Computer System Validation

Computer systems validation, testing and compliance services

Computer systems validation, testing and compliance services

If you’re seeking computer system validation experts, look no further. Xybion has demonstrated expertise validating computer programs for all types of regulated businesses in 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 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 Validation Specialists have successfully completed over 1,000 validation projects. Are you ready to be next?

Our Systems and Equipment Validation Processes Encompass The Entire Gamut of Business Operating Systems.

Our Process

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 Initiation and Planning

  • Project Management
  • Software Development Life Cycle
  • Gap Assessments
  • Risk Assessments
  • Validation Master Planning (VMP)

System Requirements and Design

  • User Requirements Specifications (URS)
  • Functional Specifications (FS)
  • Design Specifications (DS)
  • Design Review

System Operation

  • Data Archiving
  • Continuity Planning
  • Change and Configuration Management
  • Incident and Problem Management
  • Periodic System Reviews
  • Best Practices

Supplier & Vendor Audits System Development and Verification

  • 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

System Type Expertise

  • 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

Ready to learn more? Book a free demo.