva Summit or Contact Us Today!

If you attend or not, take full advantage of the Veeva Conference for valuable learning opportunity it provides. Our team of experts will be answering questions, demonstrating our capabilities, and proving how our partnership can bring your organization to new heights. We will also be introducing new offerings that will bring exceptional benefit to our Veeva clients:

  • fme PlatformAssist™ – A comprehensive set of modular building blocks that provide you with the unique end-to-end services needed for carefree post go-live management of your Veeva platform.
  • dqMan – Modeled after our popular dqMan for Documentum, our newest version is focused on the specific requirements of Veeva clients, eliminating time-consuming and repetitive tasks and making admin and data management easy.
  • fme MetatdataAssist™ – Reconnect lost documents without the frustration, time, or costs to your key business resources. Let fme’s life science experts quickly and efficiently update your legacy document’s metadata to ensure they are properly classified and discoverable in your Veeva system.

If you aren’t attending, contact us to schedule a personalized presentation on how fme can provide the end-to-end knowledge and support you need to maximize the value of your information with the Veeva platform.

fme and Veeva Facts

To learn what fme can do as your end-to-end Veeva partner and to get more details on the conference, view our Veeva Summit summary here. To schedule a discovery meeting with fme’s Veeva experts, use the form on the page above, or reach out to me or our Global Sales Director René Rosenberg at r.rosenberg@fme-us.com.

Veeva Summit Details
fme compliance-center solves validation challenges

fme compliance-center solves validation challenges

by | Apr 18, 2023 | Business Consulting, Life Sciences

At last! An end to many of the onerous software validation activities will boost innovation in Life Sciences.

It’s been a long time coming, but a new risk-based approach to computer software assurance looks set to spur new digital advancement in Life Sciences. After a quarter of a century of the rigidly comprehensive Computer Software Validation (CSV) model, in which each and every tweak to an IT system led to a whole raft of testing and documentation, the FDA has published new draft guidance with an emphasis which is more fit for purpose.

Rather than enforce a checklist of no-exceptions tests, the new Computer Software Assurance (CSA) model will be geared to the impact of any changes to a system. It will require new testing and associated documentation only if there is likely to be a direct effect on the product or on patient safety. Indiscriminate testing of logins and similar low-risk processes will no longer be required – or incur the risk of a failed inspection if not completed.

Removing the validation-related barriers to digital transformation

The update to the FDA requirements comes just in time. Over-zealous requirements have caused a reticence to upgrade systems in a Life Sciences Regulatory context because the cost of validation is often two to three times the original cost of the software. While a large company with a sizeable budget and ample internal resources might be able to weather this comfortably, the same hasn’t always been true and cannot always be said for small businesses along the supply chain. Neither size company wants this added cost.

This is one of the reasons Life Sciences has lagged behind other industries in digital innovation. Years ago, analyst firms put the sector at 17th for innovation, a barely altered ranking. If a mundane transactional system had to be put through its paces each time an adjustment was made, consider how much more of a barrier introducing an AI-based capability would have been under the outgoing regime would be.

Although the new approach is still only at a draft guidance stage, the excitement around the change is palpable. Suddenly, even the regulators are pushing for digital innovation in how Life Sciences companies manage their processes, and this impetus for change is now driving the FDA’s new approach to software assurance.

Reducing complexity & cost of validation

The new emphasis on risk-based and ad-hoc software assurance checks and documentation could reduce the time and cost burden by as much as 80%. Instead of resigning themselves to weeks of writing scripts and capturing screens, IT teams will be able to explore the potential for concepts like:

  • AI-based safety signal detection;
  • advanced use of Regulatory intelligence to drive pipeline development and submission strategies;
  • and adopting more innovative interfaces (e.g., voice assistants) to drive complex RIM queries.

At last, companies will be able to reduce their reliance on Excel spreadsheets without worrying about adding to an already overwhelming validation worklist.

Cultivating greater cloud use

Next-level cloud adoption is likely to increase because there won’t be the same requirement to track down and physically visit hosting data centers to check on fire alarms and the like. Instead, third-party assessments will usually be acceptable, opening new opportunities to embrace the latest remote capabilities.

It might be the best part of another year before the new provisions apply, but knowing that the FDA is altering its approach to software assurance paves the way for bolder tech-based ambitions today – whether that’s around AI capabilities or enhanced inter-system data integration.

And fortunately, we’re fme poised to help companies chart and respond to these opportunities. Our new compliance-center™ solution encapsulates the FSA’s new CSA approach in a digital platform, delivering a fit-for-purpose QMS capability for companies in a paperless cloud platform.

Read more about the advantages of CSA over traditional CSV here and keep an eye out for the compliance-center™ webinar in May. We’d be delighted to share more about it – so why not get in touch?

Read more and watch the fme compliance-center™ webinar here

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Learn more about CSV and CSA

Learn more about the challenges and new solutions for software validation in this recording from fme’s David Gwyn. 

About the author

David Gwyn is a strategic, creative, and data-driven Business Development and Technology Specialist with extensive expertise in building key partnerships, implementing business strategies, and deploying solutions across the life science and emerging technology industries. In October 2021 he joined fme US as the Business Unit Director for Business Consulting. For the past 30 years, he has led teams in the delivery of content management, clinical, and quality solutions with a recent focus on end-to-end Regulatory Information Management (RIM). His practice has evolved in parallel to the Life Sciences industry, moving from custom-developed software solutions to packaged-based implementations, and the development of methodologies and best practices to guide practitioners in realizing the greatest return on investment. Mr. Gwyn is passionate about helping organizations evolve from traditional to digital businesses and increase their ability to act with speed and agility.

Smoothing the road to RIM transformation with Veeva

Smoothing the road to RIM transformation with Veeva

by | Apr 12, 2023 | Life Sciences, Migration Services, Veeva

Putting data integrity first in digital transformation

So much of the value of pharma R&D companies is in the data they produce and own. Yet when embarking on digital transformation programs – such as regulatory information management (RIM) migrations using a modern platform such as Veeva – many organizations overlook the work that will be involved in preparing legacy data so that it can be used optimally and confidently in the new system.

As many terabytes of information are moved across to the new platform, very real challenges around that data’s quality, integrity, completeness, and fitness for future purpose can arise. And unless these issues are addressed ahead of or as part of the migration, the new platform will never be able to deliver to its full potential.

Making smooth work of data migration for a mid-sized global pharma R&D company

In a recent client project that I worked on with Veeva and data migration specialists fme, the need for foundational data work was recognized and provided for up front. This had a direct bearing on the successful implementation and outcomes of the new Veeva RIM system.

The company, a global, mid-sized pharma organization, was embarking on a major international program to modernize its Regulatory documentation and submission management capability, which would require extensive content mapping and data enrichment.

fme brought immediate value here, able to fill gaps in the client’s internal knowledge. For instance, fme had expert knowledge of the target Veeva system, being a certified Veeva partner, and of the scope of the data clean-up, preparation, augmentation/enrichment, and validation that would be required.

Containing any risk with the fme migration-center

Crucially, fme was able to call into play its migration-center. This is its own proprietary platform for high-volume and complex content migration. The fme migration-center allows all the data verification and preparation work to happen in a ‘safe’, validated environment without disrupting the primary, live Regulatory Affairs system. The dedicated toolkit takes care of all the translation work by working on a series of ‘deltas’ – for example, starting with historical and fairly static records, then progressing to data that is still changing. This carefully honed process for data extraction plays an important role the minimizing risk of large-scale data migration work.

fme’s tools and experience reduced migration time by a third

The result of all this meticulous work, the vast majority of which was able to happen safely offline, was that the total migration took just 12 months – a whole six months faster than anything I have experienced previously in my two decades of large system implementations. Certainly nothing so comprehensive, involving such vast volumes of data and such extensive data translation and augmentation. The speed was quite phenomenal.

Importantly, it isn’t just the level of technical expertise that fme brings to such projects that sets the company apart. It’s also the consultants’ knowledge of Regulatory processes and data in Life Sciences, and their ability to bridge technical and business teams in getting across what needs to be done.

A certified partnership

As I said at the outset, data is probably THE most valuable asset a pharma R&D company possesses, so upholding its integrity and securing its long-term potential is absolutely critical.

For the global client, the new global Veeva system went live as planned and was hugely successful. It is one of many data migration projects fme has worked on with Veeva, whose platform today is the industry standard in Life Sciences for RIM modernization.

One of the hallmarks of fme’s work is the close relationship its consultants form – with Veeva, with the client, and with any other consultants who may be involved (in this case, me). Nothing is ever ‘thrown over the fence’; ownership of the project success is very much shared and respected.

I now work regularly with the specialist team at fme and, thanks to the meticulous planning and attention to detail which comes from such deep experience and subject matter expertise, our projects are among the smoothest I have ever witnessed.

Get started, risk free

Don’t let your migration start off down the wrong path. Set the right direction by taking advantage of a free 30-minute analysis with our Life Sciences expert and Business Unit Director, Ian Crone. His unique combination of sector understanding and technological knowledge give him an unparalleled perspective on the possibilities and pitfalls inherent in complex transformation initiatives in this complex and highly regulated industry.

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About the author

Guest author Jon Sanford is an independent regulatory/RIM expert at Rubus Ilex. He has worked in the field of Regulatory Operations for two decades and has over 30 years’ pharmaceutical experience, which has included managing a team of Regulatory Operation professionals responsible for publishing regulatory dossiers across Europe and Asia and Latin America. He has also been the business lead on a number of Global Document Management Systems, Regulatory Publishing Systems and RIM implementations.

Migration strategy and the path to operational resilience

Migration strategy and the path to operational resilience

by | Apr 6, 2023 | Content Migration, Life Sciences, Migration Services

Over the past few years, an effective digital transformation has been underscored emphatically as a prerequisite for long term business success. Complacency around operational and digital resilience now represents a legitimate existential threat to enterprises in any industry, both from a competitiveness and regulatory compliance perspective.

At its core, digital operational resilience describes an enterprise’s ability to mitigate the risk of spontaneous server outages, rapidly recover from service interruptions and maintain a bird’s eye view of potential systems vulnerabilities. Upgrading to modern solutions and maintaining legacy data in those solutions with an effective data migration strategy is an important aspect of robust digital resilience strategies. This article introduces the importance of an effective migration strategy within a digital transformation process, the approaches being adopted by industry leaders, and best-in-class examples that can accelerate business value.

The link between data migration and regulatory compliance

While data migration has become an integral process in the digital transformation game, it is often overlooked as a core facet of regulatory compliance. Botched or poorly executed data migrations can be catastrophic from an operational point of view – leading to data loss, data corruption and unnecessary downtime – and can also incur heavy regulatory sanctions. If personal data is lost or compromised during a migration, it can result in legal and financial penalties, reputational damage, and loss of customer trust. For example, if a company can’t produce the required documentation for review and approval, it can impede drug certification and undercut revenue.

To add to the challenges, public discourse around data privacy has intensified over the past few years, with new frameworks being implemented to protect users’ Personally Identifiable Information (PII): General Data Protection Regulation (GDPR), the California Consumer Privacy Act (CCPA) and the Data Protection Shield are just some of the regulatory initiatives designed to safeguard user data in recent years. This new regulatory minefield has forced enterprises to rigorously assess their processes for handling and storing user data and has amplified the case for robust data migration strategies when integrating new systems and combining data in corporate merger processes. It is essential that data is held securely and that the processes for protecting that data fit snugly within regulatory parameters. Effectively planning a migration to a new system can also enhance data security, while also ensuring that the data is accessible for deletion in accordance with GDPR stipulations. Additionally, enhanced data control and security can greatly mitigate the risk of data breaches and associated regulatory penalties.

According to a 2022 survey by digital infrastructure company Equinix, complying with data regulations was a top priority within the technology strategies for 87% of US organizations’, with 83% acknowledging IT infrastructure migration to the cloud as a top priority. The groundswell of momentum powering enterprises’ migration to cloud based servers from on-prem physical servers shows no signs of slowing down. We believe that innovative data migration technology will be a key component of successful digital transformations to advanced technologies. Luckily for businesses today, the development of advanced data migration technology is bringing more transparency into the data migration process with an established content migration tool, giving enterprises a diverse set of tools to choose from to ensure they are well equipped to thrive in today’s frenetic digital environment

Trust proven, consistent experts

The often-ignored truth is that data migration is a complex endeavor that touches multiple departments and roles that need to coordinate tasks, requirements, and timelines. By leveraging innovation partners with demonstrable expertise in the data migration arena just like our Migration Services team, companies can now navigate the migration journey with a greater sense of confidence. To be successful, migration experts and implementation consultants of the target system should have a common understanding of the business objectives. In an ideal scenario, consultants should be available for the entire duration of the project, to ensure consistency of service delivery. Rotating personnel on the project might incur delays as they will need to be briefed thoroughly on the progress or could lead to impaired decision making that doesn’t fully factor in legacy efforts.

Understand your ‘why’

Organizations undertake data migration for a variety of reasons, such as strengthening system security, enhancing customer service capabilities, or driving operational efficiencies. Perhaps a streamlined platform is being implemented to support different business processes, establish a new data warehouse, or merge new data from other sources.

Before any prospective migration program is initiated, there must be a consensus and unified vision from leadership around the desired outcome and goals of the initiative. Irrespective of the initial rationale, the end goal is to have streams of up-to-the minute and accurate data sets which can enable businesses to personalize their services and boost customer retention, while developing a more nuanced understanding of key demographics. In both instances, data should be in the system, either the master data or all relevant registration objects.

In future articles, we will discuss key steps for the preparation phase, and what core considerations should be made before project initiation.

Conclusion and next steps

Whatever the reason for the data migration, the goal of all stakeholders is to provide a solution to the business in order to improve business performance and ensure competitive advantage. To achieve this, they should give more attention to data migration and be smarter in the assessment, planning, and migrating data with experts that have experience and knows the business in the life science industry.

fme has been guiding global pharmaceutical and manufacturing firms through their complex migration journeys for over 20 years. We’ve even developed our own proprietary tool migration-center to enable seamless migrations with minimal downtime. Contact us to discuss your challenges and start your journey on the right path.

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IDMP Advisory Update: The latest on DADI-based EMA submissions

IDMP Advisory Update: The latest on DADI-based EMA submissions

by | Mar 29, 2023 | Life Sciences

The Identification of Medicinal Products (IDMP) is a set of global standards for the identification and description of medicinal products developed by the International Organization for Standardization (ISO). It facilitates information exchange between regulatory authorities, pharmaceutical companies, and other stakeholders in the healthcare industry to improve patient safety.

The official launch date for the standard has not been defined, and the expected dates have shifted several times in the past years. The short guide below recaps the latest advice on important milestones and deadlines, and offers a useful action plan as companies strive to make their data-first regulatory initiatives count – both now and for the longer term.

“This information was reviewed and valid in Q4-2022. Due to EMA’s agile development approach there may be additional updates or changes. Please contact us to discuss how the most recent changes impact you.”

IDMP in Europe and the US

The European Medicines Agency (EMA) has mandated the use of IDMP for pharmaceutical companies operating in the European Union (EU) by 1 July 2022. That date has been revised, and as of this writing an official launch date has not been defined–the expected dates have also shifted several times. This has relieved some of the immediate pressure on pharmaceutical companies adapting existing systems and data as it takes a significant investment of time and resources to implement the standard.

The US Food and Drug Administration (FDA) has proposed the use of IDMP, but implementation dates are yet to be determined. fme recommends that all pharmaceutical companies across the globe be prepared to comply with the IDMP standard as it continues to increase in acceptance.

In this paper

After the most recent updates to EMA requirements, fme put together a summary and handy action plan to help guide Life Sciences companies toward the most effective and efficient system migration. In this eBook we’ve included:

• DADI Human Form Timeline
• A summary of how the latest developments could affect you
• Elements of the requirement that have not yet been defined
• 4 benefits of IDMP to exploit
• 5 things pharmaceutical companies should do next

Moving forward with IDMP

The latest guidance encourages all Life Science companies to become more data-centric in their mindsets and everyday activities to become more efficient and effective. Any foundational digital transformation work done now will ensure companies are well positioned when other regions across the world implement their own approach to IDMP.

Don’t fall behind. Download fme’s IDMP Advisory Update eBook now, and ensure that your team stays aligned with the coming requirements.

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Digital transformation is about more than technology

Digital transformation is about more than technology

by | Mar 7, 2023 | ECM, Life Sciences, Technology Services

Applying Life Sciences best practices for business success

Today, competitive life sciences companies are looking to transform their everyday operational processes. Through strategic use of modern technology, their goal and absolute requirement to stay competitive is to manage workloads more efficiently and consistently for better business outcomes. In these complex businesses, it’s critical to approach this transformation from both the technology perspective as well as the holistic business perspective. This holistic view can make a profound difference to project outcomes, delivering the most business impact and ROI on technology investments.

Twelve years of experience working with clients on exactly this potential has provided fme consultants with a unique ability to help here. We understand the business processes and know first-hand how all the technology fits together to provide optimal workflows and solutions. Our experience goes beyond immediate critical areas like Regulatory Affairs, and extends across different business units to amplify the value of complex data, documents, and information.

Here’s a brief overview of one of our typical engagements. Read the information below and contact us for more details, and to discuss your current challenges.

Long term relationships for long term success

We first connected with one of our long-term clients over a decade ago. As a successful international pharmaceutical firm, they had many divisions and business units integrated through a complex network of systems, servers and silos that shared, shuffled and sorted a plethora of data and documents around the globe. The scope of our initial technical engagement was to maintain servers and associated processes, which we were able to provide quite well.

As we worked together on this first engagement, the fme team was able to get a deeper understanding of the content, tasks, goals, and strategies that were being used across different business units. Our goal wasn’t myopically focused on deploying systems, or even the larger task of integrating them and migrating data from legacy environments. Based on our extensive industry experience, we took a holistic view, discerning how those systems could be used more efficiently. We saw how their information was being applied throughout the company, and presented a range of opportunities to streamline and simplify the way those tasks were being completed day to day. Our client was overwhelmed with our initiative, and opened up several more projects. In one instance, we were able to reconfigure a system so users around the world can log onto a controlled environment and fill out the relevant training information in just a few minutes, without any to-ing and fro-ing of queries. Processes that once took 30 minutes or more per request can now be completed via self-service in a fraction of that time.

With successes like these, our relationship quickly expanded and evolved with many additional business units. We’ve been able to improve in areas ranging from the generation of reports and overviews, and the digitalization of manual processes, to the reinvention of training and associated administration, and much more. In another recent project, we analyzed business processes and assessed the scope for digital transformation using the Microsoft Power Platform, including the central recording of data around business documentation and training. Our peak projects there have seen us field 15-20 technical consultants globally, plus two on the business side, providing a seamless interface between the business departments and the technical teams.

Today, we continue to be a prominent digital partner, continuing to help streamline daily activities as well as plan and execute larger long-term initiatives.

fme is the company you love to work with

The reason clients like this love to work with fme is our unique experience and insights from successful digital transformations in a wide range of companies and industries. In addition, the rapport we build with our clients is pivotal. We’re open, approachable, and visible to the business and technical teams we work with, and they feel comfortable talking to us. The client team knows that if they are under-resourced/have particular knowledge gaps, we’re ready to step in. Where required, we can take over as a project lead or manager too, overseeing the interconnections between different processes and the scope for higher-level thinking.

We have a broad spectrum of knowledge, and can always find the answer to a challenge even if that resolution if outside of the current project. We’re specialists not just in system implementation and content migration, but also in how to transport legacy processes to a new digital set-up, where workloads can be refined and optimized. Our engagements span quality management, standard operating procedure (SOP) management, regulated/submissions documents, clinical trial administration, and training SOPs, and more.

If you’re struggling to progress your own digital transformation ambitions, why not have a coffee with us and we can talk through the various ways we might be able to help?

For more information, please complete this contact form and we’ll schedule a time to discuss your specific requirements.