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Computer System Validation Services

stelexlogosmall Stelex, formerly a GE Company and acquired by Xybion, is one of the most trusted brands in computer systems validation services, education and consulting. Stelex team has been providing services to some of the worlds leading brands since 1977.

COMPUTER SYSTEMS VALIDATION, TESTING AND COMPLIANCE SERVICES

Our Compliance & Validation Services

Your trusted partner for Computer System Validation and Software Testing Services. Stelex Compliance Services provides superior service and expertise required to meet all of your Computer System Validation and Software Testing needs. As a leading global enterprise solutions and services organization for over 30 years, Stelex proves the foundation of our business is found in our dedication to established quality processes, personalized support, and the success of your projects.

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In the past ten years, our firm has successfully completed over 1,000 projects in several highly regulated industries including Life Sciences, Energy, Transportation, and Finance. Stelex can help you define and complete your validation projects on time and within budget through our services and enterprise solutions. With global experience including projects in the USA, Canada, EMEA, and Asia-Pac, Stelex leverages its extensive experience to cover all of your GxP and other compliance standard needs.

OUR PROCESS

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BENEFITS WE DELIVER:

Reduce Long Term Costs – We have the capability to deliver projects from our HQ in Bensalem, PA or off-shore in our Global Delivery Center in Chennai, India.

Experience Efficient Business Processes – As project scope increases/decreases, Stelex turns around quickly with a smooth scaling up or scaling down response.

Collaborate with Dedicated, Highly Experienced Consultants – Our employees are renowned for their domain experience, practical understanding and implementation ofregulatory requirements. Stelex consultants have an average of 10+ years of expertise in Validation. Stelex Compliance Services Key FactsValidation and qualification services have been core competencies of Stelex since the company’s inception in 1977. Your Validation specialists have completed over 500 validation projects.

Stelex consultants have extensive global experience – Stelex features on shore and off-shore capability with its Global Compliance Center, located in Chennai, India. Our clients include Merck, Novartis, and many more.

Stelex consultants have extensive experience with FDA regulations and in the mitigation of risk for companies of all sizes. All projects utilize industry best practices in methodology and deliverables.

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
  • Pharmacovigiliance and Medical Information Systems