Digital Validation for Technology Vendor

The Challenge

Our client, a GxP, SaaS manufacturer consistently faced project overruns when customers couldn’t complete their PQ testing on schedule. Since the system could not go live until that step was complete, our client was on hold until it was executed. As a result, implementations exceeded timelines and budgets while tying up our client’s resources on extended go-live cycles.

The Systematic Approach

We established a risk-based validation approach, built on CSA and GAMP that accentuated risk management and critical thinking. In addition, we introduced Valkit.ai (Valkit), a DVT that enables a robust, extensible platform for all validation activities. In addition to establishing a paperless framework for all validation deliverables, ValKit utilizes agentic AI components for autonomous requirement mapping, intelligent test script generation, and proactive risk assessment.

This platform, in conjunction with Driftpin’s help in devising and documenting a new strategy for computer system validation, allowed our client to significantly reduce its IQ/OQ validation timelines, but most importantly, it allowed them to generate PQ scripts on a per-client basis, which they then could provide to the customer to accelerate the final test execution step.

Further, by leveraging Valkit’s cloning capabilities, our client was able to quickly move from customer to customer, setting their configuration and generating their dedicated PQ scripts. The ability to work at scale allowed the client to determine if the PQ scripts were offered as part of implementation or were utilized for revenue generation.

Key Activities

  • Implemented and migrated our client’s existing validation process and deliverables onto the Valkit platform.
  • Imported, analyzed, and updated existing system URS
  • Imported, analyzed, and modified existing IQ and OQ test scripts
  • Established platform repository for controlled doc and for collection and storage of artifacts and documented evidence.
  • Created document review and approve practice, with proper sequencing and priority
  • Established systematic quality review processes for validation package delivery
  • Built frameworks for rapid client environment assessment and scope definition

The Transformation

Our client now delivers validation packages in weeks rather than months, with engineering teams focused on product enhancement rather than repetitive compliance documentation. They have updated their processes to depend on valkit as the scale of their validation has increased. New client onboarding follows predictable processes with consistent quality standards.

Measurable Outcomes

  • Validation delivery: Validation delivery timelines: months → weeks
  • Streamlined and Well-documented Test Artifacts: Test execution, data collection, documented evidence assembly, and deviation handling are now clear, consistent, and accurate
  • Engineering focus: Automatic management of validation documentation overhead frees development to focus on product development priorities
  • Client satisfaction: Attaining agreed upon go-live dates and removing the customer from the focus on validation delays has increased customer satisfaction drastically.

Strategic Impact

Systematic validation capabilities became a competitive differentiator, enabling faster enterprise sales cycles and more predictable resource planning while maintaining full regulatory compliance.

This case study demonstrates our CSV validation approach to creating scalable compliance delivery for technology vendors.