Validation

Specifications and Documentation
Our engineers and specialists develop comprehensive design and validation documentation that fully specify and prepare the system for testing.

  • Validation Master Plans
  • User / Functional Requirement Specifications
  • Software / Hardware Design Specifications
  • Traceability
  • Drawings and Schematics
  • Code Standards
  • Change Control
  • Equipment Upgrade and Replacement Strategies
  • SOP Development
  • Training Materials
  • IT System Policies

Commissioning
E2i commissioning services provide for seamless transition of systems from development through validation.

  • Commissioning Protocols and Execution
  • Factory / Site Acceptance Testing
  • Simulation, Test Stand
  • Dry Run of Validation Protocols
  • Cycle Development
  • Drawing Verifications
  • I/O Verifications
  • Source Code Reviews
  • Project Management and Coordination

Validation
Our validation engineers and specialists develop and execute testing protocols to assure compliance of the system or facility.

  • Facility / Utility Validation
  • Computer System Validation
  • Process / Cleaning Validation
  • Installation / Operational / Performance Qualification
  • Design Review / Qualifications
  • Equipment Qualification / Validation
  • 21 CFR Part 11 Testing and Analysis

Software and Code Compliance
E2i’s experienced software validation engineers execute protocols and code reviews to assure the highest quality scripts and programs.

  • User Acceptance Testing
  • Unit / Functional / Integration Testing
  • Source Code Review
  • User Manual Development
  • Training Material Development
  • 21 CFR Part 11 Compliance