System Validation
Client: Mid-Sized Pharmaceutical Manufacturer
Industry: Pharmaceuticals
Location: United States
Project Duration: 4 Months
Services Delivered:
Full Lifecycle Computer System Validation (CSV)
Validation Planning & Documentation
IQ/OQ/PQ Execution
Regulatory Compliance (FDA 21 CFR Part 11, GAMP 5)
Ongoing Change Control Support
SysValiTech was engaged by a mid-sized pharmaceutical company to perform end-to-end validation of their newly implemented Clinical Trial Management System (CTMS). The client needed to ensure the system aligned with FDA regulations and GAMP 5 guidelines prior to a critical audit and product launch.
The project’s goal was to validate the CTMS platform, ensure data integrity, and establish a sustainable compliance framework for ongoing operations.
We followed a risk-based validation methodology tailored to the client’s operations. Our team collaborated with QA, IT, and clinical departments to ensure every validation activity was practical, traceable, and audit-ready.
Key Milestones:
Validation Master Plan (VMP): Defined project scope, system boundaries, and responsibilities
Requirements Gathering: Drafted and approved User Requirement Specification (URS)
Risk Assessment: Identified system functions critical to product quality and patient safety
Testing Protocols: Developed and executed IQ, OQ, and PQ test scripts with deviation management
Traceability Matrix: Mapped requirements to test cases for full transparency
Final Report: Compiled validation summary report and closure documentation
✅ Fully validated CTMS system with audit-ready documentation
✅ Met regulatory expectations from FDA and MHRA
✅ Reduced validation rework by 30% through early-stage risk prioritization
✅ Delivered a change management and periodic review plan
✅ Enabled quicker go-live with minimal disruption to clinical workflows
“SysValiTech delivered with precision and speed. Their structured approach to system validation helped us stay compliant while moving fast toward our product launch. The documentation was thorough and passed our internal audit with zero findings.”