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Repeatability - Level by level !
Your laboratory can have the repeatability determined in just a few seconds.
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Method Validation software
21 CFR Part 11 compliance ready; IQ/OQ ensured
Method Validation and Uncertainty software EffiValidation 3.0
is designed to support accredited ISO 17025 testing and calibration laboratories and quality control GMP laboratories.
For all analytical methods, e.g. HPLC, GC, titration, etc..., repeatability, accuracy, linearity, LOD are covered and can be validated with this software (Read more).
Other compliance issues such as uncertainties, control charts, calibration and method comparison are also included.
Easy use is achieved by means of extensive instructions in each window where caluations are carried out.
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In addition, electronic record books for samples, equipment, reference standards and chemicals are avaliable as well.
EffiChem Method Validation software is 21 CFR Part 11 compliance ready.
Practical analytical method validation examples are part of demoversion and book of reference examples (see Download).
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ISO 17025 accredited laboratories - method validation
The ISO/IEC 17025 standard specifies the general requirements a laboratory has to met if it is to be recognized as competent to carry out tests and/or calibrations, including sampling.
Read more
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GMP quality control (GxP) laboratories - method validation
Method validation within the GMP environment ensures that the method (e.g. HPLC, GC residual solvents, titration, etc.) is suitable for the intended use. The validation shall be done in accordance with ICH Q2 (R1) and/or USP chapter ‹1225›.
Read more
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Why our method validation software ?
- Comprehensive, easy to understand, simple to use laboratory tool for a competitive price
- Compliance with the ISO 17025 and GxP guidelines guaranteed
- All-in-one product (Method Validation, Uncertainty, Control chart, etc..)
- Extensive documentation, software Help, DEMO project and Book of Reference Examples
- How-to for each method describes a practical example and corresponding results, covering the data evaluation including outliers and normality testing, summary tables and related charts.
- More than 420 users over the world
- 51 statistical algorithms and 9 electronic record books
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The main features and improvements
- Software validation requirements met
- Emphasis on statistical methods to validate testing/calibration methods, estimate uncertainties, develop control charts and calibration models, and to enable inter-laboratory comparison
- Database of samples, equipment calibrations, standards, chemicals, documents and complaints included
- Automatic evaluation of data and hypothesis testing
- Automated generation of test reports in numerical and graphical form
- Easy-to-use, intuitive handling based on Microsoft standards, feasible for all laboratory personnel
- And much more...
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