The challenge
The client's traditional computer system validation (CSV) relied on labor-intensive scripted testing and extensive documentation.
Changing regulatory expectations made that model unsustainable. The client needed a more adaptive, risk-based approach.
Our approach
- Applied a risk-based Computer Software Assurance (CSA) framework aligned with FDA guidance, using SQA Solution's CSV 6.0 methodology.
- Ran technical risk assessments to focus validation on high-risk software features, with traceability of critical GxP records and data flows.
- Moved testing from scripted-only to a hybrid model with unscripted exploratory testing and scenario-based demos.
- Matched testing rigor to risk across FDA CSA testing types: scripted, unscripted, ad hoc and error guessing.
- Assessed business process workflows and the end-to-end data lifecycle, applying ALCOA+ to each process and record.
- Delivered new SOPs: Risk-Based Testing, Technical Risk Assessment and CSV Lifecycle.
- Supported adoption with user-focused training, organizational change management and cross-functional workshops.
Results
- Compliance risk reduced significantly from a moderate level.
- Testing rigor applied only where risk calls for it.
- Improved readiness for FDA and EMA inspections.
- Stronger GxP data governance.
“SQA Solution's CSA implementation helped us modernize validation without compromising compliance.”