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) 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. 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.

Preparing for Migration: Critical steps to know

Migration strategy and the path to operational resilience

Over the past few years, an effective digital transformation has been underscored emphatically as a prerequisite for long term business success. Complacency around operational and digital resilience now represents a legitimate existential threat to enterprises in any industry, both from a competitiveness and regulatory compliance perspective.

At its core, digital operational resilience describes an enterprise’s ability to mitigate the risk of spontaneous server outages, rapidly recover from service interruptions and maintain a bird’s eye view of potential systems vulnerabilities. Upgrading to modern solutions and maintaining legacy data in those solutions with an effective data migration strategy is an important aspect of robust digital resilience strategies. This article introduces the importance of an effective migration strategy within a digital transformation process, the approaches being adopted by industry leaders, and best-in-class examples that can accelerate business value.

The link between data migration and regulatory compliance

While data migration has become an integral process in the digital transformation game, it is often overlooked as a core facet of regulatory compliance. Botched or poorly executed data migrations can be catastrophic from an operational point of view – leading to data loss, data corruption and unnecessary downtime – and can also incur heavy regulatory sanctions. If personal data is lost or compromised during a migration, it can result in legal and financial penalties, reputational damage, and loss of customer trust. For example, if a company can’t produce the required documentation for review and approval, it can impede drug certification and undercut revenue.

To add to the challenges, public discourse around data privacy has intensified over the past few years, with new frameworks being implemented to protect users’ Personally Identifiable Information (PII): General Data Protection Regulation (GDPR), the California Consumer Privacy Act (CCPA) and the Data Protection Shield are just some of the regulatory initiatives designed to safeguard user data in recent years. This new regulatory minefield has forced enterprises to rigorously assess their processes for handling and storing user data and has amplified the case for robust data migration strategies when integrating new systems and combining data in corporate merger processes. It is essential that data is held securely and that the processes for protecting that data fit snugly within regulatory parameters. Effectively planning a migration to a new system can also enhance data security, while also ensuring that the data is accessible for deletion in accordance with GDPR stipulations. Additionally, enhanced data control and security can greatly mitigate the risk of data breaches and associated regulatory penalties.

According to a 2022 survey by digital infrastructure company Equinix, complying with data regulations was a top priority within the technology strategies for 87% of US organizations’, with 83% acknowledging IT infrastructure migration to the cloud as a top priority. The groundswell of momentum powering enterprises’ migration to cloud based servers from on-prem physical servers shows no signs of slowing down. We believe that innovative data migration technology will be a key component of successful digital transformations to advanced technologies. Luckily for businesses today, the development of advanced data migration technology is bringing more transparency into the data migration process, giving enterprises a diverse set of tools to choose from to ensure they are well equipped to thrive in today’s frenetic digital environment

Trust proven, consistent experts

The often-ignored truth is that data migration is a complex endeavor that touches multiple departments and roles that need to coordinate tasks, requirements, and timelines. By leveraging innovation partners with demonstrable expertise in the data migration arena, companies can now navigate the migration journey with a greater sense of confidence. To be successful, migration experts and implementation consultants of the target system should have a common understanding of the business objectives. In an ideal scenario, consultants should be available for the entire duration of the project, to ensure consistency of service delivery. Rotating personnel on the project might incur delays as they will need to be briefed thoroughly on the progress or could lead to impaired decision making that doesn’t fully factor in legacy efforts.

Understand your ‘why’

Organizations undertake data migration for a variety of reasons, such as strengthening system security, enhancing customer service capabilities, or driving operational efficiencies. Perhaps a streamlined platform is being implemented to support different business processes, establish a new data warehouse, or merge new data from other sources.

Before any prospective migration program is initiated, there must be a consensus and unified vision from leadership around the desired outcome and goals of the initiative. Irrespective of the initial rationale, the end goal is to have streams of up-to-the minute and accurate data sets which can enable businesses to personalize their services and boost customer retention, while developing a more nuanced understanding of key demographics. In both instances, data should be in the system, either the master data or all relevant registration objects.

In future articles, we will discuss key steps for the preparation phase, and what core considerations should be made before project initiation.

Conclusion and next steps

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.

Webinar: Leveraging the cloud for your business goals

Webinar: Leveraging the cloud for your business goals

This webinar was held on March 29, 2023.  The recording is available here

The best solutions provide organizations with:


One of the biggest benefits of cloud-based technology is scalability. Companies often deal with large amounts of current and historical data, and cloud-based systems allow them to easily scale their solutions as needed, without the need for expensive hardware investments.

Cost savings:

Cloud-based technology can reduce total cost of ownership for hardware, software, and maintenance costs over time. With cloud-based systems, companies only pay for the resources they need, and can adjust their usage to avoid unnecessary expenses.


Cloud-based technology are well-suited to complex integrations across other leading solutions, enabling powerful collaboration with partners, customers, vendors, and other stakeholders. Cloud-based systems provide a centralized platform for sharing data, documents, and other information, bringing together disparate data for more effective decision-making.


Cloud-based technology allows for controlled access to data and applications from anywhere, at any time on approved devices This can be particularly useful for companies with remote employees or partners, as it allows them to work together seamlessly, regardless of their physical location.


Cloud-based technology can provide enhanced security measures that are difficult to implement when integrating legacy systems. Cloud-based systems typically include advanced security protocols and encryption, as well as robust backup and disaster recovery options.

Despite these benefits and their potential impact on achieving business goals, many organizations are still hesitant to make the ‘Big Move’ that allows them to innovate faster, improve agility and responsiveness, and automate time-consuming tasks into efficient and effective operations.
Don’t let yourself fall behind on this critical technology advancement.

Join our Cloud Migration webinar

To get started on your cloud journey, join content experts Generis and fme for an informative webinar to discover the myriad advantages and efficiency gains to be made from migrating to the cloud, and how Generis and fme can provide support throughout the process.

Plus, you’ll hear from migration experts at fme about:
• Challenges with migrations in both complex regulated industries
• A case study of migrating on-premise systems to the cloud
• Why the fme’s migration-center is a proven solution in complex migrations
• Migration-center’s capabilities in both Life Science and non-Life Science regulated industries

This webinar is designed to dispel many of the fears and concerns of migrating complex, regulated companies to cloud solutions, and start you on the first steps of your cloud migration journey. Follow the link below to reserve your place today!