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

Veeva 23R1 Update: New and improved for Spring ‘23

Veeva 23R1 Update: New and improved for Spring ‘23

Veeva’s 23R1 release is slated for April 21st release to all Vaults. As always, there are many new features and enhancements available in the new release, some of which require configuration efforts to enable in your Vault. fme is your partner in keeping your Vault up to date on all the latest improvements and functionalities. Let’s review some key new features which require configuration effort and their potential benefits included in this release for the Vault platform, Veeva Vault QMS, and Veeva Vault RIM.

Vault Platform features

Multi-Record Workflow

With the last release in 2022, Veeva introduced the ability to route multiple records (i.e. Change Control, Quality Events, Audit records, etc.) on the same workflow at the same time. This is similar to how multiple documents can be routed for review or approval on the same workflow via the Cart

In 23R1 the ability has been added to remove records from a multi-record workflow based on defined conditions. For example, if some records have incomplete fields, they can be removed from the workflow based on the defined criteria to ensure that only complete records are routed in the workflow. This action will be reflected in the audit trail.

Additional workflow configuration refinements are available in 23R1 to limit the roles allowed to participate when a workflow initiator selects the users for a participant group. This ensures the person initiating the workflow can only select users to participate in the workflow who have the correct user role(s).

Interface enhancements

A few of the new features in 23R1 provide interface enhancements for the system users. Tab Collections can now be created based on the user’s system permissions. This option can enhance a user’s experience in the system by providing an additional organization level for how information is displayed and accessed.

Another great enhancement that can head off frustration in users is that multi-select fields can easily be ordered alphabetically. Previously this required that a ticket be submitted to Veeva Support to configure.

Veeva QMS

In Veeva Vault QMS, several new features provide additional functionality to users if configured in the Vault.

The ability to perform and document a 5 Whys Analysis can assist in root cause analysis (RCA) of Quality Events or Complaints. Using the 5 Whys Analysis methodology, a Root Cause is identified by identifying a problem statement and iteratively asking ‘why’ the issue occurred up to five times. This is known to be a very effective RCA tool, and in 23R1 functionality has been added for this process to be completed and documented within Vault. Once the Root Cause Analysis reaches the Complete state, Root Cause records are automatically created by Vault.

Improvements are also available to the Risk Management functionality, which will allow users to enter data quickly and easily for risk events via the new Risk Builder Tool when performing PFMEA assessments. This feature makes it easy to enter multiple risks for a single risk assessment and allows for these risk items to be evaluated simultaneously.

There also are new features to automate tasks in the Vault. Configuration can be added for Vault to automatically create the associated Proposed Audit records based on the Planned Start Date and Planned End Date of the Audit Program. Vault QMS also now supports the ability for automated intake of supplier change notifications received via email within Vault. This facilitates triaging the change notification and assessing for impact while bypassing the need for manual input of the change notification details. In addition to the Vault configuration activities, some additional configuration on your email server will be required from your internal IT team.

Finally, the Recurrence Check capability in QMS can be used for custom Quality Event object types, not just the standard out-of-the-box Quality Event types. This enhancement will, once configured, allow your business to identify recurring events for all Quality Event object types.

Vault RIM

In RIM Registrations the Registration Verification workflow can now be reconfigured as a multi-record workflow as well so that multiple records can be routed on the same workflow in parallel, similar to the multi-record workflow described for Vault Platform.

In RIM Submissions, several improvements to Content Plan functionality have been made available.

  • A feature can be enabled to allow users to create a Report Level Content Plan by copying from an existing Report Level Content Plan. The action copies the Content Plan, Content Plan Items, and the matched documents.
  • A new field can be added on Submission, Event, and Constraint objects to allow for more granularity for excluding and creating Content Plan and Content Plan Item records as inactive based on the selected criteria.
  • Also, a new Update Content Plan Study Section action is available for configuration. This action moves valid study sections related to the Submission Clinical Study or Submission Nonclinical Study within the Submission Content Plan to a new location when Clinical Study Type or Nonclinical Study Type fields are updated.

In RIM Submissions Archive a new useful feature that can be configured is the ability for Vault to display a special styling when sections are empty in the new Submissions Archive Viewer that was launched with 22R3. This will provide a visual cue to the user that Submission sections do not contain content. The functionality is also available for users to select and view inactive Applications and Submissions in the new Submissions Archive Viewer.

Learn more about Veeva from fme

These are some of the interesting new features available in the Veeva 23R1 release. Contact fme for details on additional changes that could impact your environment, and for assistance in configuring, validating, and promoting these changes to production.

About the author

Amanda Hancock is a Principal Consultant with the Life Sciences business unit at fme US. She has over 20 years of experience in the Life Science industry, working in the clinical research and diagnostics sectors. Amanda started her career in 2000 as Research Assistant at The Ohio State university and later worked in the roles of QC Analyst, Quality Assurance Manager, and Quality Assurance Director before joining fme in 2022. In addition to being a Certified Quality Auditor (ASQ), Amanda is a Veeva Vault trained professional holding Associate Administrator certifications in Veeva Vault Platform, Veeva Vault QualityDocs, Veeva Vault QMS, Veeva Vault Submissions, and Veeva Vault Submissions Archive.

Smoothing the road to RIM transformation with Veeva

Smoothing the road to RIM transformation with Veeva

Putting data integrity first in digital transformation

So much of the value of pharma R&D companies is in the data they produce and own. Yet when embarking on digital transformation programs – such as regulatory information management (RIM) migrations using a modern platform such as Veeva – many organizations overlook the work that will be involved in preparing legacy data so that it can be used optimally and confidently in the new system.

As many terabytes of information are moved across to the new platform, very real challenges around that data’s quality, integrity, completeness, and fitness for future purpose can arise. And unless these issues are addressed ahead of or as part of the migration, the new platform will never be able to deliver to its full potential.

Making smooth work of data migration for a mid-sized global pharma R&D company

In a recent client project that I worked on with Veeva and data migration specialists fme, the need for foundational data work was recognized and provided for up front. This had a direct bearing on the successful implementation and outcomes of the new Veeva RIM system.

The company, a global, mid-sized pharma organization, was embarking on a major international program to modernize its Regulatory documentation and submission management capability, which would require extensive content mapping and data enrichment.

fme brought immediate value here, able to fill gaps in the client’s internal knowledge. For instance, fme had expert knowledge of the target Veeva system, being a certified Veeva partner, and of the scope of the data clean-up, preparation, augmentation/enrichment, and validation that would be required.

Containing any risk with the fme migration-center

Crucially, fme was able to call into play its migration-center. This is its own proprietary platform for high-volume and complex content migration. The fme migration-center allows all the data verification and preparation work to happen in a ‘safe’, validated environment without disrupting the primary, live Regulatory Affairs system. The dedicated toolkit takes care of all the translation work by working on a series of ‘deltas’ – for example, starting with historical and fairly static records, then progressing to data that is still changing. This carefully honed process for data extraction plays an important role the minimizing risk of large-scale data migration work.

fme’s tools and experience reduced migration time by a third

The result of all this meticulous work, the vast majority of which was able to happen safely offline, was that the total migration took just 12 months – a whole six months faster than anything I have experienced previously in my two decades of large system implementations. Certainly nothing so comprehensive, involving such vast volumes of data and such extensive data translation and augmentation. The speed was quite phenomenal.

Importantly, it isn’t just the level of technical expertise that fme brings to such projects that sets the company apart. It’s also the consultants’ knowledge of Regulatory processes and data in Life Sciences, and their ability to bridge technical and business teams in getting across what needs to be done.

A certified partnership

As I said at the outset, data is probably THE most valuable asset a pharma R&D company possesses, so upholding its integrity and securing its long-term potential is absolutely critical.

For the global client, the new global Veeva system went live as planned and was hugely successful. It is one of many data migration projects fme has worked on with Veeva, whose platform today is the industry standard in Life Sciences for RIM modernization.

One of the hallmarks of fme’s work is the close relationship its consultants form – with Veeva, with the client, and with any other consultants who may be involved (in this case, me). Nothing is ever ‘thrown over the fence’; ownership of the project success is very much shared and respected.

I now work regularly with the specialist team at fme and, thanks to the meticulous planning and attention to detail which comes from such deep experience and subject matter expertise, our projects are among the smoothest I have ever witnessed.

Get started, risk free

Don’t let your migration start off down the wrong path. Set the right direction by taking advantage of a free 30-minute analysis with our Life Sciences expert and Business Unit Director, Ian Crone. His unique combination of sector understanding and technological knowledge give him an unparalleled perspective on the possibilities and pitfalls inherent in complex transformation initiatives in this complex and highly regulated industry.

About the author

Guest author Jon Sanford is an independent regulatory/RIM expert at Rubus Ilex. He has worked in the field of Regulatory Operations for two decades and has over 30 years’ pharmaceutical experience, which has included managing a team of Regulatory Operation professionals responsible for publishing regulatory dossiers across Europe and Asia and Latin America. He has also been the business lead on a number of Global Document Management Systems, Regulatory Publishing Systems and RIM implementations.

Evaluating and optimizing security and permissions in Veeva Vault

Evaluating and optimizing security and permissions in Veeva Vault

One key benefit of the Veeva suite of solutions is that security and permissions are pre-configured to support the solution and highly configurable. This is great for your company from a compliance standpoint, but it can also introduce complexity that can be difficult to manage if not planned effectively from the beginning. You need to ensure that your users can access the correct data at the appropriate stage in the process, but you also need to protect and control that data to ensure that only authorized users have that access.

User access is a critical area to understand thoroughly as it impacts every area of your compliant, validated solution.  So how do you manage it? Is there an internal team who has the skill, time, and knowledge to understand each layer of the access approach? Or are you using the approach of “well, the vendor validated this, so it is probably fine…”? Over many projects, fme has developed and refined a controlled and systematic method for assessing, planning, executing, and testing your user’s data access permissions to ensure you are in control of the access to your data, and get the most of the Veeva solutions.

Let’s take a look.

Assessment: Understand your permission set requirements

The first step is to get a detailed understanding of the permissions you will need. Your administration team and process owners should evaluate your existing structure to determine if the current licensing model and security configurations are working efficiently for your company. Review the following areas to identify opportunities:

  • Security Roles define the specific access allowed in the system for each user
  • Permissions Sets allow granular access to data and content
  • User Roles dictate the roles automatically assigned to user depending on scope (for example: Approver role for a specific department)
  • Lifecyle permissions determine which User Roles have access or can perform specific functions at different points in the document/record lifecycle
  • Possible integrations to automate the user profile creation and management process

As you know there is a lot to consider here! You are looking for any gaps, overlaps, or conflicts between these areas.

Planning: Define required permission sets

With a clear understanding of the existing permissions settings and requirements, you can start to build a comprehensive permission matrix detailing who needs what level of access in each area. It is important to consider which user roles require holistic data access and which users’ roles require lifecycle-state-specific access. Access should be managed to allow completion of work responsibilities while also ensuring necessary oversight of sensitive materials.

In fme’s projects, once we identify existing improvement opportunities and develop a full permission matrix, we test the configuration changes to verify the defined requirements are met. We then review the recommendations and key benefits with the team leadership to determine the path forward. We work within your change management requirements to ensure control of the overall impact to users, training materials, in-progress workflows, and existing content. We document all this information in our Implementation Plan.

At the end of your planning process, you will have a robust, methodical Implementation Plan that your company can leverage within your change control and validation processes. This plan should also have provisions in place for future change. No system is static forever, so be sure to build in a controlled revision process for additions, edits, and deletions as you continue to grow and evolve.

Implementation Phase

After the plan above is agreed upon and ready for execution, it is essential to configure and fully test the updates in the validation environment. Review your permissions matrix and ensure that every point is tested for both what is allowed and for what should not be allowed . Do approved users and roles have access, and are all others blocked? Use your documentation to plan your testing to make sure your business needs are met. If you discover any issues or required adjustments, be sure to correct the issue, retest, and add the changes to the plan in a trackable process.
We’ve seen many first-pass configurations work perfectly until ‘white-hat’ testing exposes unexpected access allowed in critical areas. In fme’s methodology, we start with clearly defined documentation of what will be maintained, updated, or eliminated based on the approved plan. We then execute rigorous testing to verify that the changes provide the desired results. The test results are then summarized, documented and approved by our client team. With these changes tested and approved in the validation environment, we then plan and execute the same process for the production Vault.

Post Implementation Phase

Other elements that are often given minimal attention include training, post-implementation monitoring, and verification. Take the time to confirm the change is adopted smoothly by the end users, and all members of the admin team understand the changes and the reasons for them. Provide written procedures to ensure that optimized settings and profile assignments continue to be utilized as planned. Any additional changes should always be documented, reviewed, and approved.

With any change within complex systems, there are always unexpected combinations of variables that provide unplanned results. Don’t assume everything will go perfectly and plan some time for real-time fire drills and critical adjustments. If you do everything perfectly and don’t need that time, super! But if you do, you’ll be thankful you have the room for it.

When we work with our customers, we agree upon a specific period of post-implementation support to address any challenges encountered with the changes in production. We also train both users and admin teams, providing detailed documentation that can be referenced at any time. Beyond the end of the current project, we maintain a consistent communication cadence, so we are available for further updates or planned changes down the road. We also recommend periodic reviews to verify that established configurations match your evolving needs, and there are no outstanding changes waiting to be made. Our customers appreciate that we document and leverage the system and process knowledge gained during our engagements to help streamline future projects .


Permissions and access control are basic components of any system and should always be given appropriate attention. Ensure your team has the experience to consider all situations so you don’t leave security concerns and questions unanswered. These challenges will multiply over time if not addressed. With a complete permission structure defined that meets your specific business needs, you will ensure that your users have access to the data and workflows they need to do their jobs.

If you have any questions or concerns, please reach out to fme’s team of Veeva certified configuration experts to help you with your security management. Our proven step-by-step approach will show that it’s possible to leverage the robust configurability of the Veeva solution to serve your user and compliance needs with a consistent framework that is replicable for future business scenarios.

About the author

Amanda Hancock is a Principal Consultant with the Life Sciences business unit at fme US. She has over 20 years of experience in the Life Science industry, working in the clinical research and diagnostics sectors. Amanda started her career in 2000 as Research Assistant at The Ohio State university and later worked in the roles of QC Analyst, Quality Assurance Manager, and Quality Assurance Director before joining fme in 2022. In addition to being a Certified Quality Auditor (ASQ), Amanda is a Veeva Vault trained professional holding Associate Administrator certifications in Veeva Vault Platform, Veeva Vault QualityDocs, Veeva Vault QMS, Veeva Vault Submissions, and Veeva Vault Submissions Archive.

Digital transformation with Veeva? Choose a Certified Partner that can do it all

Digital transformation with Veeva? Choose a Certified Partner that can do it all

Veeva certification: Our annual commitment

Veeva has 3 releases each year, and it’s a requirement that any Veeva partners re-certify each year to ensure 360-degree familiarity with the most recent updates. This is a big commitment for any company to make to support the platform, but it ensures that Veeva implementation and service partners will be able to provide the highest level of knowledge and support for Veeva customers.

To keep up-to-date with the features and opportunities associated with the evolving product suite, fme’s over 30 Certified Professionals maintain their skills and certification with the following courses, and verify their knowledge with final exams that can take an additional three hours to complete.

Vault Platform – Associate White Belt Exam (live lead courses)

  • Vault Platform Fundamentals Pre-work (4 hours)
  • Vault Platform Fundamentals (4 hours)
  • Vault Business Administrator (5 hours)
  • Vault System Administrator (11 hours)
  • Vault Platform Workflow & Security Fundamentals (5 hours)
  • Vault Document Workflow & Security Fundamentals (6 hours)
  • Vault Document Workflow & Security Fundamentals (6 hours)
  • Vault Platform Data Load & Configuration Migration (5 hours)

To extend the validity of the certification, it’s necessary to pass the latest Veeva Release Training and Exam, covering both topics linked to the recent releases and the Veeva Vault Platform as a whole.

Other Life Science-specific Veeva certifications

For a specific Associate White Belt for specific solutions (QualityDocs, QMS, Submissions etc.) there is a Vault Platform Associate White Belt Exam that also needs to be renewed each year.

Vault QualityDocs Associate White Belt

As for the wider Veeva Vault Platform, specific live lead courses need to be completed, including:

  • QualityDocs Fundamentals & Business Administrator (2 + 4 hours)
  • QualityDocs System Administrator (4 hours)

Vault QMS Associate White Belt

  • QMS Fundamentals & Business Administrator (2 + 4 hours)
  • QMS System Administrator (4 hours)
  • Vault RIM Submissions Associate White Belt
    • Submissions Fundamentals (2 hours)
    • RIM Suite Domain Overview Pre-work (3.5 hours)
    • Submission Fundamentals Pre-work (3.5 hours)
    • Submissions Business Administrator (8 hours)
    • Submission Business Administrator Pre-work (5 hours)
    • Submissions System Administrator (8 hours)

Vault RIM Submissions Archive Associate White Belt

  • Submissions Archive Fundamentals (2 hours)
  • RIM Suite Domain Overview Pre-work (3.5 hours)
  • Submissions Archive Business Administrator (4 hours)
  • Submissions Archive System Administrator (4 hours)

fme is your Veeva Certified Partner

Whether you’re implementing Veeva for the first time, or bringing across more content to the platform, fme – a longstanding Veeva Certified Partner for both technology and services – is the ideal choice to manage all your integration and data migration needs. That’s thanks to:

  • Our deep experience. fme was founded in 1995 with a core team of digital transformation experts and has continued to grow to a global presence with offices in Germany, Romania, and the United States of America as well as operations in India. We integrated the Veeva product catalog into our offerings in 2020 and expand our partnership each year.
  • The scale of our resources. We have over 30 Veeva Certified experts working across our client projects at any one time, with a team of experts in OpenText, Generis, and all major platform solutions.
  • Our deep Life Sciences knowledge. We have deep experience with Veeva solutions across all kinds of Life Sciences use cases. We understand your functional and business needs, and have solved many of the most complex challenges in the industry.
  • Our extensive legacy system knowledge. We have in-depth knowledge of the environments that Veeva adopters are moving from, so we have unique insights into how to ensure a migration project achieves its goals the first time, on time, minimizing down-time and workflow interruptions.

Our tested and proven holistic approach, as well as our commitment to an efficient, cost-effective deployment and migration, will decrease your TCO while increasing your technology ROI. We know both the pitfalls and potential of effectively integrated solutions, and can help you plan, implement, migrate and maintain your technology environment. We can also take care of all aspects of business analysis, data validation, data clean-up, and data enrichment – all critical tasks as part of the digital transformation and business accelerating process.

fme’s proprietary migration-center

As service partner, we understand the power and potential of Veeva’s solutions, but the fme team takes it a step farther; we are also a Veeva Technology Partner. To provide the most efficient and error-free transformation to the Veeva platform, we’ve built Veeva natively into our migration-center migration tool. Continually refined over the last 16 years of global migration projects, migration-center is our proprietary tool that allows clients to migrate, consolidate, archive, decommission and flexibly coordinate all of their stored data and documents saving 60% in costs and 80% in project duration, all without impacting daily business operations. It simplifies migration from any platform to Veeva solutions and is not offered by any other provider. Learn more at

Work with the Veeva experts

As a leading Veeva Certified Partner with extensive life sciences experience, fme can help you plan, implement, and migrate to this powerful platform with confidence, speed, and ease. Contact us to get started.

For more information, please complete this contact form and we’ll schedule a time to discuss your Veeva-related challenges and solution options.

Managing CRO Sponsor Compliance in Veeva Vault Clinical

Managing CRO Sponsor Compliance in Veeva Vault Clinical

We also highlighted the importance of having a full picture of your outsourcing strategy as a small-to-midsize clinical research Sponsor. The activities to be performed and the systems of record to be utilized by the Contact Research Organization (CRO) drive our approach for oversight and governance – the essential compliance aspects of eClinical systems in the clinical operations space.

For example:

  • Will the CRO use their in-house eTMF system, work exclusively in the Sponsor eTMF, or a combination of the both?
  • Will the CRO systems/reports integrate with the Sponsor CTMS to capture enrollment metrics or other pertainant, strategic clinical data points?
  • What is the cadence of document and information sharing expected (i.e. Quarterly, Annually, End of Study)?

With this healthy foundation – simplicity and awareness – we are primed to tackle two key components of long-term eClinical system success: oversight and governance.

Oversight doesn’t have to be a complex process

First, let’s box in exactly what a Sponsor is obligated to under the FDA requirement of ICH E6, Section 5.2:

5.2 Contract Research Organization (CRO)
5.2.1 A sponsor may transfer any or all of the sponsor’s trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The CRO should implement quality assurance and quality control.
5.2.2 Any trial-related duty and function that is transferred to and assumed by a CRO should be specified in writing.

The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor’s contracted CRO(s).

Put simply, the Sponsor must ensure that there is appropriate oversight and the evidence of the oversight needs to be retained. If the CRO didn’t do something or didn’t execute in the agreed upon manner or timeframe („specified in writing“ as required in 5.2.2), the Sponsor continues to bare the risk for the breach or underperformance.

As we can see in 5.2.1 of ICH E6, the CRO does have an obligation to implement (1) quality assurance and (2) quality control measures; as the Sponsor, these are our items of focus for oversight.

Is the CRO executing in alignment with these things:

  • Quality Assurance – the overarching quality management concept that relates to how a process is to be performed, and uses a proactive approach to prevent quality issues from arising
    (i.e. work instructions, process checklists, standards to be met in order to approve a document)
  • Quality Control – a reactive measure used to detect defects/deviations from defined processes and the steps taken to capture (documentary evidence of issue identification process and remediation steps) and correct any issues
    (i.e. mock inspection, QC Review workflows, logging Quality Issues on documents and routing for remediation).

Now that we know what is required, let’s talk game plan. Oversight doesn’t have to be a complex process – just set the cadence, determine the sample size, and, like your 3rd grade math teacher used to say, no points awarded unless you show your work!
Start with what is feasible, given the applicable outsourcing model and regulatory history of the organization (annual, staggered with Veeva Vault releases (3x yearly), etc.). Determine the subject matter to be reviewed and create a simple, user-friendly format to capture CRO oversight activities. This should include the remedial measures taken to correct any issues; to follow through with those measures is key, and should be incorporated into the next round of CRO oversight (if not completed sooner).



How to create a simple, painfree governance framework

Governance can be an intimidating concept! Given Veeva‘s 3x annual release schedule and associated impact activities for each one, where do you even start? The most common challenge that small-to-midsize organizations face is optimizing limited resources – how do you find the time to develop a strategic system management plan, create structure and process to support that vision, and then, actually execute on it?

The good news? In the exasperation, is the answer.

Let’s break it down:

1. Develop a strategic system management plan.

a. What we do now

i. CRO Oversight
ii. Veeva Vault Releases
iii. Program-Level Support

b. What we want to do 1 year from now

i. CRO Oversight
ii. Veeva Vault Releases
iii. Program-Level Support

c. What we want to do 3 years from now

i. CRO Oversight
ii. Veeva Vault Releases
iii. Program-Level Support

2. Create structure and process to support that vision.

a. What are we doing now that works?
b. What are we doing now that doesn’t work?
c. What needs to change to get us to the Year 1 goal?
d. What needs to change to get us to the Year 3 goal?

3. Execute on it.

a. Start with what is within your control. Lay the groundwork to persuade others toward your future vision, then embrace the evolution of the strategic vision.

By answering the above questions, you’ll create a simple, painfree governance framework; a good foundation from which to build and mature, tailored to your organization‘s specific goals and needs. And, if task 2 „Create a structure and process to support that vision.“ was a tricky one, not to worry. We’ll dig deeper into that specific topic in our upcoming blog post: „Data Discernment – A simplified approach to strategic planning“ – stay tuned!