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.

Whitepaper: Essential Steps to a Successful Data Migration

Whitepaper: Essential Steps to a Successful Data Migration

As companies undergo significant changes and upgrade their core systems, ensuring the quality and usability of the data being migrated is paramount to unlocking the full potential of new technologies. We are excited to share practical tips and insights gained from decades of project experience in complex data migrations to help you achieve a smooth and successful transition. Read our Essential Steps to a Successful Data Migration whitepaper to gain invaluable knowledge to support your digital transformation journey.

In this paper we cover:

  • Realistic Scope of Data Migrations: One of the most common barriers to a successful data migration is failure to realistically and independently plan the time required to classify, migrate, and verify the data.
  • Effective Migration Project Phases: It is critical to break the data migration into logical phases that are aligned with the wider digital transformation initiative.
  • The Importance of Validation: Validating the migration is essential to ensure data can be recalled and relied upon as part of business processes, and requirements should be agreed upon from the outset.

Don’t wait – get this paper before your project starts!

In the rapidly evolving digital landscape, it is critical to get the most ROI from your technology investment. This paper outlines invaluable steps to ensure you achieve the full potential of your digital transformation by providing insights and practical strategies to navigate the complexities of data migration. Gain access to expert knowledge that will empower your organization to scope your project properly, craft an effective migration strategy, and plan for critical data validation after your migration. Download our whitepaper today and ensure the first step to unlocking the full potential of your digital transformation journey is successful.

Overcoming Data Migration Challenges: 3 Essential Steps for Success

Overcoming Data Migration Challenges: 3 Essential Steps for Success

All too often, when a heavily-regulated company (e.g. in Life Sciences) puts out a Request for Proposal (RFP) for data migration in line with a major system update, there is a significant mismatch between the work they specify and what will actually be needed to do the job properly.

That’s because moving data across to the new system, and ensuring it’s clean, compliant and optimized to deliver everything that the new software enables, is far from straightforward. It is a major undertaking in its own right, and needs complete buy-in and active partnership from the client side.

The following three tips will help enormously in planning next migrations:

1. Be realistic in your project scoping.

Once Procurement teams and their respective KPIs become involved in the purchasing process (after initial discussions of the project plan and the need for a Class I Project Manager), talk typically moves swiftly to cost and the use of offshore resources.

Yet, this massively undervalues the importance of the data and its integral role in the success of the overall system project. To get the most out of the new system, any imported data will need to be checked, cleaned and enriched so that it delivers as needed, and is fully compliant and can be relied upon to support new operating models – such as IDMP-based Regulatory exchanges, in the case of Life Sciences.

We would always recommend a ‘Best Shore’ approach to data migration, combining the right skills sets and knowledge to do the job as effectively as possible – for instance, with a Class I Project Manager and other strategic capabilities more locally, drawing on other resources on an off-shore basis to fulfil delivery. (We have service locations across the US, Europe, and India.)

2. Understand your role in the engagement – even if you want the external partner to assume the bulk of the work.

It is one thing deciding on the right software for a major system replacement or update, but when it comes to preparing the data to be migrated to it there are all sorts of considerations that need careful thought and communication, which will need the active involvement of the client. This is not about throwing a project over the wall and letting someone else get on with it.

Ideally, for every role that is assigned to an external expert, there needs to be a counterpart internally – from a Project Manager, to business people who can make the time to attend workshops and collaborate with the external service provider on what’s important, who will perform what roles (e.g. enrich the data to ensure its future compliance).

Our experts at fme can take care of every aspect of a migration project – from business consulting and data enrichment, to migration and any system integrations. BUT, this needs to be scoped and resourced appropriately as part of the project plan to keep control of costs and timelines, and ultimately to ensure that the new system project doesn’t fail.

Trying to set a fixed price for a project without first agreeing the parameters is a bit like trying to build an Airfix model without the instructions – a recipe for disaster.

3. Agree effective timelines, based on both priorities and contingencies.

Again, this comes back to the need to be realistic and pragmatic from the outset. This requires total transparency between client and migration partner, and a collaborative approach to the project from the outset.

So, for example, if the reasons behind tight deadlines are to do with a need to be out of a data center by a given date, or are linked to targets and bonuses, it’s important that all parties understand this and can work with those priorities. Often a staged approach to migration can work best, and this can be adapted so that the right elements are scheduled first. Staging can also allow for the reality of team members taking time off for vacations.

Thinking back to projects that have gone off the rails with other vendors can be really useful in all of this. As long as you view your migration/full-service partner as a strategic and integral part of your team, you can’t go far wrong. Speaking for fme, we can bring talent density, knowledge and experience right across the project spectrum – spanning business consulting, technology services, and managed services – as long as all of this has been factored in from the start.

So, let’s start talking.

For more information, please complete this contact form and we’ll schedule a time to discuss your specific requirements.


Essential Steps of a Successful Data Migration

Essential Steps of a Successful Data Migration

When planning a digital transformation with a complex data migration, it’s essential to define the key steps from ideation to execution. Today, we will run through the essential steps for a successful data migration.

When it comes to the migration of data in the life science industry, we are generally dealing with a comprehensive set of sensitive data. This could relate to drug product or medical device registrations, IDMP data, or pharmacovigilance data. Unfortunately, life-sciences companies often underestimate the scope of work involved in a successful data migration. Even when they are convinced that their data is in a good shape, they often discover during the process that the data needs to be enhanced, mapped, or revised. Simply put, they underestimate the effort required for the migration activities in comparison to the implementation of new business applications. After all, a business application is only viable when the data are aligned with the required business processes. For this reason, the migration of data should be treated with the same care as the implementation of the solution itself – clear definition of project scope, strategic planning, detailed monitoring of progress, and a formal quality assurance approach. Each of these components are essential to the complete migration strategy.

Understand the migration scope

Developing a firm understanding of the migration scope is pivotal in terms of setting realistic expectations around timelines and outcomes. Consider a specific scenario in which a company needs to migrate thousands of product registrations from a legacy system to the new system, with the assumption that out-of-the-box custom features will be implemented as well. The business needs to determine which registrations are in the migration scope, and whether there are any products that are retired and outside the migration requirements. Additionally, it must be confirmed if the drug products are for human use or also medical device registrations, and what kind of submission format is involved. Other considerations would include any expectations around the enrichment and the migration of IDMP data, as well as the source of the master data. These are just some of the questions that might arise during the assessment phase and must be clarified.

Furthermore, the business must confirm which entities of data will need to migrate. In the example above, it should be considered how to map registration with the target entities, how the data fits into the master data, and what are the expectations of migrating product registration. Other considerations would be whether to migrate the latest registration status or to build the full history with the appropriate status, and how to migrate variation records that are no longer subject to regulatory inspection.

Scoping of migration should always consider the business requirements to get the project’s whole picture and understand how the source data will be used. It’s important to go through the assessment phase, set the scope at such a detailed level that can be understandable and recognized by all stakeholders, and have the same expectations when delivering the project. The assessment should be carried out by an expert that understands the business processes, knows the migration process and the expectation of the target system.

 Create an integrated plan

After the migration scope is known, a plan of action must be established that follows the migration strategy within the larger digital transformation initiative. It is important to involve all stakeholders in the planning phase and understand the activities of the implementation of the new or upgraded information system. Migration activities should go hand in hand with implementation activities, but the migration project should have its own capability to measure progress separately.

When you need to migrate large amounts of data, you will need to put them in different buckets that should go along with the solution implementation cycles. In most cases, some dependencies give you the order of the migration. For example, migration of the master data can be a separate bucket as they are a dependency of the product registration data migrating. Buckets of data can already be defined in the assessment phase, and this is an important input for the planning phase as well as the data location and quality. The plan should consider all potential downtime and there should be agreement between all stakeholders as to what is the optimal time for data transfer activities. Develop a backup plan for identified risks and make an action plan in case of migration activity failure.

 Validate the migration rules with your experts

Another critical step is defining the migration and testing rules and acceptance criteria. It is advisable to organize workshops with business stakeholders to review, refine and confirm the migration rules proposed by the migration team. At this stage it’s important that the team members also define all essential use cases to prevent data errors in migrated data in the target system.

Ensure the implementation consultant is fully briefed on the migration rules associated with the source data. They can warn you about the gaps, especially if the target solution is not out-of-the-box and some custom fields and features were added. Break the data into a logical subset and build out one category at a time, followed by a dry run using the real data from the migration team in the sandbox environment. This is also the step where the business conducts the mapping and provides any data the target system requires but is missing in the source system. The result of each cycle is the validation of the migration rules, migration scripts for data transition and test scripts.

 Validate the migration

Data migration validation is a very important step as the migration team and the business need to ensure data compliance and have a workable solution. Testing done during the build phase is not sufficient and should be carried out on real data, using the test scripts after the migration is completed. The testing strategy defined at the beginning will provide a framework for validation activities along with resource and time allocations. If the testing approach and scope are not set early enough, it might lead to higher costs, longer timelines and could delay compliance validation and approval. It is advisable to include a test specialist in the building phase to understand the business requirements and the transformation/migration specification. The migration leads should help them understand all the use cases to test, and by engaging with business stakeholders on each cycle, can define the user acceptance testing approach.

 The final migration

After approved validation, the final migration can proceed to the production environment. The migration strategy dictates how the migration will be performed, in one go or incrementally, and how to shut down and dispose of old legacy systems. All stakeholders should agree on when to freeze the legacy system, the downtime of the target system, and communicate how to proceed with the migration of data. Once the migration is complete, a final validation should be executed to prove that the migration was performed in accordance with the validation phase.


Before initiating the project, it is crucial to understand the migration scope, what needs to be migrated, whether the source is one system or several systems, what the data looks like, whether or not data enhancement is expected, what are the business requirements, what is the amount of data (e.g., registrations) and establish a migration plan based on these facts to avoid any surprises later in the project. A critical phase of the project is migration validation, as a lack of quality data in the target system can harm business decisions.

fme has been guiding global pharmaceutical and manufacturing firms through their complex migration journeys for over 20 years. We’ve even developed our own proprietary tool migration-center to enable seamless migrations with minimal downtime. Contact us to discuss your challenges and start your journey on the right path.

Preparing for Migration: Critical steps to know

Preparing for Migration: Critical steps to know

In a previous article “Migration strategy and the path to operational resilience”, we examined the relationship between data migration and regulatory compliance, and the importance for enterprises to create a clear plan for initiating a data migration. Today, we will look at how migration is never one size fits all, and how each company’s migration journey will be different, requiring strategic approaches linked to the complexity of the unique data. There are several key steps to ensure migration initiatives are as streamlined as possible.

  • Understand the project scope: Assessing the quality of data, requirements, and complexity of data will help you set the right migration strategy.
  • Set realistic timelines: The assessment phase will help create an achievable migration plan that includes an ability to clearly measure progress.
  • Define the migration rules with the experts: Allow the migration expert to come out with the migration order and the rules for you to confirm.
  • Validate the migration: Set the testing strategy during the assessment phase. Conduct preliminary testing during the building phase and confirm with the business that all use cases were considered when preparing the test scripts.
  • The final migration strategy: The migration strategy dictates how the migration will be performed, on a one time basis or incrementally, and how to shut down and dispose of old legacy systems.
  • Sanity checks in production: Once the migration is complete, a sanity check on the agreeable amount of migration data should be initiated to prove that the migration is performed in accordance with the validation phase.

Define the scope of the project

Scoping a migration project involves defining the parameters, requirements, and goals of the project, and developing a clear plan and timeline for the migration. It’s also important to define the limits of the project and identify what won’t be included in the current phase.

For example, in the pharma industry, the implementation of the IDMP (Identification of Medicinal Products) standards requires updates, changes, and possibly even the roll-out of a new information system, but this type of agile modus operandi doesn’t always align with the pharma industry’s historically siloed way of working. Nearly every team in the drug development lifecycle – safety, clinical, regulatory, and research and development – can use different, disconnected systems that might not even integrate (e.g. Submission management, RIM, Master data management, Pharmacovigilance, Document management system etc.). Additionally, they are encouraged by the IDMP implementation to apply a single unified, holistic platform that removes silos connecting data and people.

When a decision on the implementation of a new solution and migration is made, it is important to set a clear scope and goal for the whole project. In the context of the implementation of regulatory solutions in the pharma industry, this can be a big deal for the company and the comprehensive assessment of the project is of paramount importance.

Getting started: Plan a data assessment

Before commencing, it is critical to have a clear overview of the project scope, data, and information to ensure efficient planning and execution. Data migration projects in the life science space are often complex, time-consuming and in most cases involve multiple systems and different technology. A clear and comprehensive assessment phase is key to avoiding exceeding predetermined budgets, implementation delays or undercutting business processes. The assessment phase is primarily used to review and assess the data in the existing systems and identify any potential issues and risks that might occur during the project. The purpose of this phase is not to carry out any migration activities, but to benchmark the scope, set recommendations, strategy and ensure visibility for the client. At this juncture, the client should have already known the migration requirements and the expectations for the migration. As a result of the assessment, a decision can be made to go further with the major project after the plan is clear or whether a POC (Proof of Concept e.g. with the migration-center PoC Package) should be performed to assess some more complex data of the migration (e.g. Migration of the drug registration history).

Choosing the right migration approach

Once a thorough data assessment has been carried out, the next step is to decide on the right migration approach. Every company’s data is unique, and the appropriate migration strategy will depend entirely on the quality, value, and complexity of the data. For example, sensitive regulatory data should be handled with particular care. Moving ahead without proper planning will ultimately cause more work in a later phase, and possibly undermine a project’s success. We often recommend businesses to migrate registrations of important products separately and the rest after the go-live, using the same migration rules. This decision can be made if a high volume of data should be enriched, and the business cannot provide them on time. Another important consideration is whether to migrate everything at once – a Big Bang migration – which requires considerable time and resources to complete. Alternatively, businesses can carry out the migration incrementally and transfer data in phases – this is a rolling migration. A big bang can be more straightforward, but a problem with this approach is that no additions or changes can happen during this time, as all data processes are paused during the migration process. An incremental approach doesn’t require as much downtime but can bring more complexity as the source and the target system are run in parallel, eliminating downtime.

 Aligning project & migration timelines

Knowing when to initiate the migration is pivotal. Ideally, the migration should take place in parallel with the solution implementation process, and the development of the migration rules should follow the implementation cycles. For example, when the solution implementation of master data is locked, the definition and development of the migration master data can start and eventually be migrated. After each cycle, the business should confirm the migrated data in the target system and if all the requirements were fulfilled. This approach tells us that we need to understand the whole concept of the project, including the implementation of the solution when building the plan. Otherwise, it is impossible to set all cycles in a logical order and set the right priorities. It is essential that the data migration is carried out in tandem with domain experts that have the technological know-how and strategic acumen to deliver.

Consider a Proof of Concept data migration

Rigorous planning and assessment are critical to the success of any data migration project, and in some instances, a proof of concept (POC) is highly advisable. A POC data migration is essentially a trial run of a larger data migration project, geared towards testing the feasibility of migrating data from one system to another. The purpose of the POC is to demonstrate the viability of the data migration project and to identify any potential issues or challenges that may arise during the actual migration process. When a company is approaching a large-scale data migration, or a high-risk migration involving sensitive or mission-critical business data, a POC can provide significant value.

For a successful POC, it is important that the business provides rich sample data so that the migration team can test and verify the exact processes that will be used in the full migration.  Before running the POC, businesses should:

  • Review sample data sets and consider all use cases
  • Confirm the result of the migration fulfills the requirements
  • Examine and define any gaps and how to fill them
  • Define what work is required if they need to enrich their data

By its very nature, migrating data can be a complex and protracted process, and if not thought out fully in advance, can lead to significant data loss and system downtime unless conducted with a professional migration software. In our next blog, we will highlight the key success factors and best practices for optimized migration.

Contact us to start your migration right

Whatever the reason for the data migration, the goal of all stakeholders is to provide a solution to the business in order to improve business performance and ensure competitive advantage. To achieve this, they should give more attention to data migration and be smarter in the assessment, planning, and migrating data with experts that have experience and knows the business in the life science industry.

fme has been guiding global pharmaceutical and manufacturing firms through their complex migration journeys for over 20 years. We’ve even developed our own proprietary tool migration-center to enable seamless migrations with minimal downtime. Contact us to discuss your challenges and start your journey on the right path.


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.