The software EffiValidation 3.0 is designed to meet requirements of Testing and Calibration laboratories accredited according to International Standard EN ISO/IEC 17025:2001 and requirements of Quality Control laboratories operating under the GxP compliance requirements.
The software helps to resolve the following issues:
Validation of analytical (microbiological) methods (ICH, USP, Eurachem standards and interpretation guides)
Interlaboratory Comparison (ISO 5725)
Control Charts (ISO 8252)
Calibration models (ISO 8466-1,-2)
Uncertainties of analytical results (Eurachem/CITAC Guide)
Electronic Records and Signatures (21 CFR Part 11)
The software is compliance-ready and offers:
High level of software validation and quality as it was designed and developed under a Development Life Cycle process (General Principles of Software Validation, Final Guidance and GAMP 4: Guide to Validation of Automated Systems)
Conformity to Electronic Records and Electronic Signatures Final Rule (21 CFR Part 11)
Documentation: Functional specifications for computer systems, IQ - Installation Qualification, OQ - Operational Qualification, as the basis for ongoing qualification process.