Maximize the ROI of Your OpenText Documentum Investments

Maximize the ROI of Your OpenText Documentum Investments

For years, OpenText’s Documentum has been gold standard for content management in the most complex industries like Life Sciences, Finance, Energy and more. Their newest solutions and AI-driven capabilities continue to push the industry forward, providing an ever-expanding catalog of tools that are proven successful in the most demanding environments. This legacy of success is a benefit to long-time OpenText customers, but it also comes with challenges.

 

Here are a few of comments we hear from our OpenText clients:

Benefits

Challenges

OpenText provides established and stable technology that reliably delivers our content management needs. Groundbreaking at the time, the most stable and effective solutions were designed for requirements and accessibility demands in a very different global technology landscape.
Our workflows and processes have been developed, tested, and proven to serve our business requirements. As technology and user expectations evolved, legacy solutions often fall behind in ease of use and user experience.
OpenText has a full suite of products to serve the varied requirements of the departments within our business. More clients are taking a best-of-breed approach, and struggle to integrate new best-in-class solutions with legacy systems.
OpenText professional services have in-depth knowledge of their solutions and provide support as we need it. Integrated systems require knowledge of all sides of a technical integration; we need experts with experience connecting solutions from multiple vendors.
Our OpenText solutions do exactly what we need them to do, and those needs have not changed. Evolving software can deprecate critical functionality, requiring complex analysis and re-work to align with upgrades. Maintenance fees for legacy solutions keeps increasing while in other places completely disappearing as older versions are being sunsetted.
OpenText continues to release new products that both compliment what we have and also bring value to new areas. New products and their associated pricing tiers can require new license structures that increase costs.
Our internal IT and Operations support team is fully versed in every aspect of our OpenText environment and can quickly address any issues. Skilled IT and Operations staff are in high demand. It can be difficult to maintain a knowledgeable team as they progress in their individual careers and expand their skills with newer solutions.
All of our data requirements – file formats, data structures, metadata structures, directory structures – have been used, verified and validated. We know where everything should be. Through mergers and acquisitions, workflow changes, new business opportunities and more, we have several repositories of data that don’t quite match existing structures. Some data is isolated in disconnected silos.
All the data, documents and metadata we have ever created in the 20 years of our firm is stored and accessible. Costs of storing and maintaining unused legacy data can quickly cost more than its inherent value, and bog down queries and processes that only need current information.
OpenText has announced many new AI features that we plan to get the most advantage from in the next few years. Initial analysis shows that our data and content isn’t in the optimal format to empower AI capabilities, and if not fixed, could expose us to substantial risks.

How fme Maximizes the ROI of OpenText Investments

fme has served OpenText clients around the globe for 25 years, and we understand the challenges of building and maintaining a complex and highly regulated content management environment. There are a wide range of considerations that must be continually balanced: license costs, maintenance requirements, support teams, integrations, functionality, evolving regulatory requirements, shifting business goals and more. We pride ourselves on delivering comprehensive solutions that accomplish our client’s unique business goals, and helping them minimize their total cost of ownership (TCO) while maximizing their return on their software investment (ROI).

With each client, we collaborate through our proven analysis and delivery methodologies to provide the most effective combination of services:

  • Streamlining and Optimization – Workflows and processes evolve over time as businesses grow and requirements change. Aligning legacy systems with current workflows can save substantial time and money.
  • Data Classification and Re-Integration – Data is stagnant, but business and processes evolve constantly, causing disconnects between what was stored then and how it’s stored now. Mergers, acquisitions and divestitures can introduce additional data with different formats. We can classify and verify all your data, update necessary fields and metadata, and re-integrate information that was lost in disconnected silos.
  • Storage and Maintenance – As solutions move to cloud services, data storage is once again becoming an expensive challenge. fme can help you analyze and evaluate your data, identify what needs to be actively available and what can be moved to lower cost options, and archive information that is rarely needed.
  • Upgrades and Application Support – Upgrades can provide new features and capabilities, but they can also break (and even reveal) existing customizations that are critical to business workflows. fme’s experts can help you determine the benefits and conflicts in an upgrade package, and determine the most effective way to upgrade with the least effort and disruption.
  • Migration to Newest Solutions – No software will last forever, and there will be times the most cost-effective approach is to move to the newest platform. Whether staying within the OpenText family or moving in a new direction entirely, fme can help determine the best path forward that aligns with your technology needs, timeline, and budget.

Work with fme to Maximize Your OpenText Landscape

Are you looking for ways to improve your ROI across the multiple departments that rely on your OpenText solutions? Talk to us. It absolutely pays to engage the right partner with experience in complex regulatory data, your source platform and any required archiving steps, workflows of data-dependent business processes, integration between platforms in a modern IT environment, and of course the current best-practices and strategies to get the most from the OpenText IT landscape.

We provide:

  • An experienced team: We have been the premier solution provider in highly regulated industries for 25 years, serving the largest pharmaceutical, manufacturing and finance firms on the globe. We understand the challenges and possibilities that drive your success.
  • ECM solution knowledge: We have been certified and recommended partners with the most effective ECM solution platforms throughout the last 25 years: Veeva, OpenText, Generis, Alfresco, SharePoint, IBM Filenet and more. We know the possibilities, best practices, and pitfalls of each one, and how to maximize your system ROI.
  • Business process experience: We’ve worked with hundreds of clients in a wide range of industries. We understand your business processes, and cross-industry best practices that will help you achieve your goals.
  • End-to-end solutions: Our team can take you from beginning to end on any project, analyzing your business processes, classifying your data and documents, planning and building your new platform, migrating and validating everything with minimal downtime.
  • An ROI and future-proof approach: You need a solution that provides both short- and long-term ROI. We deliver solutions that meet today’s needs and lay a flexible foundation so you can meet tomorrow’s expected and unexpected changes.

Download details below, and contact us to talk with our OpenText experts. We look forward to working together to maximize the ROI and minimize the TCO of your OpenText solutions.

Simplify Your Migration to Generis CARA

Simplify Your Migration to Generis CARA

Recently, we’ve been helping several leading life sciences clients understand the details, requirements and powerful possibilities of a migration to Generis CARA. If you are unfamiliar, we highly recommend taking the time to learn about the platform to compare your current challenges against CARA’s capabilities. Here’s a quick overview to get you started. Download our Generis datasheet for additional details and to request to meet with fme’s Generis CARA experts.

About Generis CARA

First off, the CARA Platform from Generis is a versatile, low-code foundational content and data management platform designed to solve the complex needs of industries such as pharmaceuticals, biotech, medical devices, and other highly regulated sectors. Regular updates and an experienced eye on the future of content management allow the CARA Platform to deliver a comprehensive, scalable solution equally suited to storing content and contentless objects, providing configurable flexibility to be used for almost any industry.

For life science firms, there is the CARA Life Sciences Platform: an interconnected suite of applications specifically designed to address the challenges of companies with interconnected Regulatory, Quality, Safety, and Clinical processes. It is an easily configured and pre-validated apps platform leveraging distinct modules that simplify and streamline system administration tasks. Generis CARA provides the connectivity, visibility, consistency and capability to reduce re-work and wasted effort and take control of business processes.

Generis CARA provides:

  • Powerful Architecture: The CARA Platform is back-ended by ElasticSearch, a non-relational database designed to flexibly handle millions of events per second and petabytes of data.
  • Flexible Configuration: The CARA Platform boasts an in-browser configuration interface with a broad menu of capabilities as well as direct scripting for advanced requirements. Implementation teams are able to script, test, and publish custom actions and other scripted activities without accessing a server or setting up an integration. This supports a seamless user experience with substantially less downtime for updates.
  • Built in AI Features: Generis built CARA with substantial AI capabilities available out-of-the-box including practical use cases deliver tangible ROI and significantly reduce the time to search for, manipulate and create content.
  • Shared Administration Ownership: To maximize user adoption and useability, core admins can manage type definitions and other configuration items with the potential for broad impact, while exposing a limited scope of configuration to allow business leads, junior admins, or expert users to make changes to dictionary drop down lists, update dashboards, reports, and workflow templates. Used effectively, this capability can alleviate day-to-day administrative activities for core admin teams, freeing resources to work on priority projects and initiatives.
  • Exceptional User Experience: The end user experience is often the greatest consideration when selecting a platform and the CARA Platform provides a well-planned, incredibly responsive user experience. Users will be able to quickly adopt the CARA Platform and configure it to their own requirements.

Challenges of Migration to Generis CARA

While the power and flexibility of the Generis CARA Platform is clear, there is an important point to remember. In fact, this isn’t just a quirk of CARA, it is the same for any solution: all capabilities and functionality heavily depend on the organization of the data, metadata and documents it contains. A great system with redundant, obsolete and / or trivial data won’t deliver the useability, compliance requirements or ROI that a business needs to achieve its goals. Unfortunately, many companies fail to effectively prepare their data for the final migration to their target platform, mostly because they are simply unaware of the state of their data.

Here are a few of the ‘short cuts’ we’ve been called to correct:

  • Assuming 1-to-1 Transfers: This is a far too common mistake. Moving data from a legacy solution to a new, modern platform will never be a 1-to-1 transfer. The way software developers store and even think about data changes continuously. New structures, formats, and metadata requirements evolve to be more efficient and compatible with new systems and coding languages. Think about it: If a data structure hasn’t changed, there’s a high probability the platform isn’t evolving to meet the needs of today’s businesses. Tread carefully when there is an assumption that your migration experience will be easy and a simple “like-for-like” – unless you’re taking a digital solution that has the exact configuration as your legacy system, this will never work. Trust us.
  • Vendor Professional Services: This sounds like a criticism but it’s simply a business reality. Vendor professional services understand their own system, but have little experience in the structures of the many different source repositories. They’ve focused their time on building a forward-looking solution to solve challenges of today and be ready for the future. They don’t have time to train on, or more importantly, have true hands on experience with, the details of every possible legacy system or the always-present customizations and workarounds made over the years. Likewise, we have seen far too often our clients being handed a mapping specification by vendors and told to fill it out. Good luck! You are going to need it without industry and migration expertise on board.
  • AI and ‘Automated’ Tools: Emerging AI-based data analysis tools promise a lot, and some are more accurate than others, but they aren’t prepared for the intricacies of regulated data, compliance regulations and requirements, or improperly stored and classified data. The consequences of failure are high, and AI-based tools without detailed human review haven’t proven they can accomplish the tasks required without adding substantial risks.
  • Relying on Internal Resources: We have worked with amazing teams, but even the most skilled internal resources rarely have the required time to focus on a full migration effort. It is also rare for them to have the depth of knowledge required within both their existing system and the newly updated CARA platform. Many times, we’ve seen deadlines extend far beyond initial plans as skilled internal resources are shifted to other priorities and data preparation receives less focus. This inevitably causes sacrifices and short cuts, increasing risks of errors and detrimental business consequences. In some cases, we are called in after the fact to support massive remediation efforts due to the rush job of simply shoving data in to meet a deadline.

fme Simplifies Migration to Generis CARA

The bottom line is, an accurate, organized data migration is essential for the success of any digital transformation initiative. This is our focus. fme has become the industry leader in successfully executing the complex migrations that allow industry leading firms take advantage of the most powerful new solutions. In fact, after over 20 years of migrating data from all leading platforms, we are experts at extracting, transforming, and importing legacy data effortlessly from any source system, including databases, file shares, cloud platforms, and legacy applications.

As a certified Generis partner, we understand the requirements, functionality and configuration options of the CARA Platform. Let us help you ensure your data is transferred accurately and efficiently, on time and on budget, so you can achieve the full value of your investment in the CARA platform. Download the datasheet below to learn more about our data migration methodology, as well at the additional ways we can support your transformation journey.

Modernization, Transformation and Data Migration with Steve Gens

Modernization, Transformation and Data Migration with Steve Gens

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 >>

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.

Deep Dive into Regulatory Solutions at DIA RSIDM 2025

Deep Dive into Regulatory Solutions at DIA RSIDM 2025

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.

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.

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!

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

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

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.

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.

Moving to RIM with Veeva Vault? Here’s how to optimize your outcomes

Moving to RIM with Veeva Vault? Here’s how to optimize your outcomes

In recent years, there have been a substantial number of Life Sciences companies refreshing their regulatory information management (RIM) capabilities, with many choosing Veeva Vault-based RIM as their platform. One of the most important reasons is health authorities’ growing emphasis on data- rather than document-oriented information exchange. This emphasis on the underlying data is a critical factor in how well new platforms deliver, once deployed. It’s also why fme’s complete range of consultancy, implementation, migration, and integration services are attracting such strong interest today.

Based on decades of experiences in the regulated processes in Life Sciences, fme has developed a methodology that minimizes common risks, accelerates effective delivery, and maximizes business user buy-in. We have a wealth of multi-platform experience we leverage to expedite projects and optimize the outcomes of Veeva-based RIM deployments. Additionally, we offer a proprietary selection of certified Veeva migration acceleration tools and services not available from any other provider.

Read more below, and download our Veeva Capabilities Datasheet for an overview of how fme can assist you on your journey.

Essential steps to optimize Veeva Vault-based RIM

Here are a few of the essential steps when migrating to a Veeva Vault-based RIM solution. There are certainly more, but these are the ones that we are most often skipped resulting in substantial problems as the initiative moves forward.

1. Develop a strategy: clarify the case for Veeva for RIM/Regulatory process management

In the past, regulatory content management was largely about document management – authoring, reviewing, approving, publishing, submitting and managing health authority submissions. Now, the emphasis is moving to the underlying data which needs to be maintained in its own right as the master source of all Regulatory-related correspondence, health authority exchanges, and ongoing intelligence.

There are critical attributes of the underlying data within a Veeva Vault-based RIM platform – indeed any RIM system. If these attributes cannot be assured and relied upon consistently, the role and value of the system will be severely compromised:

  • Quality
  • Integrity
  • Currency
  • Completeness
  • Granularity
  • Richness of data

This is why transformation and migration projects must be well mapped out and planned from the beginning of the project. It is essential to plan, manage, and verify your data so that by the time of the platform ‘go-live’, everything is trusted and proven to be robust and fit for purpose.

The first step in this essential planning starts with defining a strategy for the new platform, clearly addressing these high-level questions:

  • What are your short-term requirements? Define the functionality your data needs to support to maintain your current business processes. Also take advantage of the opportunity to improve your processes, not just replicate how your business worked years ago.
  • What is your long-term vision? Your business will evolve and grow; you predict and plan for many of these changes, but others will be unexpected reactions to evolving industry requirements. Future-proof your solution by considering how the usage and accessibility of your data can evolve with you and deliver ROI regardless your path forward.
  • How should you structure your data? This is not easy, but it is critical. How should you update and manage your existing data to serve today’s needs while also providing the flexibility to serve new regulations and business processes.

Do not skip considering the above questions, or fall for the “we don’t need to update our data” fallacy. It’s best to assume that the data you migrate to the new system will require some amount of preparatory work for it to be useable and of trusted value once live within the future state Veeva system. It’s unavoidable. Use cases are likely to range from compliance with evolving, data-based HA expectations, to improved status traceability and process efficiency internally. Data-based preparation work, meanwhile, will almost certainly involve extensive data vetting, remediation, and enrichment so that only good, valid, and relevant data is migrated across to and present in the new system.

2. Assess & prepare your data – starting ASAP

Once use cases have been defined at a high level, the data preparation work should start. This can happen in parallel, but that can cause problems. The best case is to have a complete understanding of critical data elements. This will impact many of the downstream decisions in business process requirements and system configuration. Get it done early so that any of the more detailed technical work downstream doesn’t have to be re-done due to misaligned expectations of data sources, standards, or status.

The extent of the data assessment, clean-up and preparation work will be determined by its current volume, its current data quality state, and how far short it falls from target fields/format/nomenclature and granularity. It is also essential to consider the latest Regulations and projected future business requirements, data governance, and data standards.

Based on our extensive experience, we recommend a Phase 0 head-start prior to the application configuration workstream. We recommend a phased approach to all work, particularly the all-important data preparations. As a vital initial Phase 0, we propose an extensive data quality assessment. As well as examining the state of historical data, and the impact of any previous system migrations, this should include consideration of data that is no longer active – for instance, data associated with products that have long since been discontinued or divested from the portfolio. After all, there is no point investing material amounts of time and resources in cleaning up data that will never be used again – yet so many companies end up doing this because they haven’t put in the up front groundwork.

fme has an exceptional team trained in a proven methodology to conduct this vital assessment and gap analysis. Drawing on our extensive experience in a variety of RIM migration projects – involving Veeva as well as other platforms – we can quickly identify strengths and weaknesses so that resources are well targeted. In past projects we have proven that our unique process reduces errors, team frustration and stress, and minimizes waste of time and effort by critical SME resources.

Once you have established your data quality and what needs to happen to prepare it for future use, strategies and roadmaps can be set out with more confidence in Phase 1 of the data migration workstream.

Phase 1 sets out the next steps in terms of data preparation – from specific data remediation and enrichment activities, to whether these should happen while the data is still in the source system, or in transit during the migration to the new Veeva RIM platform. We can help with all of this investigatory work, plus the data remediation and enrichment, working collaboratively with your internal subject matter experts.

3. Stage & blend data & application workstreams optimally

Based on the data analysis, initial business processes, and early configuration workshops data-centric outcomes can be aligned with the Veeva configuration and implementation workstreams. Early steps in advancing the application workstream will involve conference room pilots, using example client sample data to bring the future state to life for business users and solidify requirements. The findings of the data quality assessment are critical for this process.

Now the migration workstream can start in earnest with confidence that the team is working with the correct data. First, incremental dry run migrations in logical iterations can prove that the requirements are being met. Next, formal validation can be completed. Then the production phase, either a ‘Big Bang’, an all at once approach, or strategic phases determined earlier, can begin with confidence. Finally, the project goes through an intensive ‘hypercare’ period, with all-hands-on-deck, and platform-knowledgeable post go-live support services continually available. This final stage typically lasts about four weeks, and can be aligned with a detailed go-live change management program to ensure all users are informed and prepared to learn, troubleshoot, and adopt the new platform.

The partner you choose will make ALL the difference

It absolutely pays to engage the right partner across all of this work. It is vital to work with a team with experience in complex regulatory data, your source platform and any required archiving steps, workflows of data-dependent business processes, integration between platforms in a modern IT environment, and of course the current best-practices and strategies to get the most from the Veeva platform.

Working with fme can make a material difference to the success of a Veeva RIM implementation. We provide:

  • An experienced team: We have been the premier solution provider in the life sciences industry since the mid 90s, serving the largest pharmaceutical firms on the globe with exceptional content and regulatory information management solutions. We know this industry inside and out.
  • ECM solution knowledge: We have been certified and recommended partners with the most effective ECM solution platforms throughout the last 25 years: Veeva, OpenText, Generis, Alfresco, Trackwise, and more. We know the possibilities, best practices, and pitfalls of each one, and how to maximize your system ROI.
  • Business process experience: We’ve worked with hundreds of clients in a wide range of industries. We understand your business processes, and cross-industry best practices that will help you achieve your goals.
  • Vendor-agnostic solutions: Our diverse partnerships allow us to craft the best solution for your business requirements. We focus on your requirements, and unite your people, processes, and technology to reach your business goals.
  • End-to-end solutions: Our team can take you from beginning to end on any project, analyzing your business processes, classifying your data and documents, planning and building your new platform, migrating and validating everything with minimal downtime.
  • An ROI and future-proof approach: You need a solution that provides both short- and long-term ROI. We deliver solutions that meet today’s needs and lay a flexible foundation so you can meet tomorrow’s expected and unexpected changes.

To connect with our Veeva RIM experts, or discuss a specific requirement, contact us using the form below and we will set up a time to talk. We look forward to working together on your digital transformation journey.