Life sciences companies rely on validation lifecycle management platforms to streamline compliance for manufacturing processes and quality systems by centralizing protocols, testing records, and Standard Operating Procedures (SOPs). However, conversations with end users at leading pharma and medtech companies reveal unexpected frustrations driving up time, cost, and risk.
Same Old Process, Same Old Outcome
Legacy DVT tools focus on model-based system definition and requirements traceability, attempting to link specifications, data flows between upstream and downstream processes, test executions, and risk assessments on a single canvas. However, companies often struggle to realize promised outcomes due to the significant manual effort required to populate all the relationships and details in non-intuitive interfaces. Hiring outside consultants becomes mandatory, which in turn drives expenses. Despite sales pitches claiming benefits like seamless traceability, heightened visibility, and risk-based validation, reality often entails toolkit bloat rather than efficient time to value.
Limited Platform Scale or Extensibility
Another major pain point arises when attempting to scale. While vendors promise end-to-end validation programs on a single platform, the actual user experience can be fragile. Companies uploading large volumes of legacy validation documents or data frequently encounter performance issues and random crashing. Integrations with critical systems—such as manufacturing equipment, QMS and ELN software, or content migration from older tools—often fail or introduce bugs, discouraging widespread adoption. In addition, mobile access, custom reporting, or AI-driven process automation are typically scarce or nonexistent—underscoring the rigidity of legacy platforms.
In summary, while these systems initially promise full lifecycle validation modernization and efficiency improvements, legacy DVT implementations often run into architectural friction, customization roadblocks, scale shortfalls, and unreliable production operations. The result is customers mired in extended troubleshooting and expensive remediation, rather than enjoying a true technology partner for innovation.
Time for Leaner, More Adaptable Validation Automation
Global enterprises need a more agile approach to validation—one that is faster to deploy, easier to scale, and flexible enough to leverage new technologies. Modern, lightweight solutions can minimize the manual overhead of linking requirements, processes, and evidence while providing robust automation for day-to-day testing activities.
Valkit.ai offers an immediate return on investment by delivering these advantages right out of the box. Organizations can reduce expenses on lengthy platform customization, minimize disruptions from system instability, and ensure a more transparent, integrated process for managing validation artifacts. Schedule a demo today to experience the least burdensome approach to validation—freeing up resources for genuine innovation and allowing quality teams to operate at peak efficiency.
