Solutions for the CARA Platform at Generis Generate 2024

Solutions for the CARA Platform at Generis Generate 2024

fme is excited to be presenting our CARA Platform success stories and solutions at Generate 2024 in Lisbon, Portugal this April. As a certified Generis partner, we’ll be contributing to the discussions and sessions focused on maximizing the value of The CARA Platform and The CARA Life Sciences Platform, specifically built for Life Sciences applications.

Here are a few of the topics we’ll be sharing. Contact us below to schedule a custom presentation on how fme can serve your CARA Platform needs.

Successful Migrations to The CARA Platform

The fme team are experts at migrating data, documents and content into, out of, and within the leading content management platforms in the most complex regulated industries. We bring all our experience and know-how to The CARA Platform and have earned our Certified Partner badge year after year.

Whether you are moving to CARA for the first time, consolidating repositories, or upgrading to the newest release, fme understands the possibilities and pitfalls of the platform, and can ensure you have a smooth transition that delivers the maximum ROI while minimizing downtime. Our business consulting and technology services teams work together to provide end-to-end CARA implementation support to ensure your configuration and integration is effectively aligned with your business processes and goals.

Custom-built Tools and Solutions

fme has built a portfolio of proprietary tools and services to streamline and accelerate migration initiatives that we apply to CARA Platform initiatives. Each of these solutions has been tested, refined, and proven through years of client projects.

migration-center™: Save you 60% in costs and 80% in project duration with migration-center, our proprietary migration tool that is CARA ready, allowing you to minimize risks while migrating from any source system into CARA with ease. Learn more >>

MetadataAssist℠: Leverage the power of guided AI and NLP to identify and rescue disconnected content. MetadataAssist supplements your team’s expertise to accelerate the analysis, identification, categorization, and updating of metadata on millions of documents in a fraction of the time. We ensure all your information is fully organized and accessible. Learn more >>

HealthCheckAssist℠ for Generis: Don’t guess at how to improve – HealthCheckAssist tells you where you are and where you should go next based on your own priorities and business goals. Our experts analyze and evaluate your current system and provide a prioritized roadmap for best next steps to enhance efficiency and effectiveness. Learn more >>

PlatformAssist℠ for Generis: Reduce your platform management costs. PlatformAssist provides in-depth vendor release management, application change management, application and admin support and more for carefree, cost-effective management of your CARA platform. Learn more >>

compliance-center℠: Streamline, simplify, and accelerate your validation workflows. Built on the CARA platform and based on the CSA guidelines plus our 25 years of working with global pharmaceutical firms, compliance-center’s intuitive interface and clear instructions guides you through your validation process, providing detailed direction on when you can take advantage of CSA, when traditional CSV is required, and when a hybrid approach is possible. Learn more >>

Let’s Connect at Generate 2024!

If you are attending Generate, contact us so we can connect at the booth and join us for our VP of Business Consulting David Gwyn’s presentation on Insights and Best Practices for Maximizing the Value of The CARA Platform. We look forward to seeing you there!

Not attending? No Problem!

If you aren’t able to attend Generis Generate this year, we still have you covered! Connect with us below and we’ll send you the conference slides, and schedule a customized introduction to our CARA Platform solutions.

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.

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.

Webinar: Data, Documents and Connectivity – A Look at the Big Picture

Webinar: Data, Documents and Connectivity – A Look at the Big Picture

Digital transformation requires a shift in perspective, from a siloed approach to one where your entire organization is connected by shared data, content, and IT systems. Modernization and process optimization in one domain won’t advance wider business goals if other departments are still using outdated processes.

When looking at the bigger picture, there are two key steps to solving the problem.

Improving document management – Streamlined, efficient workflows and a powerful search functionality across all enterprise-wide content.

Data integrity – With better data governance and data reuse, you can reduce rework and improve compliance.

Learn about Generis CARA

As a leading content and information management solution, Generis CARA is a solution designed to solve these key issues within one powerful platform. Join Generis and fme Wednesday, May 24th to learn how to bridge the gaps in communication and information access between departments. Generis’ team will demonstrate CARA’s powerful ‘where used’ feature, workflows, and the benefits of managing all enterprise information on single platform.

Next, fme’s content solution expert Manuela Bernhardt will discuss the strategic ways to apply these insights through the implementation process, executing small, actionable steps that simplify the transition and minimizing company disruption. Ultimately, the Generis CARA platform will be an essential step to help you achieve higher efficiency, compliance, and security while adapting to the ever-evolving digital landscape.

Register now!

Don’t miss out on this opportunity to discover the potential of the Generis CARA platform for your organization. Register today by clicking on the link below. Attendance is free, but space is limited, so make sure to secure your spot as soon as possible.

We look forward to having you join us for this enlightening webinar and exploring the power of Generis CARA together.

Webinar Details

Data, Documents and Connectivity – A Look at the Big Picture

Date: Wednesday, May 24, 2023
Time: 10am EDT

Webinar: Leveraging the cloud for your business goals

Webinar: Leveraging the cloud for your business goals

This webinar was held on March 29, 2023.  The recording is available here

The best solutions provide organizations with:


One of the biggest benefits of cloud-based technology is scalability. Companies often deal with large amounts of current and historical data, and cloud-based systems allow them to easily scale their solutions as needed, without the need for expensive hardware investments.

Cost savings:

Cloud-based technology can reduce total cost of ownership for hardware, software, and maintenance costs over time. With cloud-based systems, companies only pay for the resources they need, and can adjust their usage to avoid unnecessary expenses.


Cloud-based technology are well-suited to complex integrations across other leading solutions, enabling powerful collaboration with partners, customers, vendors, and other stakeholders. Cloud-based systems provide a centralized platform for sharing data, documents, and other information, bringing together disparate data for more effective decision-making.


Cloud-based technology allows for controlled access to data and applications from anywhere, at any time on approved devices This can be particularly useful for companies with remote employees or partners, as it allows them to work together seamlessly, regardless of their physical location.


Cloud-based technology can provide enhanced security measures that are difficult to implement when integrating legacy systems. Cloud-based systems typically include advanced security protocols and encryption, as well as robust backup and disaster recovery options.

Despite these benefits and their potential impact on achieving business goals, many organizations are still hesitant to make the ‘Big Move’ that allows them to innovate faster, improve agility and responsiveness, and automate time-consuming tasks into efficient and effective operations.
Don’t let yourself fall behind on this critical technology advancement.

Join our Cloud Migration webinar

To get started on your cloud journey, join content experts Generis and fme for an informative webinar to discover the myriad advantages and efficiency gains to be made from migrating to the cloud, and how Generis and fme can provide support throughout the process.

Plus, you’ll hear from migration experts at fme about:
• Challenges with migrations in both complex regulated industries
• A case study of migrating on-premise systems to the cloud
• Why the fme’s migration-center is a proven solution in complex migrations
• Migration-center’s capabilities in both Life Science and non-Life Science regulated industries

This webinar is designed to dispel many of the fears and concerns of migrating complex, regulated companies to cloud solutions, and start you on the first steps of your cloud migration journey. Follow the link below to reserve your place today!