Validation of Computerized Systems and Equipment ensures that a computerized system or equipment is appropriate for its intended use. A typical validation life cycle consists of the following phases:

• Installation Qualification (IQ) demonstrates
  • That equipment is installed according to pre-determined specifications.
  • Correct installation and configuration of software and hardware as documented in the Design and/or Configuration Specifications (DS/CS).
• Operational Qualification (OQ) demonstrates
  • That equipment operates according within specified operating ranges as defined in pre-approved specifications.
  • Correct operation of software functionality throughout operating ranges as defined in the Functional Specification (FS).
• Performance Qualifications (PQ) demonstrates
  • That equipment performs as intended according to pre-approved specifications.
  • That software performs as intended use as defined in the User Requirements Specification (URS).

The diagram shown below depicts the validation life cycle for equipment and computerized system.