Why Your Migration Needs a Reality Check First

Why Your Migration Needs a Reality Check First

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 That means paying maintenance fees, meeting outdated security policies, and keeping someone on staff just to keep the lights on in a system you were trying to leave behind.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 But legacy systems often contain outdated formats, inconsistent structures, redundant or missing data, and almost always, gaps in metadata that make downstream mapping and validation difficult.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.

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.

Solution Spotlight: The CARA Platform from Generis

Solution Spotlight: The CARA Platform from Generis

The CARA Platform from Generis is a versatile, low-code foundational content and data management platform designed to solve the complex needs of regulated industries such as pharmaceuticals, biotech, medical devices, other life sciences and other highly regulated sectors. With adaptable configuration options and Generis’ deep understanding of user workflows, its flexibility and user experience are a comprehensive solution to a wide variety of complex business challenges. Learn more about the CARA Platform below, and contact us for more details and a demonstration of what it can do for you.

The CARA Platform – Greater than the sum of its parts

An incredibly scalable platform, the CARA Platform is ready to solve a variety of business challenges. With recent updates, the CARA Platform is equally suited to storing content or storing contentless objects, providing configurable flexibility to be be used for almost any industry. On top of this is the CARA Life Sciences Platform: an interconnected suite of applications specifically for Life Sciences companies that provides a unified Regulatory, Quality, Safety, and Clinical process management. It is an easily configured and pre-validated apps platform leveraging distinct modules that simplify and streamline system administration tasks.

Powerful Architecture

The CARA Platform is back-ended by ElasticSearch, a non-relational database built on Lucene, which offers scalability and disaster recovery. ElasticSearch is specifically designed to scale to handle millions of events per second and petabytes of data.

Flexible Configuration

The CARA Platform boasts a low-code approach with an in-browser configuration interface. Generis has included a broad menu of capabilities that can be configured without any knowledge of code or query language. Where the extensive configuration options cannot meet a design requirement, scripting is available directly within the configuration interface. Implementation teams are able to script, test, and publish custom actions and other scripted activities without accessing a server or setting up an integration. The ability to embed scripting within a configuration item makes the entire application portable between dev/test/prod environments without the need to make any changes at the server level. Additionally, configuration changes are available immediately in the environment, requiring, at most, a browser page refresh. This supports a seamless user experience with substantially less downtime for updates.

Shared Administration Ownership

To maximize user adoption and useability, businesses can empower users to manage their own configuration in the CARA Platform. While core admins can manage type definitions and other configuration items with the potential for broad impact, it is possible to expose 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. Leveraging this capability can alleviate day-to-day administrative activities for core admin teams, freeing resources to work on priority projects and initiatives.

User Experience

The end user experience is often the greatest consideration when selecting a platform. The CARA Platform provides a well-planned user experience which due to the ElasticSearch backend is incredibly responsive. Users will find click/search/view actions beyond other content management solutions and will be able to quickly adopt the CARA Platform due to the potential for them to configure parts of their platform to their own requirements.

On top of the robust configuration options available within the CARA Platform, the Generis team is collaborative, responsive, and informative, constantly improving on the product to provide a satisfying end user experience.

Generis, The CARA Platform, and fme

The CARA Life Sciences Platform is an excellent option to provide the functionality needed for the client solution. Through our years of partnership, fme has successfully implemented and configured the CARA Platform for many business processes:

  • Controlled content and data management
  • An archive solution
  • Living-document management with collaboration capability
  • Validation documentation and execution solution
  • Organizational Knowledge Management
  • And many more

To learn more about how the CARA Life Sciences Platform can solve your content and data management and user workflow challenges, contact us using the form below. We’d be happy to provide more details and a demonstration of the full capability of the CARA platform, and help determine if it is the right solution for your business goals.

Generis Generate

fme has had a long partnership with Generis, working together on solutions for organizations in many industries. In April of 2024, fme will be a sponsor of Generis’ annual Generate conference being held in Lisbon, Portugal. If you are attending, please let us know! We’d love to connect with you while we are there. If not, send us your questions and interests and we’ll bring you back a summary of the topics and presentations that match your needs.

Will we see you at DIA RSIDM 2024?

Will we see you at DIA RSIDM 2024?

Will you be attending DIA RSIDM 2024 in Bethesda, MD in February? This annual event is the premier gathering for professionals working in the pharmaceutical, biotechnology, and regulatory industries, focusing on the critical aspects of submissions, information management, and document compliance.

The importance of operational efficiency across the full process and technology environment that enables the management of regulatory information cannot be understated. It is vital to provide timely, quality regulatory submissions to health authorities in order for drug companies to accelerate the delivery of therapeutics and vaccines to their patients. At DIA’s Regulatory Submissions, Information, and Document Management (RSIDM) Forum, industry and regulatory stakeholders collaborate to examine current and evolving data standards and requirements and effective regulatory information management approaches to align related people, processes, and technology.

If you’ve attended in the past, the 2024 Forum includes a refreshed set of tracks and focus areas that will provide invaluable insights on how to build and sustain successful RSIDM foundations, optimize their current processes and procedures, adopt innovative technologies, and achieve regulatory excellence. You’ll also have ample opportunities for networking, knowledge sharing, and education for both business and technology-focused topics at all levels.

Connect with fme’s David Gwyn at DIA RSIDM 2024

This year, fme’s own VP of Business Consulting David Gwyn will be attending DIA RSIDM @presenting and contributing to the many discussions with industry and regulatory stakeholders covering the effective strategies to align related people, processes, and technology for business success.

Use the contact form below to get connected before the event, or make plans to join his session on February 14:

Leveraging Structured Content Authoring in Regulatory Submissions: Real-World Experience, Industry Insights and Tools
View Session >>
Feb. 14, 8:30am
Bethesda North Marriott Hotel and Conference Center
Brookside (Lower Level)

Other Essential Sessions

If you haven’t reviewed and selected your sessions yet, here are just a few we feel are worth the time to attend. Hope to see you there, and let us know if you have any questions on these topics!

Fostering Trustworthy and Responsible AI
View Session >>
Keynote Address
New and emerging technologies like AI have undeniably proven their potential in optimizing processes, improving decision-making, and enhancing the collection and management of data across the lifecycle. Reggie Townsend, VP of Data Ethics Practice at SAS, will share insights on how AI and other emerging technologies can be responsibly leveraged in regulatory affairs and operations.

The Future of Regulatory Submissions: Innovation of the Possible using a Non-disruptive Framework
View Session >>
Technology may be disruptive and revolutionary but must be introduced in a non-disruptive way to a highly regulated environment. Innovation within the CTD / eCTD v4.0 framework including cloud computing provides exactly this vehicle for change.

Shaping and Overseeing Regulatory Strategy, Operations, and Vendor Relationships
View Session >>
Enable high-quality relationships between clients and vendors in the regulatory submissions space, and successfully shifting from a vendor-based RIM model to an in-house operation. We will also delve into acquisitions and mergers/partnerships as they relate to strategy and execution in submissions operations.

So, You Think Technology Solutions are Failing your Content Transformation? Did You Set Them up for Success?
View Session >>  
The most successful intelligent automation implementation teams think content before software: a software-agnostic mindset is key to success. This session will discuss how applying a software-agnostic methodology can supports effective content transformation across people, processes, technology, and data/content.

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

Life Science Insights: Build a Platform Roadmap

Life Science Insights: Build a Platform Roadmap

The traditional ‘best of breed’ approach to departmental systems in Life Sciences is losing popularity. That’s as a more comprehensive ‘platform’ approach enables greater flexibility, adaptability, and interoperability including data sharing. But change can feel onerous so it’s important to develop a strategy that’s both future proof and non-disruptive to your organization. fme’s professional services team can help you strike the right balance.

All organizations are striving to be more agile, productive, and cost-efficient, and none more so than those in the Life Sciences industry where the pressure to adapt and change is constant. And as long as individual business functions, such as Regulatory, Clinical, Quality, and Safety, continue to operate in silos using their own systems, data and document formats to fulfil their respective business processes, costs and complexity will increase rather than diminish.

Challenging the status quo can feel daunting, but Life Sciences organizations have limited choice about this. For many years, the ‘best of breed’ approach to deploying technology promised organizations optimal functionality as well as protection from single-vendor point of failure. But as data exchange and flow between teams and external parties (such as Regulatory agencies and outsourced partners) has grown in strategic importance, the pressing priorities now are platform and data standardization, simplification, and unification. A single, holistic platform approach is also ultimately easier and more cost-efficient to run and manage.

That’s not to say that any one software vendor has 100% of the functionality a Life Sciences company needs. The leading platform players, with a well-established end-to-end business capability, probably get close to ~90% while supporting the integration of peripheral elements such as submission publishing or specific IDMP components to provide full coverage.

This offers companies something to aim for, even if they do this incrementally via a phased approach.

Triggers for change: M&As,  persistent pain points, new regulations

The best roadmaps for digital transformation allow for steady, manageable progress toward a simpler and more flexible future, while delivering (relatively) easy wins along the way.

There are many triggers that can initiate a technology change.

  • A company merger inspires a more modern IT solution stack
  • The incoming company in an acquisition has a mature business application platform and business process
  • New industry regulations compel function-specific changes that are too onerous to apply

When these opportunities present themselves, the important thing is not to make another siloed decision, but to work toward a more modern, harmonized, and agile future state.

For instance, if Regulatory demands are becoming overwhelming, platform-based transformation could start here – applied initially to registrations (core data about licensed products), and archived submissions (aligned to that data). A next phase can then progress to content authoring, review, and approval process management.

Once Regulatory processes have been migrated to a modern cloud platform, companies can look to prepare Clinical, Quality, and Safety data and business processes for migration to the same core platform. Then each can access and add to the same core/master data set – enabling a unified platform.

One of the powerful benefits of tackling platform-based system modernization incrementally is that it presents the chance to bring people along on the journey. Teams have to opportunity to learn what works and what doesn’t, and refine features, processes, and capabilities along the way.

To ensure that any new system- and data-based decisions move the company in the right direction, and reap maximum returns, it’s important to be methodical in setting and following a strong overarching platform strategy.

We recommend:

  • Establish the right mindset and gain leadership commitment and buy-in to a long-term platform-based technology and data management strategy.
  • Start with a thorough ‘Phase 0’ assessment and gap analysis across the interlinked lines of business (Regulatory, Clinical, Quality, and Safety) to establish what’s possible and the level of work and investment that will be needed. This process could take 6+ months, depending on the size and complexity of the organization and its portfolio, and the current level of digital maturity.
  • Bring in the right talent, both externally in terms of vendor and systems integrator/IT services support, and internally so that there are subject matter experts on the client side. These SMEs are essential to work with external providers to help confirm an appropriate roadmap and determine the investment in time and skills that will be needed on both sides to ensure success.

Benefits of a platform roadmap

A strategic platform roadmap will provide substantial guidance and benefits over time. With the support of an established modern, cloud-based platform, business functions will start to behave like well-oiled machines, optimized in their process management and ability to re-use the latest data on demand. Because cloud-based platforms are updated frequently, teams will be ahead of and less reactive to changes such as Regulatory updates as these continue to occur in the interests of patient safety and enhanced patient experiences.

The same goes for scope to add new functionality and incorporate the latest technology advances. A recent example is the emerging capability of AI solutions at they become more accessible, relevant to, and proven in Life Sciences processes.

Additionally, phased approach to modernization, as part of a longer-term single-platform strategy and roadmap, means that the business will encounter minimal disruption. There is an opportunity to socialize, mature and optimize new functionality so that it works well for everyone. Crucially, no new and costly legacy dead-ends will be created.

How fme can help

fme’s team of Life Science experts can support the entire end-to-end digital transformation experience. This starts with providing deep Life Sciences industry-specific business and IT deployment experience and best practice guidance to help shape the right long-term platform strategy via our Business Consulting team. We then provide full technical implementation, integration, and comprehensive migration services supported by a rich toolkit of solutions accelerators that are exclusive to fme.

We are a client-focused provider dedicated to your success. We partner with all of the major Life Sciences platform solution providers, so we are able to provide recommendations and services that meet the unique needs of your company with the most effective solution, and work in partnership with your own IT team.

Once the new platform is live, we also provide an intense ‘Hypercare’ package combining full business, technical and administrative support, as well as appropriate change management and training. Finally, we provide exceptional post-implementation managed services with fme PlatformAssist™ to maintain your environment through application updates, process improvement and daily support.

To learn more about our full range of services, and to discuss your specific requirements, contact us today. We’d love to help you establish your long-term roadmap to technology and business success.

Highlights of Generis CARA 5.10 Release

Highlights of Generis CARA 5.10 Release

 Generis recently released a new version of CARA, their top-tier content management platform  designed for highly regulated industries, with powerful functionality for security and compliance across business-critical processes. As described in Generis’ December 5 webinar, this release incorporates a number of exciting and valuable features for users and administrators, all delivering compelling reasons to upgrade. fme’s content management experts Alicia Whitney and Jason Montgomery have been examining the details of this newest update, and have summarized many of the high-points that Generis users should look forward to.

Generis CARA 5.10 User Experience Improvements

Always striving to make the platform easier to use, this release includes several key features focused on improving the user experience.

  • My Checked-Out Documents
    The My Checked-Out Documents node has been added under My Desk in the Navigation Tree. Users will be able to access their in-progress documents with one click instead of searching for the document.

     

  • MFA codes available via email and hidden initially for security
  • New column configuration window
    CARA is a highly configurable platform that allows multiple Views to be created and configured for each type. The addition of a Column configuration window for the end user provides additional value and enables an even more flexible, tailored user experience. Users may prefer to re-order the columns that have been provided prior to exporting to Excel, or prefer to view only a limited subset of metadata available to them. In any scenario, the user can click the new icon and intuitively select and adjust the columns displayed.

  • Expand All options for Structure Manager and folder hierarchies
    When users are browsing through folders, it takes time to click through each node to expand the folder. Users will appreciate this enhancement when accessing content; a single click will display all nodes in a structure or all levels of folders.

Administrative Experience Improvements

Administrators will appreciate some new functionality that will support their activities as well as making the system more compliant.

  • Notification templates can be set individually to active/inactive
    In previous versions, notification templates could only be created, edited, or deleted. It was not possible to set a notification template to inactive temporarily or in lower environments. This option will allow admins to retain templates for reuse or copying that can provide efficiencies.
  • Workflow and Lifecycle Diagram export option
    Workflows have a diagram option in the UI that is now exportable. These diagrams can be very useful in documentation, validation testing, as well as for user training.
  • UUID
    The 5.10 version of CARA provides the option to assign a Universal Unique Identifier instead of an object-based incremental ID.
  • Custom Actions that are executed by a Privileged user cannot be edited by non-admin users
  • Limited view of the control panel and options to update only selected config elements and cannot create new configs
    This configuration option offers added flexibility in administration of the system. It is not feasible or recommended to expose the entire configuration to all administrators or skilled users. With this configuration setting, you can expose certain areas to skilled users or limited access administrators, alleviating the load of simple administrative activities like updating a dictionary or adding users into a group. Additionally, limiting the capability of editing and creating new configurations ensures control over the system behavior and provides skilled users and junior admins some confidence to make the necessary updates without worrying about breaking the system.

ElasticSearch in Generis CARA 5.10

It should be noted that for those who host their own CARA instance(s), v5.10 only supports ElasticSearch 8.9. If you are still running OpenSearch, this means a migration is needed to get to CARA 5.10/ElasticSearch 8.9. Furthermore, the current OpenSearch version will drive the method you will use to perform the migration.

There are two paths depending on your current OpenSearch version:

  1. OpenSearch 1.3 – requires the use of LogStash
  2. OpenSearch 7.10 – requires the use of Snapshots

Option 1 – OpenSearch 1.3

Fortunately, Generis has defined both migration processes in the CARA 5.10 Installation Guide, and where required, scripts to complete the process. Let us start with migration from OpenSearch 1.3.

This process requires access to a Linux server having a connection to both the source OpenSearch and target ElasticSearch. This server also requires an installation of Logstash. If you are unfamiliar with Logstash, learn more here.

“Logstash is a free and open server-side data processing pipeline that ingests data from a multitude of sources, transforms it, and then sends it to your favorite “stash”.

The first step copies the OpenSearch indices and index templates from OpenSearch to ElasticSearch. This is done using the python script provided by Generis in the CARA Installation Guide.

After the indexes have been migrated, the actual data is migrated using the Logstash utility. Again, Generis has provided a script to do this as well as instructions for ensuring that Logstash plugin is installed on the source OpenSearch instance. After updating a configuration file to direct the script to source and target, the script will connect to OpenSearch, pull down all data and then connect to ElasticSearch and import it.

Option 2 – OpenSearch 7.10

For those currently running OpenSearch 7.10 the process is slightly different. Here are the pre-requisites:

  • An existing ElasticSearch 8.9 deployment that is up and running with the “analysis-icu” extension added (see the CARA 5.10 installation guide for extension installation steps).
    NOTE: CARA only supports the Hot Data and Content tier.
  • A snapshot of the source OpenSearch data sitting in an AWS S3 bucket
  • Access_key, secret_key and session_token from S3 for ElasticSearch so that it can read the OpenSearch snapshot.

Login to elastic.co and choose the “Manage” option for the target deployment. Choose the “Snapshots” option, then “Snapshot and Restore” then “Repositories”. Here you will register the S3 bucket containing the OpenSearch snapshot as a repository using the S3 bucket connection details. Once your snapshot is visible, select it and click the “Restore” button.

When the Restore process is complete, redirect CARA from the old OpenSearch to the new ElasticSearch instance by updating the cara.yml file.

For more details, such as the exact parameters for connecting to an S3 bucket etc., please consult the CARA v5.10 Installation Guide.

fme is a Certified Generis Partner

The Generis CARA 5.10 release has multiple new features and updates that will improve your business processes and user experience. For more information about CARA and how it can solve the challenges of highly regulated content environments with powerful functionality for security and compliance across business-critical processes, please contact us. fme is a certified partner, and ready to guide you through the review, planning, migration and implementation process. 

Generis continually adds useful features in each release to keep its users supplied with the most effective tools to achieve their business goals. This is a powerful feature of a modern platform, but it can also cause challenges if updates are released and a company hasn’t had time to review and verify the changes within their own system. fme PlatformAssist™ is specifically designed to address this challenge by providing in-depth Vendor Release and Application Change Management, as well as Application and Administrative Support in a customizable set of modular building blocks that match your needs.

Contact us to learn more about fme PlatformAssist™, and find out how easy it is to have affordable, carefree release and post go-live management of your Generis CARA platform.