Validation Accelerator Implementation Using Valkit for Clinical Tech Vendor

The Challenge

The client, a mid-size clinical technology vendor, offered a configurable software platform to pharmaceutical sponsors but faced a validation bottleneck. Every new client — or software release — required customized PQ documentation, which consumed engineering resources, delayed onboarding, and introduced variability in quality.

The vendor’s baseline IQ/OQ packages were solid but couldn’t scale without a structured way to customize deliverables for each client’s unique configuration and risk profile.

The Systematic Approach

Driftpin implemented a validation accelerator framework using Valkit.ai, a Digital Validation Tool (DVT) that supports master data management (MDM), document cloning, and automated test generation.

We centralized validation variables — such as company names, product versions, configuration settings, and risk levels — within Valkit’s MDM layer. Using this master data, we enabled the client to:

  • Clone existing validation packages for new clients or new versions
  • Automatically generate tailored PQ test scripts based on scoped differences
  • Maintain traceability to the original IQ/OQ baseline and regulatory rationale

This framework aligned with GAMP 5 and CSA principles, enabling a scalable, risk-based approach.

Key Activities

  • Designed and implemented a variable-driven template structure within Valkit for validation artifacts
  • Defined and populated a master data model covering system versioning, configuration, client context, and risk factors
  • Enabled package cloning logic to replicate validation packages by client and/or version
  • Developed logic for delta-based PQ script generation, flagging what must be retested or revalidated
  • Aligned all components with regulatory expectations (traceability, configuration control, documentation integrity)

The Transformation

The client transitioned from custom, labor-intensive validation cycles to a repeatable, scalable framework. Engineering teams were no longer involved in writing compliance documents. PQ packages were generated by non-technical users via Valkit using controlled variables and configuration profiles.

Measurable Outcomes

  • Validation turnaround: PQ documentation delivery reduced from 4–6 weeks to under 7 days
  • Engineering bandwidth: Engineering resource involvement dropped by 80% in validation cycles
  • Compliance quality: Documentation traceability, consistency, and risk alignment improved across clients

Strategic Impact

The client now markets its “Validation-Ready Platform” as a differentiator in the sales process, leveraging Driftpin’s validation accelerator to shorten onboarding timelines. As the client expands into regulated GMP applications, Valkit’s framework supports increased complexity without increasing validation overhead.

This case study demonstrates our CSV validation approach powered by modular frameworks and intelligent automation through Valkit.