Modernization, Transformation and Data Migration with Steve Gens

Modernization, Transformation and Data Migration with Steve Gens

by | Jan 30, 2025 | Digital Transformation, ECM, Life Sciences, Migration Services

This month, fme’s President Frank D’Entrone joined the Regulatory Executive Podcast with Steve Gens. We’ve worked with Steve for many years and have been recognized in Gens & Associates industry studies as a leader in the migration services provider category. Listen to the Gens & Associates Regulatory Executive Podcast >>

Listen to the Podcast

Frank was honored to be invited to sit down to discuss the trends and challenges of modernizing large RIM, Quality and Clinical systems, and how to plan an efficient, accurate and compliant data migration. From our experience with clients from small pharmaceuticals up to the Top 20 firms, many start a modernization or transformation initiative without a clear understanding of the quality and state of their existing data and documents. This is a critical phase of any migration that should not be skipped or minimized. Done correctly, it can have a powerful influence on the success of the transformation initiative by revealing the level of data remediation required, how much can be automated, and how much requires human involvement.

We highly recommend you take the time to listen to Frank and Steve’s discussion. They cover:

  • fme’s history, reputation and focus
  • Importance of data remediation in a migration initiative
  • Value of a ‘Phase 0’ focused on evaluating existing data and documents
  • Proven and evolving automation tools like AI
  • Industry trends and challenges
  • fme’s future vision

The Bottom Line on Data Migrations and Digital Transformations

The bottom line is today’s advanced digital tools – traditional, AI-powered, or otherwise – all depend on organized, accessible and compliant data. After almost 30 years of experience, fme understands how to apply our proven methodologies and migration tools with evolving AI and NLM capabilities for successful migrations, ensuring our clients get the most ROI from their technology investment. Regardless of source and target systems, fme’s experts know the most effective ways to clearly define the system’s current state and help client’s plan an efficient path into the future. Contact us to get started.

We hope you find Frank and Steve’s discussion enlightening and useful. If after listening you have any questions or comments you’d like to share, send us a message – we’d love to get your perspective, and learn more about your current challenges.

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fme Earns Veeva Services Partner Re-Certification for 2025

fme Earns Veeva Services Partner Re-Certification for 2025

by | Jan 9, 2025 | Life Sciences, Press, Veeva

FOR IMMEDIATE RELEASE

fme Earns Veeva Services Partner Re-Certification on Veeva Development Cloud, Demonstrating Continued Commitment to Life Sciences Innovation 

DANBURY, CT – Jan. 7, 2024 – fme, a global leader in data and document migration, enterprise content management, and business consulting services, proudly announces its renewed Service Partner Re-certification for Veeva Development Cloud. fme is also a Veeva Product Partner for its migration-center product which carries out automated, large volume migrations without system downtime. The combination of these achievements underscores fme’s dedication to supporting life sciences organizations in their digital transformation journeys and ensuring excellence in migration services.

Meghan Carr, Vice President of Technical Services at fme, highlighted the importance of this milestone: “We are excited to share our continued commitment to supporting innovative life sciences organizations that are standardizing on the Veeva Vault Platform. Supporting global digital transformations with our team of experts across multiple Veeva Vault domains is a key focus for fme. We are proud to be part of such remarkable partner programs, working alongside Veeva to focus on client success.”

Frank D’Entrone, President of fme US and migration subject matter expert, emphasized the significance of this achievement: “Our re-certification reflects the confidence our clients place in us to deliver on complex migration workstreams with critical timelines. It demonstrates our ongoing investment in ensuring our migration consultants possess the highest level of expertise to meet the challenges of an evolving industry. This milestone reinforces fme’s position as a trusted partner for global life sciences organizations undertaking transformational programs.”

The renewal of this certification strengthens fme’s position as a trusted partner in helping life sciences organizations leverage the Veeva Vault Platform for their regulatory, clinical, and quality management needs. fme’s expertise ensures clients can confidently navigate complex migration challenges while achieving their strategic objectives.

For more information about fme’s services and partnership with Veeva, please visit fme-LifeSciences.com.

About fme

fme specializes in delivering tailored business solutions for the life sciences industry, with a focus on data and document migration, enterprise content management, and business consulting.

Deep Dive into Regulatory Solutions at DIA RSIDM 2025

Deep Dive into Regulatory Solutions at DIA RSIDM 2025

by | Jan 6, 2025 | Business Consulting, Events, Migration Services, Regulatory

This February, DIA RSIDM 2025 returns to Bethesda, MD, reaffirming its reputation as the premier event for regulatory professionals to exchange the best solutions for managing complex regulatory submissions. At fme, we specialize in helping pharmaceutical and biotechnology companies navigate regulatory challenges with expertise in selecting, planning, and migrating to RIM solutions tailored to their unique data, documents, and workflows. Visit us at Booth #315 during the RSIDM forum—we’d love to discuss your challenges and plans for 2025!

Operational Efficiency is Critical

Every day, pharmaceutical companies strive to demonstrate the efficacy of new discoveries and deliver life-changing medications to patients in need. To accelerate time-to-market and ensure safety, timely and high-quality regulatory submissions to health authorities are critical for review and approval.

However, the process is fraught with challenges. The sheer volume and complexity of data, documents, and information exchanged among multiple stakeholders and systems create significant hurdles in maintaining accurate, up-to-date documentation. Errors, omissions, or inconsistencies can lead to costly delays and disrupt expected release timelines.

Seasoned regulatory professionals recognize the importance of operational efficiency in managing regulatory information effectively throughout the development cycle, ensuring smooth and successful submissions.

Keys to RSIDM Efficiency and Success

Efficiency and success in regulatory operations depend on seamlessly aligning people, processes, and technology throughout a medication’s journey—from conception to patient use. With years of experience and a proven track record, fme has gained deep insights into the complexities of every phase of this journey. This expertise has enabled us to develop and refine methodologies that:

  • Analyze existing systems and workflows
  • Align requirements with tailored technology solutions
  • Ensure data and documents are accurately classified for discovery and use

fme’s experts combine a deep understanding of the product development lifecycle with extensive experience in regulatory projects. Staying ahead of evolving data standards, requirements, and technology trends, we guide clients toward the best solutions for today while future-proofing their decisions to deliver long-term ROI.

Download this overview to see how fme can help you achieve regulatory excellence and why we are recognized as a leader in content management solutions for regulatory environments.

Download Overview

Connect with fme at DIA RSIDM 2025

Last year, fme’s David Gwyn spoke on “Leveraging Structured Content Authoring in Regulatory Submissions: Real-World Experience, Industry Insights and Tools.” This presentation focused on the latest EDM Structured Reference Model team developments, showcasing how their work influences industry-wide adoption. For more information, view the full details of the session here.

For 2025, David will be joined by RIM experts Jonathan Byars and Frank D’Entrone to provide their expertise on effective strategies to align people, processes, and technology for RIM success. fme’s experience across platforms, industries, and global territories gives us unparalleled insights into the best strategies and solutions and how to ensure a successful journey to regulatory excellence.

What are your challenges for 2025? Use the form below to request a no-cost discovery session and we’ll schedule a time to discuss your concerns and possible solutions. If you are attending RSIDM 2025, join us at Booth #315 and we can start the conversation in person! If you can’t attend this year, download the overview and let us know if you’d like to talk.

Contact us

The DIA RSIDM 2025 Educational Tracks

The educational tracks for this year’s conference reflect the continued integrated communication challenges regulatory professionals face within a quickly evolving technology landscape. Download the overview above to learn more about how we can support your team in each.

  • Track 1: Building and Sustaining Successful RSIDM Foundations
    • This track is designed for attendees who are either new to the field or seek a comprehensive review of the evolving dynamics and intricacies that shape their day-to-day work.
  • Track 2: Optimizing Processes and Procedures
    • This track is tailored for intermediate-level professionals and focuses on what is needed to improve processes, procedures, and data to foster a culture of innovative practices and forward-thinking. Learn proven industry best practices and discuss the impact of new global regulations on your organization’s processes and procedures.
  • Track 3: Adopting Innovative Technologies
    • This intermediate to advanced track provides first-hand knowledge from global regulatory health authorities on the implementation of new technologies, policies, and guidelines. It also includes perspectives on how to incorporate technology advancements like artificial intelligence and automation, and how to assess their effectiveness and impact.
  • Track 4: Achieving Regulatory Excellence
    • This advanced track is designed for leadership roles, and includes examples and use cases from organizations that have achieved regulatory excellence. It covers a wide range of practical implementation strategies to support vision, cultural change, and commitment to innovation.

We are excited to participate in these valuable conversations with regulatory thought leaders and re-connect with industry colleagues! Find the full RSIDM 2025 agenda here, and contact us if you have any questions about the specific tracks or sessions offered. We look forward to seeing you there!

1 Step 1

Solve your regulatory challenges. 

fme has clear methodologies to stay ahead of quickly evolving data standards, complex requirements and changing technology options. Learn the first steps and get started today. 

Download Regulatory Excellence Overview
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Join fme in Boston at the Veeva Summit: R&D and Quality

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

by | Aug 19, 2024 | Content Migration, Events, Life Sciences, Migration Services, Technology Services, Veeva

The 2024 Veeva Summit: R&D and Quality is in Boston in a few weeks and fme is honored to be one of the few certified partners to have been selected as a Gold sponsor. We look forward to sharing our experience and strategies with the Veeva community again this year. We cordially invite you to join us to network, share strategies and learn more about the capabilities of the Veeva platform.

Veeva Summit

With over 2,000 life science industry professionals attending, the Veeva Summit in Boston is the best place to get first-hand details on today’s most effective R&D and Quality strategies and solutions for content management. fme is a certified partner supporting the Veeva platform for Life Sciences firms through selection, migration and maintenance, so we’ll be sharing our proven methodologies to best configure, utilize, and support this powerful platform and leverage its capabilities to achieve business goals.

Each year, the Veeva Summit deliver unique value to attendees:

  • Gain insights into the latest features and enhancements within Veeva’s powerful platform, and how it can help you achieve your business goals.
  • Understand how fme can help plan and optimize your Veeva environment, ensuring seamless integration, operation, and maximum ROI.
  • Exchange ideas, network, and learn from industry professionals to help you stay ahead of industry trends and competition.

Why Migrate to Veeva Vault?

Throughout the Veeva Summit, clients and partners will be sharing their knowledge and strategies for planning, integrating, utilizing and maintaining the platform. Veeva Vault offers a unified suite of applications designed to manage the critical content and data in life sciences. By centralizing information across quality, regulatory, and clinical operations, Veeva Vault enhances collaboration, improves compliance, and accelerates time to market. However, the migration to such a robust system is not without its challenges. Moving large volumes of data from legacy systems, databases, and various content repositories requires expertise, precision, and a deep understanding of the unique needs of the life sciences industry.

fme at Veeva Summit

With decades of experience in the life sciences sector, fme has established itself as a leader in data and document migration services and is your trusted partner for Veeva Vault migrations. Drawing on my personal experience in migrating legacy data and documents, I understand firsthand the challenges clients face—from navigating complex regulatory requirements to ensuring data accuracy and integrity throughout the migration process. This insight drives our commitment to making your migration to Veeva Vault as seamless as possible.

Industry Expertise That Sets Us Apart

At fme, we bring extensive experience in the life sciences industry to every migration project. Having personally worked on numerous migrations, I know fme’s expert team understands the intricate challenges that come with moving critical data and documents. Our team have extensive knowledge of the stringent regulatory requirements that govern the industry, including GxP compliance, and we ensure that every step of the migration process meets these standards. Our expertise spans quality management, regulatory affairs, and clinical operations, making us uniquely qualified to handle the nuanced needs of your migration to Veeva Vault.

Comprehensive Migration Services

Our migration services are comprehensive, covering every phase of the migration journey. We start by thoroughly assessing your existing systems and data to understand the migration scope and identify potential challenges. Leveraging our many years of migration experience, we collaborate with you to create a migration plan that aligns with your business objectives and addresses concerns upfront. We then meticulously map your data to the Veeva Vault structure, ensuring all necessary transformations are applied for accuracy and readiness. Utilizing our specialized tool, migration-center, we handle the extraction, transformation, and loading of data from various source systems into Veeva Vault, with rigorous validation processes to meet all regulatory requirements. Post-migration, we provide ongoing support to ensure your Veeva Vault environment functions smoothly, offering training, troubleshooting, and customization as needed, backed by my experience in anticipating and resolving issues.

migration-center: The Power Behind Our Migrations.

migration-center, our purpose-built migration tool, is designed to simplify even the most complex migrations. Capable of supporting over 250 source-to-target system combinations, migration-center seamlessly handles content extraction and migration to Veeva Vault from databases, file shares, cloud platforms, and legacy applications. This flexibility ensures that no matter where your data currently resides, we can migrate it efficiently and accurately to Veeva Vault.

Tailored Solutions for Unique Needs

We understand that every organization is different, with unique challenges and requirements. That’s why we don’t take a one-size-fits-all approach. Having personally navigated various migration scenarios, I know how important it is to tailor our services to meet your specific needs. Whether you’re migrating a small dataset or a complex array of content types, we have the expertise and tools to deliver a solution that works for you.

A Commitment to Compliance and Quality

In the life sciences industry, compliance isn’t optional—it’s essential. We are experts in ensuring that your migration process adheres to the strictest regulatory standards. From GxP compliance to meticulous documentation, we leave nothing to chance. Our team works closely with your quality assurance teams to validate every aspect of the migration, giving you peace of mind that your data is accurate, complete, and ready for regulatory scrutiny.

Why Choose fme for Your Veeva Vault Migration?

Migrating to Veeva Vault is a significant undertaking, but with fme as your partner, it doesn’t have to be daunting. We combine deep industry knowledge, cutting-edge tools, and a client-centric approach to deliver migration services that are seamless, secure, and compliant. My personal experience in the life sciences industry has equipped me with the insights necessary to anticipate challenges and guide you through a successful migration.

Contact Us Today!

Ready to make the move to Veeva Vault? Contact us today to learn how fme can support your migration and help you unlock the full potential of your content management system. We’ll schedule a discovery meeting with our Veeva experts to discuss your current challenges and introduce the range of possibilities and next steps to accelerate your journey to success.

Contact Us

Not Attending Veeva Summit?

Not attending the Veeva Summit in Boston this year? That’s an even better reason to contact us to schedule a personalized presentation. We’ll share the newest updates and announcements from Veeva, and discuss solutions for your short- and long-term challenges.

Transforming Your Quality Management System Selection with SelectAssist℠

Transforming Your Quality Management System Selection with SelectAssist℠

by | Aug 14, 2024 | Business Consulting, Datasheet, Life Sciences, Quality

Navigating the complexities of selecting the right Quality Management System (QMS) and Quality Document Management System (QDMS) can be daunting, especially for Life Sciences companies. These industries are highly regulated and require specialized software solutions to manage intricate processes and extensive documentation. You’re not alone if you’re feeling overwhelmed by the selection process. This is where SelectAssist steps in to simplify the journey and ensure you make a choice that supports your current and future needs.

What is SelectAssist?

SelectAssist is a specialized methodology designed specifically for life sciences companies to streamline the QMS and QDMS solutions selection process. Choosing the right software is more than just ticking boxes; it’s about ensuring the solution integrates seamlessly with your existing systems and meets your business’s critical needs.

At the core of our approach is the belief that stakeholder involvement is paramount. Engaging key stakeholders throughout the decision-making process not only promotes higher adoption rates but also significantly enhances the success of the implementation. By listening to the voices that matter most—your end-users—we tailor the selection process to ensure that your chosen software solution is the best fit for your organization. Download our datasheet for specific details >>

The Challenges You Face

Life Sciences companies face unique challenges when selecting software due to the sector’s highly regulated nature. Compliance with multiple quality standards, the need to manage vast amounts of documentation, and the necessity of integrating new solutions with existing software stacks are just a few of the hurdles that must be overcome.

Moreover, understanding the end-to-end quality management experience is crucial to minimizing manual activities and maximizing efficiency. The selection process can be time-consuming, costly, and risky without a methodology that considers these factors.

How SelectAssist Solves These Challenges

SelectAssist addresses these challenges head-on with a comprehensive, industry-tailored approach. Our methodology prioritizes understanding your quality and document management requirements while ensuring seamless integration with your current systems. We focus on both the technical fit and the critical business needs, providing a balanced view that encompasses technical capabilities, financial stability, and the vendor’s commitment to future development.

Our approach begins with involving critical stakeholders from the outset. By incorporating their insights and needs, we ensure the selected software aligns with user expectations and organizational goals. This inclusive decision-making process fosters ownership and ensures higher adoption rates and successful implementation.

The Integration Advantage

An integrated QMS and QDMS offer significant advantages. When your QMS is tightly coupled with your QDMS, you gain enhanced compliance, improved efficiency, greater visibility, and enhanced collaboration. Documents supporting quality processes are directly tied to the processes themselves, providing a comprehensive solution that streamlines operations and effectively meets regulatory requirements.

Our Comprehensive Offering

The SelectAssistSM process is designed to support every stage of the software selection process. From developing a business case and executing a Request for Information (RFI) process to evaluating proposals through scripted demos and Software Verification Workshops (SVWs), we ensure a thorough and informed decision-making process.

Our methodology also includes a future-state assessment of potential vendors, evaluating their commitment to innovation and customer success. This thorough vetting process ensures that the chosen vendor is technically capable and aligned with your organization’s long-term goals.

Benefits You Can Expect

  • Tailored Fit: Aligns QMS and QDMS solutions with your strategic objectives while accommodating your unique regulatory compliance needs.
  • Seamless Integration: Identifies early integration requirements to ensure a smooth user experience.
  • Engaged Stakeholders: Fosters ownership and acceptance among end-users through inclusive decision-making.
  • Balanced Insights: Combines technical capabilities with broader business impacts for well-rounded decisions.
  • Future-proof Solutions: Ensures the software can adapt to regulatory changes and business growth.

Discover More about SelectAssist

Are you ready to transform your QMS and QDMS selection process? Download the datasheet below and contact us to learn how SelectAssist can provide the clarity and confidence you need to make the right choice for your organization. Don’t leave your software selection to chance—let SelectAssist guide you to the solution that fits your needs today and tomorrow.

Download Datasheet
1 Step 1

Solve your QMS challenges. 

fme has clear methodologies to stay ahead of quickly evolving data standards, complex requirements and changing technology options. Learn the first steps and get started today. 

Download the datasheet
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Why Choose fme?

Our approach is distinguished by our emphasis on understanding the technological and human factors involved in QMS and QDMS package selection. Successful implementation is not just about the software; it’s about aligning with people’s work, integrating into existing systems, and adapting to future changes. With fme, you’re not just choosing a service provider; you’re choosing a partner committed to ensuring your solution is a resounding success. Contact us today to get started.

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Navigating the Maze of Regulatory Information Management (RIM) Package Selection: The fme Approach

Navigating the Maze of Regulatory Information Management (RIM) Package Selection: The fme Approach

by | May 31, 2024 | Business Consulting, Datasheet, Life Sciences, Regulatory

Regulatory Information Management (RIM) remains critical in today’s ever-evolving pharmaceutical industry. It involves maintaining licensure across countries and publishing the necessary information for health authority approvals. Selecting the right RIM package isn’t just about integrating technology; it’s about ensuring the solution meets complex business requirements and gains widespread user acceptance. This is where fme steps in, employing a meticulous approach to guide companies through the RIM package selection and evaluation process.

1. Understanding the Complexity of RIM

Regulatory Information Management manages and publishes licensure information across multiple countries. As such, purpose-built solutions tailored to these unique demands are required. fme recognizes this need and offers services that understand the intricacies of RIM and the integration challenges with existing software stacks.

2. fme’s Approach to Software Selection

fme’s approach is characterized by a systematic methodology designed to capture both current and future requirements of RIM and publishing. Here’s how we do it:

  • Define Requirements: Before proceeding with solution selection, we work closely with clients to define their current and future RIM requirements, ensuring that any solution aligns with their business objectives.
  • Identify Candidate Solutions: Leveraging our industry expertise, we identify potential solutions that could integrate well with the client’s existing software stack.
  • Drive Evaluation and Selection: Through a series of evaluations, we ensure that all critical voices from the user community are heard, ensuring that the solution meets technical requirements plus user needs and preferences.
  • Support Decision Making: We assist clients in the final decision-making using quantitative and qualitative measures to compare potential solutions.

3. Engaging Key Client Team Members

A unique aspect of our approach is the emphasis on stakeholder engagement. We understand that for any solution to be successfully adopted, it must receive widespread acceptance from its end-users. Therefore, we:

  • Organize Requirement Gathering Sessions: We facilitate sessions with various stakeholder groups to ensure all needs and concerns are captured.
  • Promote Participation in the Selection Process: From defining requirements to evaluating demos and participating in hands-on pilot tests, we ensure key client team members are actively involved in every step.

4. Ensuring a Tailored Fit

Our methodology doesn’t just stop at selecting a package; it ensures the solution is tailored to the client’s organization. This includes:

  • Building the Business Case: We help clients articulate the strategic objectives and analyze financial implications, ensuring the solution delivers value.
  • Narrowing Down Vendors through RFI/RFP Processes: We ensure that only the most suitable vendors are considered through a structured RFI and RFP process.
  • Testing the Solutions: We ensure the solution meets the listed requirements and works seamlessly in the client’s real-world environment through scripted demos and client-driven pilot tests.

5. Finalizing the Selection

The final stage involves a comprehensive vendor assessment, looking at financial stability, product roadmap, and customer references. This thorough analysis ensures the final decision is well-informed and geared towards long-term success.

Learn More

For more details about fme SelectAssist, and how it can benefit your organization download the SelectAssist for RIM datasheet, and contact us to discuss your current challenges.

Download Datasheet

Why Choose fme?

Our approach is distinguished by our emphasis on understanding the technological and human factors involved in RIM package selection. Successful implementation is not just about the software; it’s about aligning with people’s work, integrating into existing systems, and adapting to future changes. With fme, you’re not just choosing a service provider; you’re choosing a partner committed to ensuring your RIM package selection is a resounding success. Join us in navigating the complexities of RIM, and let’s ensure your regulatory information management is robust, compliant, and efficient. Contact us today to get started.

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