Are you considering a migration to Veeva Vault Safety? Read our complete guide to learn everything you need to know to make your move successful.
Data migration, although often overshadowed by more glamorous tasks during new system implementations, is undeniably the most intricate aspect. While system configuration and customizations primarily depend on business and functional requirements, data migration carries the inherent responsibility of not only addressing these requirements but also dealing with the complexities of data transformation and anomalies originating from legacy systems. This critical process requires a meticulous approach to ensure a seamless transition and accurate data integration.
The preservation of legacy data presents a multifaceted challenge, encompassing various layers of complexity. These complexities arise from the intricate interplay between the business processes and rules that were enforced by the legacy system(s), as well as the lineage of the data itself. It’s worth noting that certain legacy data might have originated from prior migrations, having been transferred to the current system along with its distinct set of business rules. Any endeavor involving data migration necessitates a thorough examination of the past, present, and future.
Business applications come in all shapes and sizes, encompassing diverse aspects such as data, content, critical processes, and outputs. Within the life sciences industry, one particular type of application stands out as exceptionally complex – transactional pharmacovigilance (PV) systems. These systems not only deal with intricate data structures but also undergo stringent scrutiny from regulatory authorities, placing them alongside clinical, manufacturing, and regulatory systems as some of the most rigorously examined within the industry.
Do you find yourself grappling with issues like delayed submission of adverse event reports, inaccurate aggregate reports, missing cases, or erroneous data? Such occurrences are simply unacceptable. Ensuring the utmost accuracy in data migration is absolutely crucial for maintaining seamless business operations from the first day of implementing the new system. Any discrepancies or shortcomings in this process can have significant consequences and disrupt normal workflow, emphasizing the importance of a meticulous and error-free data migration strategy.
Veeva Vault Safety Benefits and Challenges
Over the years, the landscape of safety systems in the industry has been largely dominated by a select few players, notably the Argus (Oracle) and ArisGlobal product suites. The established players now face formidable competition from emerging contenders, with Veeva taking the spotlight as a prominent challenger. Veeva’s presence in the life sciences sector continues to expand exponentially, and its safety solution, Vault Safety, is gaining significant traction. Veeva’s Vault Safety encompasses a comprehensive range of functionalities, including case intake and processing, ICSR submissions, reporting, and document management for both global and Japanese segments – all integrated within a single platform. Leveraging the same platform as Veeva’s other Vault offerings, such as Clinical, Regulatory and Quality, Vault Safety provides a cohesive and unified solution for organizations operating in the life sciences industry.
The technical environment, represented by the underlying Vault Architecture, introduces a multitude of fresh challenges to safety migrations. These challenges significantly impact various aspects of migration delivery and execution. In an upcoming webinar hosted by Daelight, titled “Best Practices for Migrating to Veeva Vault Safety,” we will delve into these challenges, offering valuable insights into approaches, risk mitigation strategies, and best practices. Join us for a sneak peek into what lies ahead in this brief preview.
Veeva Vault Safety Platform: Why Migrations to Vault Safety Are Different
Veeva’s Vault Safety leverages the cloud-based Vault Development Platform, which is founded on an object-based framework that conceals the underlying database and file management systems responsible for storing data and documents. Consequently, any interactions with the data, ranging from basic queries to intricate batch processing tasks like migration, must pass through this object layer. This architectural approach ensures unified and streamlined access to the data, promoting enhanced efficiency and facilitating seamless integration within the platform.
In contrast, platforms like Argus, ArisGlobal, and others provide direct access to database tables, offering a more open architecture. This enables technical solutions utilizing structured query language (SQL) or SQL-enabled tool suites. This fundamental difference has significant implications for various aspects of a Vault Safety migration.
Migration Requirements: Source-to-Target Mapping
A crucial aspect of any migration process is mapping the data from the source system to the target system. While the fundamental entities and relationships in the safety system have not changed over time (such as Cases, Adverse Events, Products/Drugs, and Reporters), the Vault Safety object model presents some nuances for those responsible for source-to-target mapping. It requires a slight adjustment in terms of comprehending the model’s extensive scope, consisting of thousands of objects and associated fields, as well as engaging in the activities of gathering and documenting mapping rules. It’s comparable to learning a new dialect of a language you are already familiar with, requiring a process of acquainting oneself to ensure accurate and efficient data mapping.
The object-based Vault Platform, in contrast to legacy PV system database-oriented platforms, implements numerous business rules embedded in the overarching architecture. These rules govern not only the user interface but also external inputs, including data migrations, enabled by the Veeva API suite. This architectural approach ensures the enforcement of business rules across the platform, enhancing data integrity and streamlining processes for users.
From a non-technical standpoint, it is crucial to acknowledge that while older systems have adapted over the course of the past 20+ years, Vault Safety, as a new solution, has been meticulously configured to align with the latest regulations set by Health Authorities. It fully adheres to current standards such as E2B, MedWatch, MedWatch devices, and CIOMS, ensuring compliance and seamless integration with the latest reporting requirements.
What implications does all this hold for the migration team? Unlike database-based platforms that lack triggers at the database level for enforcing business rules, the Vault Safety object layer possesses the ability to reject cases migrated from legacy source systems that do not conform to the health rules configured within the system. Consequently, migration analysts should take early measures to optimize the source-to-target mapping phase of the project by undertaking the following steps:
- Gain extensive and in-depth knowledge of the VVS Object model
- Define the target system with a focus on E2B R3 compliance
- Collaborate with other team members to conduct comprehensive source data profiling, aiming to define and document compliance within the framework of E2B R3
In our upcoming webinar, we will take a closer look at all these activities.
Veeva Vault Safety Migration Technical Approaches
Whether it’s safety systems or other areas, migrations are commonly executed through custom coding or established ETL-based tools, with a significant reliance on SQL-based approaches. However, when it comes to migrations to Vault Safety, a distinct combination of technologies is necessary. This entails utilizing specific methods to extract data and documents from the source system and subsequently applying transformations before loading the data into Vault Safety.
It’s crucial to bear in mind that regardless of whether using custom code, commercial tools, or a hybrid approach, the migration process should meet certain qualifications as a minimum requirement. Additionally, in a worst-case where extensive custom code is utilized, comprehensive validation becomes imperative. This entails developing a full user requirement specification (URS) and ensuring traceability, encompassing data mapping specifications, along with other validation artifacts.
An alternative approach involves leveraging a specialized migration tool designed specifically for Veeva Vault, which can accelerate and optimize the process. The Daelight Migration Tool (DMT) is a notable example of such a solution. It is a validated platform widely utilized across various domains, including Vault Clinical, Quality, Regulatory, and Safety. In our upcoming Vault Safety migration webinar, we will closely examine this solution, providing valuable insights and a deeper understanding of its capabilities.
Planning a Veeva Safety Migration
Once again, the planning phase of a migration project assumes new significance due to the object-based architecture of Vault Safety and the incorporation of business rules compliant with Health Authority standards within this framework. We have already explored the new perspective required to address migration requirements and analysis, along with the technical approaches involved. These factors must be diligently incorporated into the overall migration effort, effectively planned, scheduled, and monitored through efficient project management practices. Additionally, ensuring optimal migration performance is another crucial aspect that should not be overlooked.
In simple terms, when compared to SQL-based database-to-database migrations, the load process ((the “L” in the Extract-Transfer-Load (ETL) pattern)) in Vault Safety will require considerably more time. This fundamental understanding needs to be taken into account while creating the migration plan and timeline, as it impacts the scheduling of migration dry-runs and, more importantly, the production migration itself. Strategic considerations are crucial to ensure minimal end-user downtime during the migration process. We will delve deeper into this topic during the Veeva Vault Safety webinar, providing valuable insights and practical guidance on managing the load process effectively.
Embarking on a migration journey to Veeva Vault Safety is a very different endeavor that differs from previous experiences of companies. The object-based platform necessitates a shift in mindset when it comes to planning, requirements gathering, technology selection, and execution. We invite you to join us at our webinar, where we will share valuable insights and proven tactics to overcome the challenges associated with Vault Safety migration.
Daelight Solutions is a Veeva Preferred Services Partner and Certified Migration Partner that helps organizations migrate to Vault Safety. Contact us to learn more about how we can help you make a successful move.