In the complex world of medtech compliance, validation is often viewed as a heavy burden. However, with the right technology partner, companies can take a smarter, more efficient approach. Llinos Cooper, Veeva’s services lead for validation strategy, outlines how medtech organizations can leverage a shared responsibility model within the Veeva Vault Platform to reduce redundancy and focus efforts where they matter most.
Cooper emphasizes that validation in the cloud is a layered process involving three parties: Amazon Web Services (AWS), Veeva, and the medtech company. While AWS controls the physical cloud infrastructure, Veeva is responsible for the platform and core software controls. Veeva also executes the installation qualification (IQ) and operational qualification (OQ) for the platform and core applications while validating the “engine” behind the software.
Cooper uses a “lego brick” analogy to visualize this architecture. The bottom bricks are the platform and core applications (e.g., QualityDocs, eTMF), which are validated by Veeva. The top brick is the application configuration—the unique workflows and lifecycles defined by the customer. The customer’s responsibility lies in the user acceptance testing (UAT) of this top layer to make sure the system supports their intended use cases.
Cooper encourages customers to take a risk-based approach by leveraging the validation that Veeva has already performed. That way organizations can focus their UAT on high-level business processes.
Veeva issues general releases three times each year on a predictable cadence so medtech organizations can capitalize on the latest features and functionality that will allow them to streamline internal operations and speed time-to-market. However, this pace also introduces potential challenges because organizations tend to over-validate features, creating a maintenance burden for every subsequent release.
Cooper emphasized that Veeva Vault fits into GAMP 5 Category 4 because it is configurable via a GUI but prevents custom coding, significantly lowering risk compared to custom (Category 5) software and reducing potential validation burden. One way in which organizations can optimize validation efforts is with the ERS trace assessment, available in the Compliance Docs Vault, which traces 21 CFR Part 11 requirements to Veeva’s controls.
Cooper advises medtech validation teams to get involved early so they can understand the system’s architecture. By leveraging Veeva’s pre-executed validation packages, organizations can focus on validating their unique processes rather than the software engine.
This shift from a “validate everything” mindset to a targeted, risk-based strategy, prioritizes compliance while significantly reducing the overhead of initial projects and ongoing maintenance.
Many medtechs like Alcon are already taking this approach. To learn how they’re maximizing their Veeva Vault Platform investment with modern release management and validation processes, read this case study.