SQA Solution partnered with a top-tier pharmaceutical company to transform their traditional Computerized System Validation (CSV) practices. By implementing a risk-based CSA framework aligned with FDA guidance, the organization reduced documentation burden, enhanced compliance, and accelerated validation cycles across global operations.
Strategic Approach by SQA Solution
SQA Solution implemented a scalable, FDA-aligned CSA framework through the CSV 6.0 methodology, which included:
- Risk-Based Validation Methodology
- Conducted in-depth Technical Assessments to prioritize validation efforts on high-risk software features.
- Ensured full traceability of critical GxP records, processes, and data flows aligned with ALCOA+ principles.
- Optimized Testing Strategies
- Transitioned from scripted-only testing to a hybrid model integrating unscripted exploratory testing and scenario-based demos.
- Implemented minimum required testing rigor per risk level using FDA CSA testing categories: scripted, unscripted, ad-hoc, and error guessing.
- Comprehensive Data Integrity & Lifecycle Management
- Executed detailed Business Process Workflow and End-to-End Data Lifecycle Assessments.
- Applied ALCOA+ standards (Attributable, Legible, Contemporaneous, Original, Accurate) across each process and record.
Implementation & Deliverables
- Developed and rolled out new SOPs: Risk-Based Testing SOP, Technical Risk Assessment SOP, and CSV Lifecycle SOPs.
- Delivered user-focused training programs and organizational change management (OCM) strategies.
- Conducted cross-functional workshops to foster adoption and minimize resistance.
Pre vs. Post CSA Implementation
| Metric | Before CSA | After CSA by SQA Solution |
|---|---|---|
| Documentation Volume | High | Reduced by ~40% |
| Validation Cycle Time | 6–8 weeks | 3–4 weeks |
| Testing Approach | 100% Scripted | 60% Exploratory/Unscripted |
| Compliance Risk | Moderate | Significantly Reduced |
Client Feedback
“
SQA Solution’s CSA implementation helped us modernize validation without compromising compliance. Their expert-led approach improved efficiency and audit readiness.
– Sr. IT QA Manager, Global Pharma Company
Key Outcomes
- Faster Time-to-Validation: Shortened validation timelines while improving quality.
- Right-Sized Testing: Leveraged test rigor only where necessary, avoiding over-validation.
- Regulatory Confidence: Enhanced readiness for FDA and EMA inspections.
- Improved Data Governance: Robust handling of GxP data across systems and processes.
