EffiValidation 3.0 is a compliance-ready ISO 17025 and GxP laboratory software.

Software Validation

EffiValidation software was validated throughout the entire software life cycle, including:

  • Quality Planning
  • System Requirements
  • Software Requirements Specification
  • Software Designs Specification
  • Construction or Coding (implementation of requirements to the source code)
  • Testing (integration and testing to confirm compliance with the specification)

Installation/o­perational qualification (IQ/OQ) has to be performed after the installation on the given computer to verify:

  • Installation: testing of the installed version/files to check the size, date of origin, and file description;
  • Operation: to check the correct function of the software and the computer systems before/during routine use.
Software validation - Operational qualification.jpg