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EN ISO/IEC 17 025
Validation of methods (titration, UV/VIS, gravimetry, HPLC, GC)
Validation is the confirmation by examination and the provision of effective evidence that the particular requirements for a specific intended use are fulfilled.
The laboratory shall validate non-standardized methods, laboratory designed/developed methods, standardized methods used outside their intended range and amplifications of standardized methods to confirm that the methods are fit for the intended use.
The range and accuracy of the values obtained from validated methods (e.g. uncertainty of the results, detection limit, selectivity of the method, linearity, limit of repeatability and or reproducibility, robustness against external influences and/or cross sensitivity against reference from the matrix of the sample/test object) as assessed for the intended use shall be relevant to the clients’ needs.
Validation includes the specification of the requirements, determination of the characteristics of the methods, the comparison of the requirements with the values of the characteristics of the method, and a statement on the validity.
The techniques used for the determination of the characteristics of a method should be one of, or a combination of, the following: calibration using reference standards or reference materials, comparison of results achieved with other methods, inter-laboratory comparisons, systematic assessment of the result, assessment of the uncertainty of the results based on scientific understanding of the theoretical principles of the method, and practical experience.
As method development proceeds, regular review is required to verify that the needs of the client are still being fulfilled. Changing requirements requiring modifications to the development plan should be approved and authorized.
Validation is always a balance between costs, risks and technical possibilities.
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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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