Join fme at the Pharmaceutical Manufacturing World Summit

by The fme Team | Mar 24, 2026 | Business Consulting, Events, Migration Services, Technology Services

Every year, the Pharmaceutical Manufacturing World Summit in Boston brings together industry leaders, innovators, and manufacturing experts to explore the future of pharmaceutical production. As both attendees and sponsors, the fme team enjoys this unique opportunity to engage in meaningful conversations, exchange insights, and advise on the technology and data management strategies that shape Life Sciences manufacturing today. Many of the key themes that defined last year’s agenda continue to be critical topics within the industry.

Key Themes Shaping Pharmaceutical Manufacturing World Summit

Year after year, one common thread unifies the agenda: Data is the foundation of transformation for business success.

Whether enabling AI, supporting regulatory compliance, or driving operational efficiency, success depends on having trusted, structured, and accessible data across the product lifecycle. Here are some of the recent areas of focus we’ve repeatedly shared with our clients:

Data as a Strategic Asset

One of the most important points of the conference is data is no longer just operational, it’s transformational. Organizations are increasingly relying on high-quality, accessible data to drive decision-making across supply chains, manufacturing performance, and patient safety.

The ability to treat data as a strategic asset rather than a byproduct has finally been recognized as a competitive differentiator, and has been fme’s focus and mission for over 25 years. We help companies maximize the value and power of their data, ensuring it is structured, reusable, and ready to migrate into powerful solutions that unlock its full value across the enterprise.

Navigating Geopolitical Uncertainty

Global manufacturing strategies are being reshaped by shifting regulatory landscapes, trade policies, and geopolitical tensions. From increased pressure to localize production in the U.S. to evolving FDA leadership and AI regulation, companies are operating in an environment of heightened uncertainty and risk.

fme helps guide organizations through the dynamic data management challenges that can affect supply chain resilience, inspection readiness, and compliance strategies.

Infrastructure Investment and Digital Transformation

The scale of investment in modern manufacturing infrastructure is staggering. Leading pharmaceutical companies are building digitally native, highly automated facilities designed for flexibility, speed, and advanced modalities like cell and gene therapies.

Technologies such as digital twins, robotics, IIoT, and integrated MES/QMS platforms are becoming foundational. At the same time, organizations are recognizing that less than 1% of process data is often fully utilized, highlighting a major opportunity for transformation.

To ensure technology investments address both immediate and long-term needs, it is critical to work with a technology partner that understands the technical and business goals of an integrated research, development, and manufacturing pipeline.

Pricing Pressures Driving Efficiency

With rising costs across the industry, manufacturers are under pressure to do more with less. The focus has shifted toward reducing inefficiencies, eliminating rework, and accelerating system consolidation.

This is where digital enablement and automation powered by clean, high-integrity data are playing a critical role in turning compliance into a value-generating function rather than a cost center.

Innovation Accelerating at Scale

From AI-driven quality transformation to novel manufacturing platforms, innovation is rapidly reshaping the industry.

Highlights from last year included:

AI-enabled quality systems and predictive manufacturing
Expansion into advanced modalities like ADCs and cell therapies
End-to-end digital supply chain orchestration
Increasing use of GenAI to enhance quality and operational efficiency

Organizations are not just experimenting. They are scaling these innovations to drive measurable business outcomes before their competition.

Join Us at This Year’s Summit

We’re excited to return to the Pharmaceutical Manufacturing World Summit this year as a sponsor and continue the conversation with industry leaders.

If you’ll be attending, we’d love to connect! Contact us and we’ll schedule a time to discuss your current challenges, share our proven strategies and insights, or explore how to accelerate your digital and data initiatives. If you can’t attend and would like a summary of the essential topics and sessions, let us know.

Contact Us

Veeva Updates: 2025 Release Summary

by The fme Team | Feb 17, 2026 | Life Sciences, Technology Services, Veeva

Each year, Veeva updates their platform in three scheduled releases: April, July, and December. Approximately one month before each release, upcoming changes are announced to ensure administrators have adequate time to review, plan, and prepare for the coming improvements and modifications. Some changes are technical fixes with limited visible impact, while others introduce new features and functionality that clients have requested or they have developed in support of ever-evolving regulations as well as innovation. There can also be under-the-hood technical changes that require configuration adjustments or administrator preparation to allow for a seamless update.

For each release, fme’s experts receive the official announcements and distill the updates into a clear, client-focused summary. This includes outlining the changes that will impact their environments while highlighting new capabilities that could enhance their internal workflows and business processes.

Below we’ve summarized selected highlights from Veeva’s 2025 updates, and how these changes can benefit Veeva Vault users. This overview is not exhaustive. If you would like a deeper dive into the updates, or to explore how fme can help you analyze, monitor, and optimize your Veeva environment to keep it as performant as possible, download the data sheets below and contact us to discuss your current challenges.

Veeva Update 25R1 – April 2025

25R1 Key Feature

One of the more interesting elements in this release is how Veeva updated their functionality for collaborative authoring. Previously, you only could @mention users who clicked “Edit in Microsoft Office” in Vault. With this release, users are now allowed to automatically add workflow participants to the document being edited in SharePoint upon checkout in Vault, so they can be @mentioned immediately.

How this can benefit customers

Collaborative Authoring makes it much easier for teams to work on the same document at the same time without juggling emailed copies or tracking down the “latest version.” This change will speed up authoring and review cycles, reduce potential version confusion, and help teams keep content consistent when multiple stakeholders need to contribute.

Veeva Update 25R2 – July 2025

25R2 Key Feature

In this release Veeva introduced “Action Triggers”, a simple way for admins to automate actions when object records change (create/update/delete). Action Triggers reduce the need for custom SDK trigger development and can be managed through the configuration.

Action Triggers are simple “IF/THEN/ELSE” statements that can be created both before and after events for the “Create/Update/Delete” operations. They can also automatically enforce rules and populate standardized values. For example:

Auto populate fields based on metadata
Automatically set record status (Draft to In Review) when specific required fields are completed

How this can benefit customers

Action Triggers can be helpful during migrations because it can automatically handle key next steps, like updating fields, starting workflows, or creating related records as soon as the migrated data hits certain conditions. This means less manual cleanup after the load and more consistent processing, so clients can go live faster with fewer surprises later on.

Veeva Update 25R3 – December 2025

25R3 Key Feature

In this release Veeva introduced an improved multi-Vault user experience, allowing users to login and work across multiple Vaults at the same time. Prior to 25R3, the user would be logged out from one of the sessions, but now they can stay logged in when switching between the two.

How this can benefit customers

This feature is particularly useful since it allows users to be logged into both source and target vaults at the same time in one browser. This makes it much faster to compare records, confirm mappings, and validate migrated content during migrations between Vaults. It also reduces constant logouts and re-authentication, helping migrations run more efficiently with fewer user errors and quicker issue resolution.

Get the Full Release Details

For complete details on all Veeva updates, visit their site here, or contact fme below to schedule a discussion focused on your unique platform and requirements.

How fme Can Support Your Veeva Updates

Veeva’s SaaS delivery model has long provided clients with predictable, innovation-driven release cycles. However, that same continuous update cadence introduces an ongoing operational responsibility. Releases occur on a fixed schedule, regardless of internal IT bandwidth or competing priorities, and certain changes are deployed automatically. Configuration shifts, deprecated settings, and legacy customizations can all affect how new functionality performs within a given environment.

Even incremental updates can have downstream effects: missed capabilities, user friction, reporting inconsistencies, or reduced process efficiency. Sustaining ROI in a mature SaaS platform requires structured review, impact analysis, and proactive configuration management throughout the year, not just at go-live.

fme provides tailored services to help clients evaluate, manage, and operationalize Veeva’s recurring release cycles. Below are two core offerings our clients rely on to keep their Veeva environments optimized and aligned with evolving business needs.

HealthCheckAssist: Gain Visibility and Control

HealthCheckAssist is a structured, low-burden assessment designed to provide actionable insights into your Veeva RIM environment. We evaluate how the system is configured and used, identify active risks and inefficiencies, and highlight opportunities for optimization.

Beyond diagnostics, we deliver a prioritization remediation roadmap clearly outlining the steps required to stabilize, streamline, and future-proof your environment. This enables your team to proactively prepare for upcoming releases, fully leverage new platform capabilities, and maintain a consistently release-ready experience.

Learn more about HealthCheckAssist now!

Learn More

TechOps Support Services: Cost-effective Platform Management

Efficient and effective IT operations are vital for any company but are notoriously difficult to accurately predict and budget for, especially in multi-platform systems. Our TechOps Support Services provide the experience and resources needed to augment and support the needs of complex IT environments, balancing out the ebb and flow of support tasks, and adding extra knowledge and skill for integrated application management.

Our flexible, customizable model can incorporate administrative support and release management components to allow your organization to focus on your core business activities without the distractions of technical issues and system maintenance.

Our trained experts support many legacy and modern applications to ensure your critical systems remain stable and secure, giving them the attention they need while you focus on accomplishing your business goals.

Learn how fme can simplify your platform management with TechOps Support Services now!

Learn More

About the Author

Matthew Peterson

Matthew Peterson is a highly skilled Veeva business analyst and migration specialist at fme, focused on helping clients understand how each Veeva update will impact their environments. With deep expertise in the intersection of technology, data, and regulated life sciences processes, Matthew ensures that clients not only stay current with platform changes but also align those changes with their strategic goals and operational priorities. His commitment to clarity and practical impact helps organizations maintain optimized, resilient Veeva implementations that support long-term success.

A Smart Start To Digital Technology Transformations: The Power of Phase 0

by Lucas Gent | Feb 9, 2026 | Content Migration, Migration Services, Technology Services

The journey to modernize your digital technology platforms is sensitive and complex. As more companies become familiar with the intricacies and pitfalls of a digital transformation, it is becoming commonly understood that a ‘lift-and-shift’ approach to modernization is an ideal of a time gone by.

Today, companies are operating on an unprecedented scale, spanning global geographies with large expanding portfolios. The need to store, categorize and maintain healthy data has never been higher. Furthermore, this data needs to be readily accessible by related systems, workflows and people for its value to be realized and utilized.

Businesses are now looking for strategic partnerships, with a view to have a seasoned technical chaperon guide them end-to-end on their technology transformation. fme has spent over two decades helping clients navigating such waters, providing the highest standards for digital migrations.

Why You Want to Start Smart

Many companies under pressure to modernize start by looking at all the benefits the future technology can bring. This is only natural, it is one of the catalysts for change, understanding the limitations of today and looking for ways they can be relived. However, whilst looking forwards, often overlooked is the existing data and the system it lives in. Like all transformations, data readiness and compatibility is absolutely key. It will dictate the pace and complexity of the journey if not managed in a tailored and strategic manner. This leaves companies asking the question: ‘What do I actually need to do?’

Answering this call to action, fme offers initial technical and business engagement in the form of a ‘Phase 0’. This phase allows fme to leverage our in-house expertise and specialist tools to directly review your situation. With the ability to communicate the transformation requirements and complexities, we work with you to build a roadmap to suit your requirements.

The Power of Phase 0

Collaborating with fme on a Phase 0 offers a wide range of benefits for your digital transformation:

Produces an informed migration strategy that is bespoke to your digital transformation needs and requirements.
Assesses data quality and readiness, recommending actions to set your journey up for success.
Builds in your key stakeholder feedback, to develop a data specification that is compatible with the source and target system.
Shares early insights on potential challenges and how we can pre-emptively act to monitor and mitigate, reducing you overall risk.

Furthermore, we support in breaking down terminology and knowledge barriers, to support you in becoming the Champion of your own transformation journey. By demystifying the process and guiding, we look to physically and mentally set our clients up for sustainable success.

Phase 0 both de-risks the journey ahead whilst streamlining the subsequent phases to come. Whilst some unforeseeable deviations from the mapped journey may naturally occur, (e.g. Evolving client requirements) the efficiencies of operation resulting from Phase 0 allow all collaborating teams the needed time and energy to tackle such occurrences quickly and effectively.

This Is What A Smart Start Looks Like

A Phase 0 can be tailored to your schedule, typically taking a minimum of 4 weeks to complete. During this time we work with you to access your systems in compliance with your operating procedures. Whilst reviewing your source systems and data, we will host a series of workshops to discuss data quality, migration needs and how this will happen.

You will receive our findings, assessments and recommendations throughout Phase 0, all of which is documented in a comprehensive set of tangible deliverables. Typically, this includes:

Data Migration Strategy – Explains how your data migration will be performed sensitive to your requirements, complete with a verification strategy and timeline.

Preliminary Data Quality Assessment – Shares key insights on data health, migration readiness, recommended corrective actions to support the migration and broader transformation journey.

Preliminary Data Specification – Documents data stored per source and its intended target area, details classifications/notations and where they will differ between the source and target and proposes logical migratory paths.
Migration Phase 1 Scope of Work and Budget – Informed by the Phase 0 findings, outlines the activities and costs needed to successfully complete your data migration.

As your strategic partner, all findings are discussed with you directly to ensure the transfer of knowledge is maximised. We will then review this documentation, based on your feedback to further hone its accuracy; just another way we hope to further empower our clients.

Final Thoughts In A Nutshell

Phase 0 provides you with a clear project roadmap, that has an informed strategy and communicable project plan. This both de-risks the complex journey ahead whilst simplifying the subsequent phases to come. This allows our clients to make the right decisions, as they are well informed of their current situation and can lean on fme’s extensive knowledge in digital transformations, as their strategic technical partner.

More about us – It’s fme you love to work with

fme proudly focus on enabling delivery excellence for our clients, one of the many reasons why the world’s leading life sciences firms trust us with their most complex quality, regulatory, and clinical transformations. We deliver to the same high standards they follow, holding ISO/IEC 27001 QMS and ISO 9001:2015 certifications.

Your data migration deserves the best start.

Download our datasheet below to explore fme’s end-to-end platform capabilities and see how our expertise can guide your transition.

A Start Smart For Your Migration Can Start Today

Our experts are ready to help you start building your migration strategy today, to ensure data integrity, compliance, and business continuity—while setting your organization up for long-term success.

Download Datasheet

About the Author

Lucas Gent, PhD., Project Manager

Lucas Gent is one of fme’s exceptional project managers bringing a remarkable blend of scientific rigor, regulatory expertise, and project leadership to the team. He holds a Molecular Genetics PhD and is a Prince2, Scrum Master certified project manager, most recently serving within Reckitt Benckiser’s Global Professional R&D division. He is a daily user of Vault, bringing hands-on experience across technical, quality and procurement functions. He is also a seasoned Vault QualityDocs user with a clear understanding of document lifecycle management.

Webinar 🖥️ Modern Archiving for Life Sciences Enterprises: A Case Study

by Meghan Carr | Sep 11, 2025 | Generis, Life Sciences, OpenText, Technology Services

IT and Operations teams that complete digital transformation programs often face a familiar question: what happens if they decide to leave some records or documents behind? Our clients sometimes run multi-year initiatives to move onto new, best-of-breed platforms. But they may not want to bring every document or decade’s worth of data with them. Still, compliance requirements mean that historical content can’t simply be ignored. So then what? Keep the old systems running? Pay a small team to maintain them?

In today’s competitive environment, these challenges aren’t just operational, they can create a real strategic disadvantage. Let’s look at the most common pain points we hear from clients and partners.

Technical and Operational Challenges

Rising Infrastructure Costs
Maintaining outdated systems and on-premise architectures drives up costs. Hardware upkeep, security patching licensing, and support all add up, making it difficult for organizations to scale efficiently.

System Complexity and Maintenance Overhead
Years of customizations, patches, and integrations often leave legacy platforms fragile. Specialized skills are required to keep them running, but those skills are harder to find as IT professionals gravitate toward modern technologies.

Data Silos and Inconsistent Metadata
Mergers, acquisitions, and department-level repositories often leave organizations with fragmented archives. This leads to inconsistent metadata and taxonomies, reducing visibility and slowing access to critical records.

Compliance and Risk Management Challenges

Audit and Inspection Readiness
Regulators expect rapid, accurate access to historical documents. Legacy systems, with clunky user interfaces and inconsistent metadata, make it difficult to retrieve information quickly during audits or inspections.

Validation Burden
Maintaining compliance requires frequent re-validation of legacy platforms. However, even minor patches or upgrades can trigger new rounds of validation driving up costs and eating up time.

Security Vulnerabilities
Outdated platforms often lack modern safeguards such as role-based access controls, real-time monitoring, or advanced encryption. This leaves sensitive records exposed to potential breaches.

The Bottom Line

IT and Operations leaders are being pulled in all directions: rising infrastructure costs, growing compliance demands, user frustration, and leadership pushing for innovation and AI adoption.

But there is a path forward. Modern archiving strategies allow organizations to move to new platforms without dragging along every last document, while still ensuring compliance, security, and accessibility.

Case Study: fme Modernizes Archiving for Life Sciences Firm

Does this sound familiar? If so, you’re not alone, and there are clear paths forward. There are practical strategies to break free from legacy systems and move toward scalable, secure, and compliant information management.

Early in 2025, one of our global pharma clients faced this exact situation. They decided it was time to retire their costly legacy systems and replace them with a modern archiving solution that could meet today’s business and regulatory requirements.

They turned to fme Life Sciences for our decades of experience in content migrations and our deep understanding of Life Sciences business requirements. Together with our partner Generis, we combined the flexibility of the CARA Platform with the power of fme migration-center to provide a scalable, cost-efficient archiving solution that not only addressed immediate challenges but also laid a strong foundation for future AI-enabled capabilities.

View the Recording to Learn More

If you are struggling with similar challenges with the costs and barriers of legacy systems, view the recording for Modern Archiving for Life Sciences Enterprises: A Case Study to learn more about this distinctive solution. fme’s president Frank D’Entrone and Generis’ Rex Harrison will be sharing details on the project, as well as how the combination of fme and Generis solutions enabled the client to not only achieve immediate goals, but established a strong foundation for future capabilities.

Why Watch This Webinar?

In this session, you’ll learn:

- How to eliminate excessive legacy system maintenance costs and integration complexity
- Planning process and significant benefits of fme’s custom-built archiving tool leveraging Generis CARA and fme’s migration-center
- An introduction to CARA’s AI-powered capabilities for search and content interaction
- How the strategic partnership between fme and Generis benefits our clients

Webinar Details

🖥️ Title: Modern Archiving for Life Sciences Enterprises: A Case Study

📅 Date: Recorded Tuesday, October 7, 2025

Who Should Attend?

- IT Leadership (CIOs, IT Directors, Architects)
- Regulatory & Quality leaders
- Records, Information Management and Data Integrity professionals
- Digital Transformation / Business Systems Owners
- Migration & Compliance IT teams

If your teams are weighed down by the costs and risks of legacy archiving systems, this is your opportunity to learn how to modernize with confidence, especially if you have implemented or are considering modern solutions within other departments.

👉 View the recording today and be ready to learn efficient and cost-effective archiving with modern solutions.

View Recording

Why Your Migration Needs a Reality Check First

by Meghan Carr | May 13, 2025 | Content Migration, ECM, Technology Services

When you’re gearing up for a digital transformation, it’s tempting to jump straight into platform selection and implementation. You’ve picked your new system: everything else will just fall into place, right? Or better yet, let’s push the messy parts to Phase 2… or 3… or maybe 2028.

But here’s the reality check: in complex, regulated environments, transformation is never a simple “lift and shift.” Ignoring the migration side of the equation doesn’t just delay progress, it multiplies your workload. Now, instead of just launching a new system, you’re also stuck maintaining the old one. That means paying maintenance fees, meeting outdated security policies, and keeping someone on staff just to keep the lights on in a system you were trying to leave behind.

So, while you thought you were fast-tracking to the future, skipping migration planning means you’ve just signed up to deal with two systems, not one. Too. Much. Fun.

fme has spent over two decades helping clients navigating technology transformations, and if there’s one thing we’ve learned, it’s this: the biggest (and most expensive) migration problems usually existed long before the implementation even kicked off. Everyone’s so focused on where they’re headed, they forget to look back and check if there’s anything in their rearview mirror… like a major data issue.

And it’s not just the data itself; it’s the system it lives in. We take a hard look at the source system’s technical stack: how it was built, how accessible it is, what’s custom, what’s obsolete, and how long it’s realistically going to take to get clean, validated data out of it. Because that “one-click export” you were promised? It rarely works like that or it’s easy, but only your current vendor can do it at a hefty cost.

Hidden Issues Don’t Stay Hidden for Long

By the time a go-live date is on the calendar, you want everything working together: the system, the workflows, the people, and, critically, the data. But legacy systems often contain outdated formats, inconsistent structures, redundant or missing data, and almost always, gaps in metadata that make downstream mapping and validation difficult.

And if you’re assuming your new system vendor will take care of data preparation? Think again. Most vendors expect the client to come to the table with clean, validated data and a migration strategy in hand. If that doesn’t happen, project teams end up scrambling under pressure, reworking tasks, and putting compliance at risk.

Enter fme’s Migration Readiness Evaluation

The Migration Readiness Evaluation (MRE) is designed to solve these problems before they start. Whether you’re preparing for a major platform migration or just beginning to think about what comes next, the MRE helps you get a clear picture of your data and system readiness—without overburdening your internal team.

You’ll get:

A comprehensive inventory of your content and data systems
A Readiness Report that outlines the true state of your legacy content
Risk mitigation recommendations to guide decisions and avoid project derailers
A Migration Strategy aligned with your business and regulatory priorities

The process is designed to be lightweight (typically 3–6 weeks), with minimal disruption to your day-to-day work. And whether you’re evaluating one new platform or ten, the output is actionable for what you need to consider before you’ve decided, and aligned with your broader business goals.

See, and solve, the problem – before having to work the problem.

Clients come to us with different priorities, but the challenges we uncover tend to follow familiar patterns. Legacy systems are often the first hurdle with proprietary structures, siloed applications, and unclear metadata make it incredibly difficult to plan a clean, compliant migration. Then there’s the data itself: redundant, outdated, and often missing the context needed to make informed decisions. It’s no surprise that teams hit a wall halfway through their projects because that’s usually when the real data issues surface. By that point, everyone’s already eyeball-deep in a thousand other decisions around configuration, integration, validation… so dealing with legacy data suddenly becomes tomorrow’s problem. Except the go-live date? That’s set in stone. Which means you’re on track to launch a brand-new system that’s packed with the same old messy data.

That’s where timing becomes everything. By the time migration finally gets prioritized, internal teams are maxed out and there’s no bandwidth left to stop, assess, or course-correct. That’s why we can step in way ahead of time. fme takes the lead on the heavy lifting: evaluating your systems, surfacing the risks no one’s talking about yet, and making sure everyone understands what’s really in scope, before it becomes a fire drill.

And it’s not just about what needs to be moved. It’s about making sure everyone involved from the business, to IT, to leadership is working from the same playbook from the very beginning. That’s what the Migration Readiness Evaluation delivers: clarity, alignment, and a real plan built on your actual landscape, not assumptions.

Start Smart. Finish Strong.

If you’re heading into a migration or large-scale system upgrade, don’t wait for surprises to appear mid-project. The Migration Readiness Evaluation gives you the insight to plan with confidence, stay aligned with regulatory expectations, and protect your budget and timeline.

Download the datasheet below to learn the details and benefits of fme’s Migration Readiness Evaluation, and to discuss your upcoming migration initiative.

Download the Migration Readiness Evaluation Datasheet

Unlock the Power of Generis CARA for Quality — With fme as Your Proven Migration Partner

by Meghan Carr | Apr 16, 2025 | Generis, Quality, Technology Services

The life sciences industry is redefining what quality means in the digital era. No longer confined to siloed workflows or paper-era processes, modern quality management demands real-time insights, cross-functional alignment, and seamless integration across systems.

That’s why more organizations are choosing Generis CARA, a next-generation platform built not only to modernize quality operations, but to align them with broader regulatory, clinical, and enterprise goals. But reaching that vision takes more than selecting the right platform: it requires executing a migration strategy that ensures business continuity, compliance, and long-term value from effective data usability.

This is where fme delivers.

Why Generis CARA is Gaining Momentum

Generis CARA is rapidly becoming the platform of choice for forward-looking life sciences organizations that need more than just incremental improvements to their quality systems. What makes CARA stand out is its metadata-driven architecture, which enables intelligent workflows, dynamic configurations, and true cross-functional collaboration.

CARA brings quality, regulatory, safety, and clinical processes together in a truly single, harmonized environment, eliminating the inefficiencies of disconnected systems that require manual connectivity and redundant data. The platform’s modern UX, personalized dashboards, and responsive design enhance adoption and usability, while deployment flexibility (including public cloud, private cloud, or on-premise) supports a wide range of IT and compliance strategies.

With built-in interoperability and open APIs, CARA integrates naturally with ERP, LIMS, PLM, and other enterprise systems, helping quality become a connected, agile function across the business. Those who know me, know this is a major sticking point for me – stop duplicating your master data in your QMS when you can integrate with your ERP, please!

Proven Experience with Generis CARA Migrations

fme doesn’t just understand quality systems: we understand how to move them. We are actively supporting some of the world’s most complex and highly regulated organizations as they migrate to Generis CARA today. That firsthand experience gives us a deep understanding of the platform’s architecture, its data model, and the transformation steps required to get from legacy to next-gen, all without compromising compliance.

We combine that expertise with migration-center®, our purpose-built migration platform that enables large-scale data and document migrations with precision and traceability. From structured metadata to unstructured legacy documents, we help organizations classify, map, transform, and verify every record so what arrives in CARA is not only compliant, but clean, usable, and aligned with your business goals.

Our work isn’t theoretical. It’s happening now and delivering measurable value to companies modernizing their global landscapes with CARA.

What fme Brings to the Table

Making the move to a new QMS platform is a high-stakes endeavor. fme brings the tools, expertise, and industry knowledge to ensure that the migration isn’t just successful, it’s designed in line with your organization’s strategic goals. That means not only preserving compliance and continuity, but also structuring your data to support future innovation.

Whether you’re building a foundation for AI-driven quality insights, enabling advanced trend analysis, or preparing for greater integration across enterprise systems, we ensure your migration delivers usable, intelligent, and value-rich data that is ready to power what’s next. Here’s what you can count on fme for:

End-to-end CARA migration services, from legacy system analysis with our Migration Readiness Evaluation and Data Quality Assessment offerings to migration execution to legacy system decommissioning and archiving
Accelerated execution through reusable templates, automation frameworks, and proven methodologies from hands-on migrations into CARA
Change-aware transformation, built to preserve compliance history and improve future usability

We don’t just move data, we move the right data, in the right format, with the right controls to support your next-generation quality operations.

The Right Platform. The Right Partner.

Generis CARA is changing the way quality systems work. fme ensures you get there the right way: confidently, compliantly, and with a migration strategy designed to deliver value from day one.

Let’s talk about your path to Generis CARA. Download the datasheet below to learn more about fme’s capability with the Generis CARA platform, and request a personalized discovery discussion.

Download fme's Generis Capabilities Datasheet

Join fme at the Pharmaceutical Manufacturing World Summit

Key Themes Shaping Pharmaceutical Manufacturing World Summit

Data as a Strategic Asset

Navigating Geopolitical Uncertainty

Infrastructure Investment and Digital Transformation

Pricing Pressures Driving Efficiency

Innovation Accelerating at Scale

Join Us at This Year’s Summit

Veeva Updates: 2025 Release Summary

Veeva Update 25R1 – April 2025

25R1 Key Feature

Veeva Update 25R2 – July 2025

25R2 Key Feature

Veeva Update 25R3 – December 2025

25R3 Key Feature

Get the Full Release Details

How fme Can Support Your Veeva Updates

HealthCheckAssist: Gain Visibility and Control

TechOps Support Services: Cost-effective Platform Management

About the Author

Matthew Peterson

Related Posts

A Smart Start To Digital Technology Transformations: The Power of Phase 0

Why You Want to Start Smart

The Power of Phase 0

This Is What A Smart Start Looks Like

Final Thoughts In A Nutshell

More about us – It’s fme you love to work with

About the Author

Lucas Gent, PhD., Project Manager

Know what your migration requires BEFORE you start.

Webinar 🖥️ Modern Archiving for Life Sciences Enterprises: A Case Study

Technical and Operational Challenges

Compliance and Risk Management Challenges

The Bottom Line

Case Study: fme Modernizes Archiving for Life Sciences Firm

View the Recording to Learn More

Why Watch This Webinar?

Webinar Details

Who Should Attend?

Why Your Migration Needs a Reality Check First

Hidden Issues Don’t Stay Hidden for Long

Enter fme’s Migration Readiness Evaluation

Start Smart. Finish Strong.

Know what your migration requires BEFORE you start.

Unlock the Power of Generis CARA for Quality — With fme as Your Proven Migration Partner

Why Generis CARA is Gaining Momentum

Proven Experience with Generis CARA Migrations

What fme Brings to the Table

The Right Platform. The Right Partner.

Unlock the power of Generis CARA for Quality

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