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fDesc[0] = "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. <br /> The software helps to resolve the following issues:<br /> Validation of analytical (microbiological) methods (ICH, USP, Eurachem standards and interpretation guides)<br /> Interlaboratory Comparison (ISO 5725)<br /> Control Charts (ISO 8252)<br /> Calibration models (ISO 8466-1,-2)<br /> Uncertainties of analytical results (Eurachem/CITAC Guide)<br /> Electronic Records and Signatures (21 CFR Part 11)<br /> The software is compliance-ready and offers: <br /> 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)<br /> Conformity to Electronic Records and Electronic Signatures Final Rule (21 CFR Part 11)<br /> Documentation: Functional specifications for computer systems, IQ - Installation Qualification, OQ - Operational Qualification, as the basis for ongoing qualification process.";

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