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Computer System Validation

Computer systems validation, testing and compliance 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 Validation Specialists have successfully completed over 1,000 validation projects. Are you ready to be next?

Book a Consultation

Book a free consultation with us now to experience a tailored CSV solution that specifically addresses your current business needs.

Reduce Compliance Risk

Implement an all-in-one digital cloud platform to be always ready to meet compliance needs.

Increase Efficiency​

Replace standalone applications and paper trails with fully customized digital solutions.

Reduce Cost by 30%

Compliance Embedded, Quality Engrained, Data Integrity Assured

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

Review & Approve

Closeout & Summary Report

Document

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