Computer System Validation, Testing and Compliance Services

Xybion Compliance Services provides superior service and expertise required to meet all of your Computer System Validation and Software Testing needs. We have successfully completed over 1,000 projects in several highly-regulated industries including Life Sciences, Energy, Transportation, and Finance. We can help you define and complete your validation projects on time and within budget through our services and enterprise solutions.Computer system validation

With global experience including projects in the USA, Canada, EMEA, and Asia-Pac, we leverage our extensive experience to cover all of your GxP and other compliance standard needs. We have the capability to deliver projects from our HQ in New Jersey or off-shore in our Global Delivery Center in Chennai, India. Our employees are renowned for their domain experience, practical understanding, and implementation of regulatory requirements. Our consultants have an average of 10+ years of expertise in Validation.

Xybion Compliance Services Key Facts Validation and qualification services have been core competencies of Xybion since the company’s acquisition of Stelex in 2011. Our Validation specialists have completed over 1000 validation projects.

Our Process:

Computer System Validation

Our Program:

Our support begins with assigning a group of highly-qualified and experienced consultants to your project. We staff projects based on required expertise and scope, providing the most efficient and cost-effective Computer System Validation services possible, including: 

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 

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 Operation: 

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

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