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

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

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The 2024 Veeva Summit: R&D and Quality for clients and partners is around the corner, and fme has once again selected as a Gold sponsor. Only a select group of certified partners are invited to participate, and we are honored to be able to share our experience and strategies with the Veeva community. 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.

Veeva Summit for European Clients

The Veeva Summit in Madrid is the continent’s best opportunity to learn the crucial R&D and Quality best practices and solutions for content management, as well as network with industry professionals from leading Life Sciences firms. Since fme specializes in providing Life Sciences firms with implementation, integration, and support of Veeva content management solutions, we’ll be sharing our experience on how to best configure, utilize, and support this powerful platform throughout an organization that is ready to leverage the power of advanced technology.

This year’s Veeva Summit promises to deliver unique value to attendees:

  1. Gain insights into the latest features and enhancements within Veeva’s powerful platform, and how they help you reach your IT and business goals.
  2. Understand how fme provides end-to-end solutions to optimize your Veeva environment, ensuring seamless integration, operation, and maximum ROI.
  3. Exchange ideas, network, and learn from industry professionals to help you stay ahead of industry trends and competition.

fme at the Veeva Summit

The Veeva Summit is a valuable learning opportunity. fme’s Life Sciences experts will be answering questions, demonstrating our capabilities, and proving how our experience and innovation can bring your organization to new heights. Here are a few solutions designed to deliver exceptional benefit to our Veeva clients:

  • Migration Planning and Execution – Good content in, good content out – get it right from the beginning. fme’s technical experience, business process knowledge, and proprietary tool migration-center make us an unsurpassed choice to migrate your content into the Veeva platform, consolidate legacy platforms, or migrate data Vault to Vault. Learn more >>
  • fme migration-center – fme’s proprietary migration-center solution can save you 60% in costs and 80% in project duration compared to developing your own scripts and frameworks. Learn more in our migration-center for Veeva datasheet >>
  • fme dqMan Veeva Vault Edition – Based on VQL and MDL, dqMan provides exclusive capabilities and a broad feature set designed to boost productivity and maximize efficiency by eliminating manual, time-consuming tasks. Learn more >>
  • fme HealthCheckAssist – Personalized roadmap to Veeva success. HealthCheckAssist provides an in-depth assessment of your current configurations and usage of your Vault RIM solution, then delivers a detailed report containing recommendations and a clear roadmap to optimize and improve the use and value of the platform. Learn more >>
  • fme PlatformAssist – Keep your Veeva platform delivering top performance and value. PlatformAssist is a comprehensive set of modular building blocks that ensure you are at your best through updates, process flow customizations, and daily support issues post go-live. Learn more >>
  • fme SelectAssist – Life Sciences companies face many challenges when selecting new software solutions and platforms. SelectAssist is designed to gather and consolidate requirements, incorporating the perspective of end users, technology requirements, and business goals. We then evaluate solutions and make recommendations for solutions that will meet complex business requirements and gain widespread user acceptance. SelectAssist simplifies software selection for you. Learn more >>
  • fme MetatdataAssist – Effortless metadata updates. Whether before a migration or within an existing repository, MetadataAssist uses advanced AI and NLP (Natural Language Processing) to reconnect lost documents without the frustration, time, or costs to your key business resources. Quickly and efficiently update your content’s metadata to ensure they are properly classified and discoverable in your Veeva system. Learn more >>

Even if you aren’t attending the Veeva Summit, 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.

Contact Us Today!

To learn how fme has earned their place as an end-to-end Veeva partner and to get more details on the conference, contact us today. We’ll schedule a discovery meeting with our Veeva experts to discuss your current challenges and introduce the range of next steps that can accelerate your journey to success.

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

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

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.

Optimize and Improve Your RIM System with HealthCheckAssist℠

Optimize and Improve Your RIM System with HealthCheckAssist℠

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.

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.

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.