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.

Digital transformation with Veeva? Choose a Certified Partner that can do it all

Digital transformation with Veeva? Choose a Certified Partner that can do it all

by | Feb 10, 2023 | ECM, Life Sciences, Veeva

Veeva certification: Our annual commitment

Veeva has 3 releases each year, and it’s a requirement that any Veeva partners re-certify each year to ensure 360-degree familiarity with the most recent updates. This is a big commitment for any company to make to support the platform, but it ensures that Veeva implementation and service partners will be able to provide the highest level of knowledge and support for Veeva customers.

To keep up-to-date with the features and opportunities associated with the evolving product suite, fme’s over 30 Certified Professionals maintain their skills and certification with the following courses, and verify their knowledge with final exams that can take an additional three hours to complete.

Vault Platform – Associate White Belt Exam (live lead courses)

  • Vault Platform Fundamentals Pre-work (4 hours)
  • Vault Platform Fundamentals (4 hours)
  • Vault Business Administrator (5 hours)
  • Vault System Administrator (11 hours)
  • Vault Platform Workflow & Security Fundamentals (5 hours)
  • Vault Document Workflow & Security Fundamentals (6 hours)
  • Vault Document Workflow & Security Fundamentals (6 hours)
  • Vault Platform Data Load & Configuration Migration (5 hours)

To extend the validity of the certification, it’s necessary to pass the latest Veeva Release Training and Exam, covering both topics linked to the recent releases and the Veeva Vault Platform as a whole.

Other Life Science-specific Veeva certifications

For a specific Associate White Belt for specific solutions (QualityDocs, QMS, Submissions etc.) there is a Vault Platform Associate White Belt Exam that also needs to be renewed each year.

Vault QualityDocs Associate White Belt

As for the wider Veeva Vault Platform, specific live lead courses need to be completed, including:

  • QualityDocs Fundamentals & Business Administrator (2 + 4 hours)
  • QualityDocs System Administrator (4 hours)

Vault QMS Associate White Belt

  • QMS Fundamentals & Business Administrator (2 + 4 hours)
  • QMS System Administrator (4 hours)
  • Vault RIM Submissions Associate White Belt
    • Submissions Fundamentals (2 hours)
    • RIM Suite Domain Overview Pre-work (3.5 hours)
    • Submission Fundamentals Pre-work (3.5 hours)
    • Submissions Business Administrator (8 hours)
    • Submission Business Administrator Pre-work (5 hours)
    • Submissions System Administrator (8 hours)

Vault RIM Submissions Archive Associate White Belt

  • Submissions Archive Fundamentals (2 hours)
  • RIM Suite Domain Overview Pre-work (3.5 hours)
  • Submissions Archive Business Administrator (4 hours)
  • Submissions Archive System Administrator (4 hours)

fme is your Veeva Certified Partner

Whether you’re implementing Veeva for the first time, or bringing across more content to the platform, fme – a longstanding Veeva Certified Partner for both technology and services – is the ideal choice to manage all your integration and data migration needs. That’s thanks to:

  • Our deep experience. fme was founded in 1995 with a core team of digital transformation experts and has continued to grow to a global presence with offices in Germany, Romania, and the United States of America as well as operations in India. We integrated the Veeva product catalog into our offerings in 2020 and expand our partnership each year.
  • The scale of our resources. We have over 30 Veeva Certified experts working across our client projects at any one time, with a team of experts in OpenText, Generis, and all major platform solutions.
  • Our deep Life Sciences knowledge. We have deep experience with Veeva solutions across all kinds of Life Sciences use cases. We understand your functional and business needs, and have solved many of the most complex challenges in the industry.
  • Our extensive legacy system knowledge. We have in-depth knowledge of the environments that Veeva adopters are moving from, so we have unique insights into how to ensure a migration project achieves its goals the first time, on time, minimizing down-time and workflow interruptions.

Our tested and proven holistic approach, as well as our commitment to an efficient, cost-effective deployment and migration, will decrease your TCO while increasing your technology ROI. We know both the pitfalls and potential of effectively integrated solutions, and can help you plan, implement, migrate and maintain your technology environment. We can also take care of all aspects of business analysis, data validation, data clean-up, and data enrichment – all critical tasks as part of the digital transformation and business accelerating process.

fme’s proprietary migration-center

As service partner, we understand the power and potential of Veeva’s solutions, but the fme team takes it a step farther; we are also a Veeva Technology Partner. To provide the most efficient and error-free transformation to the Veeva platform, we’ve built Veeva natively into our migration-center migration tool. Continually refined over the last 16 years of global migration projects, migration-center is our proprietary tool that allows clients to migrate, consolidate, archive, decommission and flexibly coordinate all of their stored data and documents saving 60% in costs and 80% in project duration, all without impacting daily business operations. It simplifies migration from any platform to Veeva solutions and is not offered by any other provider. Learn more at migration-center.com

Work with the Veeva experts

As a leading Veeva Certified Partner with extensive life sciences experience, fme can help you plan, implement, and migrate to this powerful platform with confidence, speed, and ease. Contact us to get started.

For more information, please complete this contact form and we’ll schedule a time to discuss your Veeva-related challenges and solution options.

Best Partner for RIM and Digital Transformation

Best Partner for RIM and Digital Transformation

by | Feb 8, 2023 | Life Sciences, Technology Services

An extension of your IT team: whenever you need our specialist expertise

Whether you’re a sizeable pharma organization, or a more modest biotech or medical device company, it’s likely that your IT ambitions have grown over recent months. That might be due to a regulatory information system (RIM) implementation or upgrade, or a drive to make data work harder for the wider enterprise.

Certainly, we are seeing updated regulations (such as IDMP and MDR), and a growing emphasis on data generally, translating into more advanced digital transformation initiatives. In many cases, these next-level projects will encompass more than one departmental function and set of integrated IT systems. That’s to ensure that data is unified and consistent right across the organization and its regulatory touch points.

The good news is that fme’s extensive, highly skilled, and deeply experienced Life Sciences technical team is on hand to help.

Our 360-degree perspective is unique

We’re unique in our ability to combine detailed knowledge of all of the major technology platforms with extensive knowledge of digital transformation best practice across Life Sciences.

Deep cross-platform expertise

We’re deeply skilled in integrating, migrating, and enabling the reliable exchange of data across all of the major platforms used in Life Sciences. These range from Veeva, Sparta, Generis CARA, Documentum, Hyland, and Alfresco, to all of the popular manufacturing information systems, accounting/resource management systems (like SAP), chemical systems, health & safety systems, and more.

Across any combination of these platforms, we can help with all of the following:

  • Strategic project planning/roadmapping
  • Application integration
  • Data transformation/conversion & migration
  • Data integration
  • Data validation
  • Experience in complex regulated industries

Even more importantly, we have an unparalleled understanding of the opportunities for amplifying the ROI of complex systems as well as the technical challenges and regulations facing the Life Sciences industry today. This combination of skills gives us a unique perspective for helping companies across the sector realize the benefits of technology efficiently and effectively.

In addition to our in-depth knowledge of the critical success factors of data-driven transformation in the pharma, biotech and medical device sectors, we also bring to bear best practices from other global industries that face similar strict regulations, yet are more advanced in their IT-based solutions. fme manages and supports technical projects across the automotive, chemical, energy, and food industries, supporting and guiding these clients throughout their strategic technical plans and in the practicalities of their integration and data migration initiatives. The rich experience in these additional diverse challenges has allowed us to distill and refine the most effective methodologies to apply strategically in more effective solutions for our Life Sciences clients.

End-to-end services

As an optimally-sized firm, fme has the agility to deliver services from small to large scale. Our global presence is perfectly positioned to provide best-shore teams from our locations across the US, Europe, and India. Sometimes, our clients only need an additional specialist to supplement their own internal IT resources. As they take on new and ambitious system upgrades, consolidations or fuller digital transformation projects, fme efficiently scales resources to match their increasing requirements. This unique technology partnership capability allows us to provide end-to-end services that match our clients’ needs.

Business consulting

If you’re not sure where to start, or are having trouble translating data ambitions into tangible projects and timelines, we can definitely help. This includes building the business case for projects that are often overlooked and difficult to coordinate cross-departmental justification and budgets.

Technology, data, and migration services

As well as becoming more efficient and data driven, most companies are looking to streamline their complex IT estates with the goal of bringing down the total cost of ownership, reduce duplication of effort, and increasing confidence in data as a dependable source of enterprise and regulatory intelligence. The Holy Grail of most data-related projects today is to create a single, connected source of truth: entering data once, and utilizing accurately across all use cases. fme has unparalleled experience in each of these areas, connecting business processes, data and documents in an integrated solution aligned with business goals.

We can also serve as strategic project managers, implementation partners, or at a much earlier stage as consultants and project designers. Our technical subject matter experts can fill specific gaps in capability, or we can do it all – all the while bringing industry and parallel sector experience to bear to maximize project success.

Managed services

We can also support you across and beyond a digital transformation or system integration/consolidation/upgrade project, ensuring the data is and remains as it should be – correct, up to date, high quality, and trustworthy.

Your partner for digital transformation

Our goal for each of clients is to provide the most effective services and support required to support their strategic and technical business goals. We are your partner in waiting for any aspect of:

  • Business consulting
  • Technology services
  • Migration services
  • Managed services

Wherever your needs fall across this spectrum, we’d love to discuss how we can help.

For more information, please complete this contact form and we’ll schedule a time to discuss how we can help you eliminate your challenges, increase your IT ROI, and decrease your system TCO.

DIA RSIDM ’23 in Bethesda, Maryland

DIA RSIDM ’23 in Bethesda, Maryland

by | Jan 16, 2023 | ECM, Events, Life Sciences

Will you be attending DIA RSIDM next month? We’re looking forward to being (safely) back in person to discuss the challenges and opportunities within regulatory information and document management.

Visit us at Booth #202 to discuss recently updated strategies and solutions, the advantages of CSA validation, and to learn more about the meetup on the EDM Structured Submission Reference Model organized by fme’s own David Gwyn. You may have seen him presenting recently on building a more effective and efficient data-centric approach to document management in RIM.

Essential Sessions

If you haven’t reviewed and selected your sessions yet, here are just a few we feel are well-worth the time to attend. Hope to see you there!

Driving Performance from RIM

Enhance your processes to drive ultimate performance from your RIM technology. While describing the road to high performance, the speakers in this session will provide clear examples of regulatory metrics that will demonstrate a high performing RIM technology and how to make the most of country affiliates.

Is It Time to Streamline Your Processes with Structured Content Management?

The current standard processes for document management are no longer sufficient for streamlining submissions or able to support the level of content management, collaboration, and re-use that is possible with the transition from documents to data. This session focuses on practicalities and benefits of structured content management (SCM), including the benefits of transitioning from documents to data-centric processes, and practical use cases and key success factors for SCM.

IDMP Ontology: Semantic Interoperability Throughout the Entire Medicinal Product Lifecycle

This session outlines the implementation challenges of ISO IDMP standards at pharma companies and showcases how an ontology can help achieve semantic interoperability of product data.

How Innovative Collaboration Supports Compliance Across the Regulatory Ecosystem

This session will explore ways sponsors can achieve both greater control and compliance as well as improving their way of working together with health authorities to expand access to medicines.

Visit us at Booth #202

We are excited to participate in these valuable conversations with regulatory thought leaders, and re-connect with industry colleagues! Contact us to schedule a time to talk, or stop by Booth #202 to talk with our solution experts, and share your perspective and questions with the fme team. We look forward to speaking with you!