Veeva 23R3 Update: Newest Features for Winter ’23

Veeva 23R3 Update: Newest Features for Winter ’23

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.

Moving to RIM with Veeva Vault? Here’s how to optimize your outcomes

Moving to RIM with Veeva Vault? Here’s how to optimize your outcomes

In recent years, there have been a substantial number of Life Sciences companies refreshing their regulatory information management (RIM) capabilities, with many choosing Veeva Vault-based RIM as their platform. One of the most important reasons is health authorities’ growing emphasis on data- rather than document-oriented information exchange. This emphasis on the underlying data is a critical factor in how well new platforms deliver, once deployed. It’s also why fme’s complete range of consultancy, implementation, migration, and integration services are attracting such strong interest today.

Based on decades of experiences in the regulated processes in Life Sciences, fme has developed a methodology that minimizes common risks, accelerates effective delivery, and maximizes business user buy-in. We have a wealth of multi-platform experience we leverage to expedite projects and optimize the outcomes of Veeva-based RIM deployments. Additionally, we offer a proprietary selection of certified Veeva migration acceleration tools and services not available from any other provider.

Essential steps to optimize Veeva Vault-based RIM

Here are a few of the essential steps when migrating to a Veeva Vault-based RIM solution. There are certainly more, but these are the ones that we are most often skipped resulting in substantial problems as the initiative moves forward.

1. Develop a strategy: clarify the case for Veeva for RIM/Regulatory process management

In the past, regulatory content management was largely about document management – authoring, reviewing, approving, publishing, submitting and managing health authority submissions. Now, the emphasis is moving to the underlying data which needs to be maintained in its own right as the master source of all Regulatory-related correspondence, health authority exchanges, and ongoing intelligence.

There are critical attributes of the underlying data within a Veeva Vault-based RIM platform – indeed any RIM system. If these attributes cannot be assured and relied upon consistently, the role and value of the system will be severely compromised:

  • Quality
  • Integrity
  • Currency
  • Completeness
  • Granularity
  • Richness of data

This is why transformation and migration projects must be well mapped out and planned from the beginning of the project. It is essential to plan, manage, and verify your data so that by the time of the platform ‘go-live’, everything is trusted and proven to be robust and fit for purpose.

The first step in this essential planning starts with defining a strategy for the new platform, clearly addressing these high-level questions:

  • What are your short-term requirements? Define the functionality your data needs to support to maintain your current business processes. Also take advantage of the opportunity to improve your processes, not just replicate how your business worked years ago.
  • What is your long-term vision? Your business will evolve and grow; you predict and plan for many of these changes, but others will be unexpected reactions to evolving industry requirements. Future-proof your solution by considering how the usage and accessibility of your data can evolve with you and deliver ROI regardless your path forward.
  • How should you structure your data? This is not easy, but it is critical. How should you update and manage your existing data to serve today’s needs while also providing the flexibility to serve new regulations and business processes.

Do not skip considering the above questions, or fall for the “we don’t need to update our data” fallacy. It’s best to assume that the data you migrate to the new system will require some amount of preparatory work for it to be useable and of trusted value once live within the future state Veeva system. It’s unavoidable. Use cases are likely to range from compliance with evolving, data-based HA expectations, to improved status traceability and process efficiency internally. Data-based preparation work, meanwhile, will almost certainly involve extensive data vetting, remediation, and enrichment so that only good, valid, and relevant data is migrated across to and present in the new system.

2. Assess & prepare your data – starting ASAP

Once use cases have been defined at a high level, the data preparation work should start. This can happen in parallel, but that can cause problems. The best case is to have a complete understanding of critical data elements. This will impact many of the downstream decisions in business process requirements and system configuration. Get it done early so that any of the more detailed technical work downstream doesn’t have to be re-done due to misaligned expectations of data sources, standards, or status.

The extent of the data assessment, clean-up and preparation work will be determined by its current volume, its current data quality state, and how far short it falls from target fields/format/nomenclature and granularity. It is also essential to consider the latest Regulations and projected future business requirements, data governance, and data standards.

Based on our extensive experience, we recommend a Phase 0 head-start prior to the application configuration workstream. We recommend a phased approach to all work, particularly the all-important data preparations. As a vital initial Phase 0, we propose an extensive data quality assessment. As well as examining the state of historical data, and the impact of any previous system migrations, this should include consideration of data that is no longer active – for instance, data associated with products that have long since been discontinued or divested from the portfolio. After all, there is no point investing material amounts of time and resources in cleaning up data that will never be used again – yet so many companies end up doing this because they haven’t put in the up front groundwork.

fme has an exceptional team trained in a proven methodology to conduct this vital assessment and gap analysis. Drawing on our extensive experience in a variety of RIM migration projects – involving Veeva as well as other platforms – we can quickly identify strengths and weaknesses so that resources are well targeted. In past projects we have proven that our unique process reduces errors, team frustration and stress, and minimizes waste of time and effort by critical SME resources.

Once you have established your data quality and what needs to happen to prepare it for future use, strategies and roadmaps can be set out with more confidence in Phase 1 of the data migration workstream.

Phase 1 sets out the next steps in terms of data preparation – from specific data remediation and enrichment activities, to whether these should happen while the data is still in the source system, or in transit during the migration to the new Veeva RIM platform. We can help with all of this investigatory work, plus the data remediation and enrichment, working collaboratively with your internal subject matter experts.

3. Stage & blend data & application workstreams optimally

Based on the data analysis, initial business processes, and early configuration workshops data-centric outcomes can be aligned with the Veeva configuration and implementation workstreams. Early steps in advancing the application workstream will involve conference room pilots, using example client sample data to bring the future state to life for business users and solidify requirements. The findings of the data quality assessment are critical for this process.

Now the migration workstream can start in earnest with confidence that the team is working with the correct data. First, incremental dry run migrations in logical iterations can prove that the requirements are being met. Next, formal validation can be completed. Then the production phase, either a ‘Big Bang’, an all at once approach, or strategic phases determined earlier, can begin with confidence. Finally, the project goes through an intensive ‘hypercare’ period, with all-hands-on-deck, and platform-knowledgeable post go-live support services continually available. This final stage typically lasts about four weeks, and can be aligned with a detailed go-live change management program to ensure all users are informed and prepared to learn, troubleshoot, and adopt the new platform.

The partner you choose will make ALL the difference

It absolutely pays to engage the right partner across all of this work. It is vital to work with a team with experience in complex regulatory data, your source platform and any required archiving steps, workflows of data-dependent business processes, integration between platforms in a modern IT environment, and of course the current best-practices and strategies to get the most from the Veeva platform.

Working with fme can make a material difference to the success of a Veeva RIM implementation. We provide:

  • An experienced team: We have been the premier solution provider in the life sciences industry since the mid 90s, serving the largest pharmaceutical firms on the globe with exceptional content and regulatory information management solutions. We know this industry inside and out.
  • ECM solution knowledge: We have been certified and recommended partners with the most effective ECM solution platforms throughout the last 25 years: Veeva, OpenText, Generis, Alfresco, Trackwise, and more. We know the possibilities, best practices, and pitfalls of each one, and how to maximize your system ROI.
  • Business process experience: We’ve worked with hundreds of clients in a wide range of industries. We understand your business processes, and cross-industry best practices that will help you achieve your goals.
  • Vendor-agnostic solutions: Our diverse partnerships allow us to craft the best solution for your business requirements. We focus on your requirements, and unite your people, processes, and technology to reach your business goals.
  • End-to-end solutions: Our team can take you from beginning to end on any project, analyzing your business processes, classifying your data and documents, planning and building your new platform, migrating and validating everything with minimal downtime.
  • An ROI and future-proof approach: You need a solution that provides both short- and long-term ROI. We deliver solutions that meet today’s needs and lay a flexible foundation so you can meet tomorrow’s expected and unexpected changes.

To connect with our Veeva RIM experts, or discuss a specific requirement, contact us using the form below and we will set up a time to talk. We look forward to working together on your digital transformation journey.

Veeva 23R2 Update: New and improved for Summer ‘23

Veeva 23R2 Update: New and improved for Summer ‘23

The Veeva 23R2 update was released to the public starting on August 4, 2023. Read on for an overview of features and enhancements that require configuration or may impact your validation activities if configured.

Veeva 23R2 update features

Override Checkout Option for State Change Document Operation Jobs

veeva 23r2 document version imageScheduled Jobs can promote or demote documents based on configured criteria. In some situations, the scheduled job action on a document fails because the document is checked out. With this release, an Admin can configure the job to expire/obsolete a document that is in the Steady State despite having a minor version of the document checked out by ticking a checkbox within the job configuration page. 

Object Lifecycle Entry Criteria: State & State Type of Related Records can be Validated with Conditions

State transitions can now be prevented using Entry Criteria to check against multiple lifecycle states of related records. Previously, only one lifecycle state could be checked for related records. An example where this configuration change would be helpful is where there is a state change that is only allowed when related child records are completed. In some cases, one or more of the related child records may have been created in error. These records would progress to a Cancelled state. If the Entry Criteria for the parent record is checking only for related child records in a Complete state, a related child record in a Cancelled state would prevent the parent record’s state change. This update in the Veeva 23R2 update will allow you to avoid this scenario as you can check for related child records in both Implementation Completed or Cancelled states.

veeva 23r2 child records image

New Report Type – Union-All

This feature adds a new report type to Vault: Union-All. This report type allows customers to combine objects in a single report. Reporting on multiple types of records at the same time can be challenging. Combining data from different object types can help with decision-making and defining process issues.

veeva 23r2 union all report image

Veeva QMS

External Collaboration: External Review & Approval of Documents

New functionality added in this release will allow you to collaborate with external parties directly from Vault-there is no need to use email or other sharing methods outside of your Vault. This can be exciting for reviewing and approving supplier agreements, quality agreements, as well as sharing reports and outcomes with contract organizations all within a compliant, validated environment.

While this is a powerful tool, there are some configuration considerations, including whether to add this step into existing workflows or to configure a separate workflow for this external review. There are a few limitations to be aware of, including the recommendation to use this approach only with a single document workflow to ensure that the background user activation works as designed as well as licensing availability. Note that the system will enable the new external user only if there is an external license available.

Create Change Actions from Template Records

Depending on your processes, you may find users are copying the content from existing Change Actions to populate new Change Actions required for similar changes. This is a laborious and potentially error-prone activity. In 23R2, you will be able to configure the system to allow users to add Change Actions using an approved Change Action Template. This controlled process will enable your users to increase efficiency and accuracy as you can build in rules that determine which fields are copied and which are editable vs. read-only. Additionally, Admins can configure the automated addition of change actions from template depending on the record entering a specific state.

Conclusion

As with each release, Veeva’s 23R2 update incorporates multiple user requests and improvements making the platform more effective over time. 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.

Join fme in Boston at the Veeva Summit: R&D and Quality

Join fme in Boston at the Veeva Summit: R&D and Quality

fme has been selected as a Gold Sponsor for the Veeva Summit: R&D and Quality for Boston this September, and we are looking forward to sharing our experience and strategies with the Veeva community. We enjoyed June’s European summit in Madrid, and are honored to be recognized in an elite group of certified partners invited to participate in the North American event.

We’d love for you to join us to explore how to leverage the power of the Veeva platform to achieve your business goals.

Join fme at the Veeva Summit!

fme specializes in the end-to-end implementation, integration, and support of the Veeva platform. At the summit our team of experts will be answering questions, discussing our capabilities, and proving how our partnership can guide organizations to new heights of efficiency and productivity. We will also be highlighting our newest offerings that deliver exceptional benefit to our Veeva clients:

  • fme PlatformAssist™ – A comprehensive set of modular building blocks that provide you with the unique end-to-end services needed for carefree post go-live management of your Veeva platform.
  • dqMan for Veeva Vault – Modeled after our popular dqMan for Documentum, our new version is focused on the specific requirements of Veeva clients, eliminating time-consuming and repetitive tasks and making admin and data management easy.
    If you are attending the summit, contact us and let’s set up a time to meet so you can get the most value from the summit.

If you are attending the summit, contact us and let’s set up a time to meet so you can get the most value while we’re there together.

Contact us to learn more

fme delivers the end-to-end knowledge and support you need to maximize the value of the Veeva platform. We’d love the opportunity to share our experience on how to best configure, utilize, and support Veeva for the unique challenges of your organization.

Contact us to schedule a personalized presentation aligned with your unique challenges. To schedule a discovery meeting with fme’s Veeva experts, reach out to our Global Sales Director René Rosenberg at r.rosenberg@fme-us.com.

Advanced administration tools for Veeva Vault applications

Advanced administration tools for Veeva Vault applications

fme is pleased to announce the development of a dqMan edition for the administration of Veeva Vault applications. Veeva Vault administrators, developers, and supporters can find updates on the development progress and release plans on the dqMan site and on dqMan’s Twitter and LinkedIn social media channels.

Extending the range of dqMan for Documentum to Veeva Vault

Administration of multifaceted content management solutions is rarely simple. fme recognized this common problem, and set out to build a solution based on our years of working with OpenText Documentum users. After extensive testing, revision, and validation, in August 2022, we publicly released dqMan, a unique, enterprise-grade solution for OpenText Documentum users to administer, maintain, and program the Documentum Content Server.

This year, we’ve expanded the capability of dqMan, connecting it with another premier solution, Veeva Vault. fme has been a services, development, and migration partner with Veeva for many years, so we were able to add our in-depth understanding of the Veeva Vault platform to extend dqMan with another powerful platform and scripting language. dqMan’s Veeva Vault Edition uses:

  • Veeva Vault Query Language (VQL) to access, retrieve, and interact with Vault data
  • Metadata Definition Language (MDL) to create, describe, update, and drop Vault components that form its configuration

The development of the additional dqMan version, designed to provide customers with an efficient administration solution for their Vault applications, is in full swing. Users can expect the full release at the end of Q2 this year.

What’s in the Veeva Vault Edition of dqMan

Among others, users can expect the following features:

  • Easy navigation through document types and objects
  • A simplified way to generate and execute queries
  • View, edit, and export query results
  • Cache query results for generating aggregated reports
  • Display metadata of documents and objects
  • View and export content, renditions, and attachments of documents
  • Compare metadata of objects
  • User-friendly way to create, handle, and execute MDL commands or scripts

Learn more about the upcoming Veeva Vault Edition

dqMan’s OpenText Documentum Edition was very well received by the OpenText Documentum use community, and we expect to see a similar response from Veeva Vault users with the release of dqMan’s Veeva Vault Edition. As experts with each of these platforms, we understand the challenges of the time-consuming and repetitive tasks required by routine work. We are excited to provide a solution that will help users become more efficient and productive, and look forward to any feedback and comments Veeva Vault users can provide.

Join fme at the Veeva Summit: R&D and Quality in Madrid

Join fme at the Veeva Summit: R&D and Quality in Madrid

Veeva Technology Certified Silver Partner
Veeva Services Alliance Partner Certification Badges with Year 2023_Services
Veeva Services Partner Migration-Certified

The 2023 Veeva Summit: R&D and Quality for clients and partners is fast approaching, and fme has been selected to share our experience and strategies as a Gold sponsor. Only a select group of certified partners are invited to participate, and fme is honored to be recognized as part of this elite group. We cordially invite you to join us to explore how we can work together to leverage the power of the Veeva platform to achieve your business goals.

Proven Success Strategies

The Veeva Conference is a fantastic opportunity to learn about the most effective trends and best practices for content management, network with industry professionals, and engage in insightful discussions. Since fme specializes in the implementation, integration, and support of Veeva content management solutions, we’ll be sharing our experience on how to best configure, utilize, and support Veeva for the unique challenges of your organization.

The Veeva Summit provides unique value to attendees:

  • Gain insights into the latest features and enhancements of Veeva’s content management solutions, how they can help you achieve your IT and business goals.
  • Understand how fme provides tailored IT consulting services to optimize your Veeva solutions, ensuring seamless operation and maximum ROI.
  • Network with other professionals to exchange ideas and learn from their experiences, helping you stay ahead of industry trends and competition.

Join fme at the Veeva Summit or Contact Us Today!

If you attend or not, take full advantage of the Veeva Conference for valuable learning opportunity it provides. Our team of experts will be answering questions, demonstrating our capabilities, and proving how our partnership can bring your organization to new heights. We will also be introducing new offerings that will bring exceptional benefit to our Veeva clients:

  • fme PlatformAssist™ – A comprehensive set of modular building blocks that provide you with the unique end-to-end services needed for carefree post go-live management of your Veeva platform.
  • dqMan – Modeled after our popular dqMan for Documentum, our newest version is focused on the specific requirements of Veeva clients, eliminating time-consuming and repetitive tasks and making admin and data management easy.
  • fme MetatdataAssist™ – Reconnect lost documents without the frustration, time, or costs to your key business resources. Let fme’s life science experts quickly and efficiently update your legacy document’s metadata to ensure they are properly classified and discoverable in your Veeva system.

If you aren’t attending, contact us to schedule a personalized presentation on how fme can provide the end-to-end knowledge and support you need to maximize the value of your information with the Veeva platform.

To learn what fme can do as your end-to-end Veeva partner and to get more details on the conference, view our Veeva Summit summary here. To schedule a discovery meeting with fme’s Veeva experts, use the form on the page above, or reach out to me or our Global Sales Director René Rosenberg at r.rosenberg@fme-us.com.