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 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.

Health wearables: Delivering value & compliance from medtech innovation

Health wearables: Delivering value & compliance from medtech innovation

From continuous diabetes monitors to wearable blood pressure gauges, smart hearing aids and Wearable Cardioverter Defibrillators (WCDs), academic spinoffs and medical technology startups are devising a whole host of intelligent aids to keep patients safe and improve their quality of life. But getting products to market and developing a robust exit plan relies on responsible teams being ahead of regulatory demands.

The market for smart medical consumer devices, already worth tens of billions of dollars annually, is growing and evolving sharply. These devices, also known as “wearable health tech” or “medtech devices”, are products designed to monitor and manage various aspects of an individual’s health and wellness. This includes fitness trackers, smartwatches with health monitoring features, connected scales, blood pressure monitors, glucose monitors, and more.

The rising popularity of such products is the result of a number of converging developments. First, people are becoming more conscious of their health and are seeking ways to monitor and manage it themselves – they see the potential to use technology to keep themselves well. Continued growth in fitness tracking and wellness monitoring has driven the demand for devices that can provide real-time data on activity levels, sleep quality, heart rate, and more.

At the same time, huge advances in smart digital capabilities (including connected sensors), and easier access to advanced data capture and AI-enabled analytics (e.g. cloud-connected devices), have finally made these devices technologically possible. Many wearable health devices are designed to sync with smartphones, so users can track their health data conveniently and receive personalized insights.

But all of this smart technology needs to be reliably enabled, and regulated to ensure patient safety.

Regulatory Requirements for Medtech Innovation Companies

Many of the latest medtech innovations are coming out of academia, young biotechs or incubation hubs. For these creative, science-led teams, it can be quite a leap to progress from having a promising idea for a new wearable device and coordinating its manufacture to bringing a compliant product to market, to preparing a viable business entity for sale.

When most of the strategic focus is on the innovation, and on the potential impact on patient outcomes and quality of life, it can be easy to overlook the systematic rigor and data housekeeping that will set the venture in good stead and smooth the new device’s path through licensing approvals and/or due diligence as part of an exit plan.

Starting off on the right foot is always advisable. It’s vital to ensure that initial “make-do” practices don’t have to be unraveled later in favor of something more robust, consistent, and compliant with the demands of regulatory bodies in current and future markets.

Put another way, it is never too early to adopt established industry best practice. This includes implementing an appropriate regulatory information management (RIM) system or platform that can keep the right records of product detail, in a format that is compatible with the requirements of health authorities.

Collecting data and structuring it correctly is a critical first step. Providing meaningful insights to users is important too, which means having access to appropriate algorithms and software that can analyze the collected data and present it in a way that is comprehensible and actionable. Other challenges for manufacturers include differentiation in a growing market that is attracting a lot of attention. The sooner developers can bring their products to market, the greater their chance of securing commercial advantage.

Addressing these market preparation challenges requires a multi-disciplinary approach. This will need to combine expertise in medical technology/electronics, the optimal user experience, regulatory affairs, appropriate software selection, and compliant data capture and management.

How fme Can Help

As a Life Sciences data and technology service specialist and business consultancy, fme is ideally positioned to help smart medical devices developers ready their propositions for market; or for sale to an investor or commercial entity.

From initial strategic consultancy, regulatory advice, and business transformation services, to help selecting the right RIM platform provider and preparing and organizing the right data, we provide the full range of guidance and implementation expertise to smooth the path to market.

We also help master the complexity between Hardware (Devices), Electrotonic (Sensors) and Software which is typical for smart devices (see Prof., Porter: How smart connected products are transforming competition) especially in the context of validation.

We can advise on and provide tailored services around:

  • Individual regulations in target markets
  • Required system capabilities
  • Data scoping, structuring, migration, and analytics
  • Standard operating procedures
  • Systems validation/quality management

Because we know the Life Sciences industry so well, and what’s needed to foster the right data delivery and data practices, we’ll help you maximize the payback on your product innovation and associated investment. fme can also support the necessary Sales Transformation, as selling Smart Medical Devices is different than selling just Smart Devices.  

Crucially, we are vendor independent which means we’ll provide technology and data recommendations that fit the exact needs of your organization.

To discuss your specific needs with our business or technical consultants, or discover more about our full range of services, contact us. We’d love to learn your challenges and provide an independent perspective designed to maximize your business success.

UDI compliance: Achieving end-to-end medical device traceability

UDI compliance: Achieving end-to-end medical device traceability

Compared to the safety measures and compliance hoops faced by pharma companies for human medicinal products and their ingredients, the collection, standardization and monitoring of medical device data has been relatively rudimentary up to now.

But that must change if medical device or combination product manufacturers and their component suppliers are to stay the right side of the authorities. Continuing to track products using spreadsheets is unsustainable, and is preventing a clear line of sight across component sourcing, and device production and distribution. This is both risky to patient safety, and inefficient operationally.

Pharma companies with a medical device portfolio may have focused so heavily on drug-related regulatory information management that they’ve neglected to apply equivalent systematic rigor to handling medical device product data. As new waves of international Unique Device Identification (UDI) mandates hit, and as the respective authorities look to extend the scope to component manufacture, it’s time to rebalance attention and budgets.

UDI: A Global Initiative

Around the world, starting with the most safety-sensitive medical devices, regulators are gradually phasing in a Unique Device Identification (UDI) system. This is designed to provide single, globally harmonized positive identification of medical devices across their distribution and use. The goal is to ensure that any piece of medical ‘equipment’ – whether an implant, wearable device, syringe, or MRI scanner – can be traced back to its source for safety and accountability reasons. Worldwide, requirements across more device Class types are becoming mandatory and manufacturers without UDI risk being refused market access, and may be subject to legal and financial penalties.

UDI Compliance: Traceability is empowering

From the side of the public, a major benefit of UDI is its ability to enable a swift response to quality issues for efficient, targeted, and timely product recalls. From the manufacturer side, systematic device identification and information tracking paves the way for improved inventory management and supply chain efficiency, helping healthcare providers and manufacturers track the movement of devices, minimize errors in distribution, and optimize inventory levels.

The great thing about UDI is that it promotes the standardization of data related to medical devices, making it easier to integrate and exchange information across different healthcare systems and databases. The US FDA categorizes these slightly differently than the EU, and several other regions or countries each have their own guidelines. (Click here for overriding international guidance.) But once manufacturers across the world are all using an agreed system for identifying devices, and indeed for recording and reporting adverse events, it will become easier for healthcare systems to communicate and share associated information across borders.

Technology & Data Decisions

Technologically, there are a number of considerations as Life Sciences companies look to bring their medical device identification and end-to-end regulatory information management (RIM) up to scratch. Generally, this starts with the selection of a suitable RIM platform or system; then it’s about creating the right data fields, and flowing in reliable and robust device information in a compliant, standardized, and readily-exchangeable format.

Strategic decisions include whether to choose a single-vendor software platform. This may make it easier to integrate with manufacturing/SAP systems to ensure data consistency and accuracy, as well as process efficiency, across and between functions as part of companies’ broader digital transformation initiatives. Another option is whether to settle on a best-of-breed RIM solution, which stays within its lane and does pure regulatory information management very well.

Work will be needed to assess where relevant data already exists in spreadsheets and other information silos, the state and format of that data and to prepare it for migration into the new target system. To complete the end-to-end system, manufacturing and shipping processes will need to be adapted to ensure that devices are identified and tracked consistently and systematically across the entire product lifecycle, from component manufacture (e.g. all the parts that go into a pacemaker) to post-market surveillance.

In some cases, manufacturers may decide to cease production of one device, replacing it with another so they can start with a clean sheet. But even then there will be base data from the older-generation device that will need to be migrated into the new system to save completely reinventing the wheel.

fme is your Best Partner for UDI Compliance Initiatives

As Life Science and content lifecycle experts, we can help with all of the above. Our business consultants and technical teams are deeply experienced in Life Sciences data-based system projects and end-to-end services; most of our core data team having been RIM system developers for many years.

Crucially, in addition to this vital industry inside knowledge, we are vendor independent. We provide holistic solutions that focus on your unique needs, ensuring you maximize the ROI of your technology budget. We can perform gap assessments, provide regulatory timeline updates, and advise on the optimal roadmap based on the size and complexity of your current medical device portfolio and the structure of your current associated data. fme’s experienced team guides you from beginning to end with comprehensive data migration planning, expedited execution with our proprietary tools and methodologies, plus validation and ongoing support.

To discuss a particular requirement with our business or technical consultants, or discover more about our full range of services, contact us. We’d love to learn your challenges and provide an independent perspective designed to maximize your business success.