Business Impact

Business Impact

Computer system validation is more than a compliance requirement.

Validation is a unique opportunity for a business to examine their computer systems to maximize effectiveness and enhance quality.

Shodann ensures that your validation project clearly documents why your clients should share the high degree of confidence you hold in your company and your systems, while scaling the project to your organizational validation requirements and budget.

AREA of expertise

Area of Expertise

  • Computer System Validation
    • Metrology Lab CSV
    • Labelling system to meet regulatory UDI requirements
    • Quality Lab CSV
    • Building Management System
    • Misc.
  • Data Integration Validation
CSV experts

Computer System Validation Experts

  • Certified IT Professionals with regulatory knowledge including:
    • CSV Engineers
    • Software Architects
    • Senior Software Developers
    • Software Testers with automated regression experience.
  • Certified Lean Six Sigma Black Belt Professional with over 15 years of extensive statistical knowledge used in the Medical Device Industry
  • CTO with over 12 years experience in the Clinical Trials Industry, 2 years experience in the Medical Device Industry and over 16 years in Software development.
Experience

Our Offer

  • Experience assisting clients in the Medical Device and Clinical Trials Industry.
  • In-house Software Development team to correct any deployment problems.
  • We can establish the development process from end-to-end to meet regulatory requirements.
  • We can provide validation resources to meet your SDLC requirements.