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Computer System Validation Services
Computer Systems Validation, Testing, And Compliance Services: If you are seeking computer system validation experts, look no further. Xybion has demonstrated expertise validating computer programs for all types of regulated businesses in the energy, transportation, financial services, and life sciences (including FDA-regulated businesses such as pharmaceutical and medical device manufacturers, clinical research organizations, and GLP laboratories).
We offer a global experience to oversee GxP or other compliance standard needs from our headquarters in the United States or offshore in our Global Delivery Center in Chennai, India.
Xybion experts have a thorough understanding of federal regulations and industry-accepted software development standards. Our clientele is comprised of industries regulated by the FDA, FCC, IRS, and SEC. We utilize a five-step process for all computer system validation projects:
- Draft and Approve SLC Documentation
- Execute Test Protocol & Validation Scripts
- Document
- Closeout & Summary Report
- Review & Approve
- Project Management
- Software Development Life Cycle
- Gap Assessments
- Risk Assessments
- Validation Master Planning (VMP)
- User Requirements Specifications (URS)
- Functional Specifications (FS)
- Design Specifications (DS)
- Design Review
- Data Archiving
- Continuity Planning
- Change and Configuration Management
- Incident and Problem Management
- Periodic System Reviews
- Best Practices
- Leveraging of Vendor Documentation
- Unit Testing
- Integration Testing
- System Testing
- Site Acceptance Testing (SAT)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Requirements Traceability
- Enterprise Systems including CRM, ERP, EAM, and SFA
- Laboratory Systems including
- Laboratory Operations (R&D, QA/QC)
- Quality Systems including CAPA, Data Management, Clinical Trial Applications, and SharePoint
- Pharmacovigilance and Medical Information Systems