Validation

As a proven engineering services provider with world class capabilities and a strong record of success in automation engineering and information technology, E-Technologies Group offers a full scope of validation services to clients in FDA-regulated industries.

Our validation team experts have a diverse portfolio in pharmaceutical, biotech, and medical device environments and experience ranging from process equipment and utilities to facilities, IT, infrastructure, and more. E-Technologies Group validation engineers have a track record of success at cGMP and FDA-regulated facilities throughout North America and beyond.

Our Validation Team will partner with your quality and engineering resources to provide validation deliverables per your requirements. We perform on your behalf from project inception to completion in both a project management role and a project delivery role, as needed.

Examples of Systems Serviced

Some typical examples of systems serviced by E-Technologies Group Validation Services include automated and manual equipment, control systems, temperature mapping of critical and non-critical areas, utilities, facilities, differential pressure, particulate recovery testing for various environmental classifications, fluid bed processors, tablet presses, granulators, blenders, packaging and labeling systems, vision technology, manual and automated device assembly, fillers, tanks, homogenizers, HVAC systems, purified water, IT software applications, infrastructure, and more.

Services We Offer

Lifecycle Documentation:

  • Master Planning
  • Risk Assessments
  • Requirements Traceability Matrix
  • User Requirements Specifications
  • Functional Requirements Specification
  • Software Design Specification
  • Design Review/Acceptance

Qualification Documentation and Execution:

  • Qualification/Test Plans
  • Installation Qualification
  • Operational Qualification
  • Performance Qualification
  • Incident Reporting/Resolution
  • Qualification Summary Reports

Integrated Commissioning & Qualification:

  • Utilities/Facilities/Equipment
  • Comissioning Plans
  • Engineering Turnover Package (ETOP)
  • Construction Turnover Package (CTOP)
  • Component Criticality
  • Code Review
  • Receipt and Installation Verification
  • Factory Acceptance Testing (FAT)
  • Site Acceptance Testing (SAT)
  • Functional Testing
  • Integration Testing
  • Commissioning Summary

Additional Validation Services:

  • System Validation Audits
  • Remediation/Retrospective
  • 21 CFR Part 11 Assessments
  • Vendor Audits - software and equipment
  • Change Controls
  • SOPs
  • Operating Instructions
  • User Manuals