Computer System Validation (CSV) Services
Validated Systems. Assured Data Integrity. Global Compliance—Delivered with Trusted Lab Partners
In regulated environments, your data is only as reliable as your systems.
We provide end-to-end Computer System Validation (CSV) services, leveraging qualified partner laboratories and technology providers to ensure your systems are compliant, secure, and inspection-ready.
Our CSV Services
Validation Strategy & Planning
- Risk-based validation approach
- Validation Master Plan (VMP)
- System classification and GAMP-based strategy
CSV Documentation & Execution
- User Requirements Specification (URS)
- Functional Specifications (FS) and Design Specifications (DS)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
Data Integrity & Compliance
- Implementation of ALCOA+ principles
- Audit trail review and controls
- Compliance for electronic records and electronic signatures
Partnered Lab & System Validation
- Validation of systems used in partner laboratories and CROs
- Vendor assessment and qualification
- Oversight of third-party systems
Cloud & SaaS System Validation
- Validation of LIMS, ELN, eQMS, and other digital platforms
- Vendor documentation review
- Periodic review and lifecycle management
Audit & Inspection Support
- Mock audits and gap assessments
- Inspection readiness support
- Assistance during regulatory inspections
Systems We Validate
- Laboratory Information Management Systems (LIMS)
- Electronic Lab Notebooks (ELN)
- Electronic Quality Management Systems (eQMS)
- Clinical data management systems
- Pharmacovigilance systems
- Manufacturing and analytical software systems