Solutions for the CARA Platform at Generis Generate 2024

Solutions for the CARA Platform at Generis Generate 2024

by | Mar 20, 2024 | Events, Generis

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!

Let's Connect at Generate!

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.

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Maximizing Veeva the Platform for the Whole Suite of Regulatory Use Cases

Maximizing Veeva the Platform for the Whole Suite of Regulatory Use Cases

by | Mar 11, 2024 | Life Sciences, Technology Services, Veeva

There are numerous reasons why Veeva Vault has become a popular strategic platform for regulatory information management (RIM) and more–from its easy accessibility and scalability in the cloud, to its regular updates adding new innovative functionality.

However modest or ambitious Life Sciences companies’ plans to harmonize Regulatory content and standardize and streamline processes may be–potentially spanning adjacent functions such as Quality and Clinical operations–Veeva perfectly supports all scenarios with built-in futureproofing.

Common RIM Challenges

Life sciences companies often face several challenges in Regulatory Information Management (RIM) due to the complex nature of regulatory requirements, data management, and the need for compliance across different regions. A software solution such as Veeva Vault RIM can help address these challenges by providing streamlined processes, centralized data management, and compliance support. Here are a few of the common challenges that life sciences companies expect a RIM software solution to help address:

Complex Regulatory Requirements

Navigating the complex global regulatory landscape is challenging. Companies expect RIM software to provide updates on regulatory changes, guidelines, and standards to ensure compliance. The software should enable easier adaptation to regulatory requirements across various regions and countries.

Data Integration and Accessibility

Life sciences companies often deal with vast amounts of data from diverse sources, including clinical trials, research data, and regulatory submissions. A RIM solution should offer seamless data integration across various platforms and ensure that information is easily accessible, well-organized, and securely stored. This includes managing a wide range of document types and formats.

Efficient Submission Management

Preparing and managing regulatory submissions is a time-consuming process that involves compiling, organizing, and submitting large volumes of data. A RIM solution should streamline the submission process, provide templates and guidance for different types of submissions, and ensure that all documentation meets the specific regulatory standards of each region. The software should also allow tracking of submission status and deadlines to avoid compliance issues.

Collaboration and Communication

Collaboration among various departments and stakeholders is crucial in the regulatory process. RIM software should facilitate effective communication and collaboration by providing tools for project management, document sharing, and version control. This ensures all team members work with the most up-to-date information and can easily track changes and approvals.

Compliance and Risk Management

It is paramount to ensure compliance with regulatory requirements and minimize risks associated with regulatory actions. RIM software should offer robust compliance and risk management features, such as audit trails, compliance checks, and alerts for potential issues. This helps companies proactively address compliance risks and maintain a state of continuous regulatory readiness.

By addressing these challenges, RIM software can significantly improve the efficiency and effectiveness of regulatory processes, reduce the risk of non-compliance, and ultimately accelerate the time to market for life sciences products.

Veeva in a Regulatory Context

Veeva RIM (Regulatory Information Management) is a comprehensive suite designed to help life sciences companies manage their regulatory processes more efficiently. Here’s how Veeva RIM supports addressing the challenges mentioned:

Adapting to Complex Regulatory Requirements

Veeva RIM provides a unified platform for tracking regulatory requirements across different regions and countries, ensuring that companies can easily adapt to various regulatory landscapes. It includes regulatory intelligence features that offer insights and updates on the latest regulatory guidelines, helping companies stay compliant.

Streamlining Data Integration and Accessibility

The software offers a centralized repository for all regulatory documents and data, enabling easy access and management of information. It supports integration with other systems and platforms, ensuring that data is harmonized and efficiently retrieved, enhancing data accessibility and integrity.

Enhancing Efficient Submission Management

Veeva RIM simplifies the submission process through automation and structured workflows. It provides tools for creating, compiling, and managing regulatory submissions, including templates and checklists that align with specific regulatory requirements. The system also tracks submission statuses and critical deadlines, ensuring timely and compliant submissions.

Facilitating Collaboration and Communication

The platform enhances collaboration among internal teams and external partners. It offers document sharing, version control, and project management tools that enable effective teamwork and ensures all stakeholders are aligned and informed. This collaborative environment helps streamline the regulatory process and reduce errors.

Proactive Compliance and Risk Management

Veeva RIM includes risk management and compliance monitoring features, such as audit trails and automated compliance checks. These tools help identify potential compliance issues early and enable companies to take corrective actions promptly, reducing non-compliance risk and enhancing regulatory readiness.

By providing these capabilities, Veeva RIM addresses the critical challenges faced by life sciences companies in Regulatory Information Management, helping them to navigate the complex regulatory environment more effectively and efficiently.

fme & Veeva: Securing your RIM platform’s ROI

In conclusion, Veeva Vault’s RIM solutions address life sciences companies’ multifaceted challenges in regulatory information management. By providing a unified platform that adapts to complex regulatory requirements, streamlines data integration, enhances submission management, and facilitates collaboration, Veeva Vault empowers organizations to navigate the regulatory landscape efficiently.

fme is crucial in helping clients maximize their ROI in Veeva Vault. With expertise in data migration, deduplication, and enrichment, fme ensures that life sciences companies have a harmonized platform that serves as a single source of truth for regulatory information. fme’s comprehensive business consulting and strategic technical advice, coupled with its experience in system implementation and migration in regulated industries, enable clients to optimize their RIM environment’s performance. Furthermore, fme’s ability to lay out future-stage strategies for digital process transformation extends the benefits of Veeva Vault beyond the regulatory function to adjacent departments, driving the best possible outcomes and ensuring a significant return on investment.

To discuss or analyze a current RIM project or transformation requirement, contact us. We’d love to learn your challenges and discuss a specific requirement relating to Veeva Vault-based RIM.

Contact us

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Optimize and Improve Your RIM System with HealthCheckAssist℠

Optimize and Improve Your RIM System with HealthCheckAssist℠

by | Mar 6, 2024 | Business Consulting, dqMan, Life Sciences, Veeva

Regulatory compliance is more complex and crucial than ever, and organizations are under immense pressure to manage their regulatory information efficiently. In addition, the stakes have increased as health authorities responding to public pressure have become increasingly rigorous in their evaluations, issuing more fines and penalties than ever. The health authorities are also striving to standardize data submissions in ways that organizations may not be ready to meet.

Common Regulatory Challenges

Organizations face numerous immediate challenges in managing regulatory information:

  • High volume of data and documents
  • Data fragmentation over time and platforms
  • Adherence to evolving standards
  • Inefficient processes across teams
  • Compliance risks
  • Legacy systems being consolidated into new platforms
  • Frequent RIM platform updates to stay current with complex and changing regulatory environments from multiple Health Authorities worldwide

As companies grow, merge, and acquire new data, many struggle to maintain operational efficiency and ensure compliance with mission-critical global regulatory requirements.

Modern Platforms: A Double-edged SaaS

There’s no question that today’s cloud-connected SaaS solution platforms are a fantastic leap forward in technology. Unfortunately, their undeniable benefits also come with their own challenges that IT teams need to be prepared to address.

For example, today’s leading platform in regulatory information management Veeva introduces three product releases per year where the RIM Vault is enhanced with new features. Compared to historic on-prem solutions that started to become out of date the month after purchase, this is a fantastic capability. The challenge now is that new features, bug fixes, and enhancements are automatically turned on and/or configurable and have a critical go-live date regardless of whether the organization is ready. The volume of changes can be significant, and some organizations fall behind in implementing the configurable features. In addition, many configurable features are not immediately beneficial but are utilized to build a foundation for future innovations that provide additional efficiencies.

Security can be another significant challenge. An overly complex security scheme can stunt the utilization of the solution, preventing the use of features and functionality intended to provide significant user efficiency. A properly configured and maintained RIM solution should allow all its users to easily find the information necessary to complete current Regulatory tasks. Often, during solution implementations, an organization will try to configure a security scheme that is far too granular, complex, and not conducive to efficient collaboration. The overly complex security will cause frustration and loss of user adoption of the solution. It can also cause burdensome administrative overhead and limit the available scope of change requests from the user community.

The Solution – HealthCheckAssist

Implementing your RIM solution took time and money. As an experienced regulatory information management solution provider and proven migration, technology, and services partner on the Veeva platform, fme is ready to help our clients make the most of their investments. We are proud to introduce HealthCheckAssist, a comprehensive service solution meticulously designed for users of Veeva Vault RIM.

In the often-convoluted landscape of regulatory information management, HealthCheckAssist is a surgical toolbox of optimization, offering a suite of services tailored to dissect and enhance the intricate mechanisms of Vault RIM. Through in-depth stakeholder interviews and system analysis, HealthCheckAssist delves into different departments’ unique needs and challenges to develop a complete streamlining and optimization pathway that aligns perfectly with organizational objectives.

In the dynamic environment of regulatory information management, features and functionalities evolve rapidly. A standout feature of HealthCheckAssist is its rigorous review of new feature capabilities. This ensures that your organization remains at the forefront of the latest changes, leveraging the latest updates to streamline processes and enhance efficiency.

Moreover, HealthCheckAssist strongly emphasizes manageable security, with comprehensive assessments to safeguard critical regulatory data, ensure proper accessibility, and promote effective information exchange and collaboration. Shifting the focus to a manageable and sufficiently open security model is a cornerstone of any robust regulatory information management strategy. Properly executed, this security approach eliminates over-engineered access schemas and protects your information and users in an age where data breaches can have catastrophic consequences.

Benefits of HealthCheckAssist

The benefits of HealthCheckAssist are multifaceted. Organizations can expect a significant uplift in data and document quality, driven by optimizing the features and functionalities of Vault RIM. This enhancement in data and document quality is not just about accuracy; it’s about ensuring that your regulatory information is comprehensive, up-to-date, and readily accessible, facilitating swift decision-making and compliance processes.

HealthCheckAssist also includes access to fme’s unique professional administration tool for the Veeva platform, dqMan. With dqMan, HealthCheckAssist dramatically reduces the need for manual intervention and automates and optimizes key processes to free up valuable resources. Your team can focus on strategic initiatives rather than getting bogged down in routine data and document management tasks. This shift boosts productivity and enhances job satisfaction among team members, who can engage in more meaningful and impactful work.

The strategic advantage offered by HealthCheckAssist cannot be overstated. In the competitive regulatory compliance landscape, staying ahead requires keeping pace with regulatory changes and preempting them. HealthCheckAssist empowers organizations to do just that, providing a competitive edge that can make all the difference in a competitive and highly regulated industry.

Conclusion

HealthCheckAssist by fme is not just a solution; it’s a strategic partnership in your journey through the complexities of regulatory information management. Its comprehensive suite of services focuses on optimizing Vault RIM and make it an indispensable tool for any organization looking to excel in regulatory compliance.

We invite you to contact us to learn more about HealthCheckAssist’s transformative potential for your organization. Discover how it can streamline your regulatory information management processes, enhance both data and document quality, and provide a strategic advantage in the fast-paced world of regulatory compliance.

Download the HeathCheckAssist Datasheet

Added Bonus – Veeva Vault Edition of dqMan

As an additional bonus, we will also include a single-user annual license for dqMan as part of the engagement.

dqMan is a professional administration tool designed to boost productivity and maximize your efficiency as a Veeva Vault expert. Carefully crafted on the robust dqMan platform, this tool reveals the true power of the VQL (Vault Query Language) and MDL (Metadata Definition Language). It provides users with exclusive capabilities and a broad feature set while enhancing user accessibility and streamlining operations alongside the comprehensive functionalities offered by Veeva Vault Admin. Seamlessly installable on any Windows machine, our enterprise-grade software solution boasts an intuitive user interface, delivering a great user experience.

Say goodbye to manual, time-consuming tasks and focus on what truly matters—efficiently managing your Veeva Vault applications.

Solution Spotlight: The CARA Platform from Generis

Solution Spotlight: The CARA Platform from Generis

by | Feb 23, 2024 | ECM, Generis, Partners

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.

Contact us

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.

Learn more about Generate

Related Resources

 

Highlights of Generis CARA 5.10 Release

Highlights of Generis CARA 5.10 Release

by | Dec 19, 2023 | ECM, Generis

 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.

Contact us

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Veeva 23R3 Update: Newest Features for Winter ’23

Veeva 23R3 Update: Newest Features for Winter ’23

by | Dec 1, 2023 | Veeva

The Veeva 23R3 release will be coming to a Vault near you in December 2023. Read on to learn about a few of the new features and enhancements included in Veeva’s 23R3 Platform and configured solution release. We will review some of the features that require configuration or configuration adjustments to enable and discuss the value provided with these new features to help the business users decide if it makes sense to implement the changes in their environment.

Workflow participants enforcement

Workflows now have the capability to disallow certain users from participating in a task based on their participation in a separate task or a role on the record/document that is eligible for the workflow. This new feature is configurable and supports core expectations for regulated companies.

In this example, the Quality Document Approval Workflow has been configured to prevent the document owner from completing more than one task. Where a multi-step or four-eyes approval is necessary in the business process, this configuration option will allow this to be verified systematically instead of being controlled by procedures.

Workflow control screen shot 1

The document that is being sent to workflow has multiple users who can participate in the workflow based on the sharing setting.

Workflow control screen shot 2

On sending to workflow, Dominic Reviewer is included as both a Reviewer and Approver.

Workflow control screen shot 3

After clicking Start, the following message appears:

Workflow control screen shot 4

Once the duplicate participant has been removed, the workflow can be launched successfully.

Process Navigator Enhancements

Process Owners or Admins can add images to the Overview section of the Process Navigator Detail Page. This can be especially useful to guide your users on the correct documentation to select. For example, in a quality event process, it might be important to put the process flow image in the Process Navigator Overview section where distinct documents are referenced based on the decisions within a process. Users can open Vault and view the diagram to know which SOP or Work Instruction to access when completing the steps for a material deviation versus a validation deviation.

Including an org chart diagram could also be helpful where users need to select participants for an approval task, but don’t know everyone by name. A simple chart displayed within the Process Navigator along with the referenced process document can save time and effort of your business users.

First, you will need to add the provided Visual Hierarchy Image fields to any Visual Hierarchy Object types that you have configured. (Configuration/Objects/Visual Hierarchy/Object Types/Edit Object Type Fields)

Object type with image field 1

Object type with image field 2

After the fields are enabled, update the Page Layout as desired to include bound/unbound and all or one of the Image fields available.

Page layout

Once enabled, add the desired Image fields to the Visual Hierarchy Configuration in the Fields to Display in Overview section. (Configuration/Visual Hierarchy Configurations/Fields to Display in Overview Section)

Fields to display

Finally, update the Visual Hierarchy Details record to select the desired image. (Business Admin/Visual Hierarchies)

Record with image field

End users will now see the selected image when accessing Process Navigator.

Process navigator with image field

Introduction of a new Standard Data Model for Legacy Archive Data

Veeva is introducing a standard data model to support businesses migrating from a QMS into Vault Quality.  This is an exciting option to retain access to data from previous electronic QMS systems. Instead of retaining the data in an export file or separate database, this will allow the import of these records and attachments into Vault where users will have greater access to the content and information.

In addition to allowing users to access the migrated information, the recent 23R2 update provided a new Union-All report type that allows admins to configure report types that look at both the active and legacy records, which can provide valuable insights into Quality Processes. For example, where legacy Lab Investigations are imported to Veeva Vault, a Union-All report can be configured to report on current Lab Investigations as well as legacy investigations to highlight recurring issues that should be addressed without interruption from system migrations.

Union all report with legacy objects

Conclusion

Hopefully you have found some helpful information about leveraging the Veeva 23R3 update functionalities to improve your business processes and user experience. Veeva is providing useful features in each release and fme will always be looking for ways to improve your understanding and implementation approach. This is a powerful feature of a managed platform, but it can also cause challenges if updates are being pushed live to a company that 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 Veeva platform.

Contact Us

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