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

User Requirement Specification EffiValidation 3.0

The User Requirement Specification (URS) EffiValidation 3.0 has been developed by EffiChem to help customers to specify their requireements related to the system architecture, functionality, security and compliance with the ISO 17025 and GMP regulations.

This document covers the following areas:

  • IT system requirements
  • Archival, backup and recovery
  • Access control and account privileges
  • Audit trail
  • System configuration
  • Method validation
  • Uncertainties estimation
  • Control charts
  • Calibration
  • Inter-laboratory comparison
  • Electronic laboratory loggbooks
  • Software validation
  • 21 CFR Part 11: Electronic records and signatures

The standard URS can be customized on request to better cover the specific user requirements and expectations of the customer. Please use the form below to specify your requirements:

* Required items