laboratory software for validation of analytical methods according ISO 17025 for accredited laboratories and GMP quality control regulations
Method validation (validation of analytical methods)
Method validation consists of documenting the quality of an analytical procedure, by establishing adequate requirements for performance criteria, such as accuracy, Precision, limit of detection, etc. and by measuring the values of these criteria. The goal of method validation is to prove that the method is suitable for the intended purpose. When this is achieved, the validation of analytical method is completed.
Rules of method validation to be kept in mind
Validate the whole method (incl. all preparatory steps)
Validate over the whole range of concentrations
Validate over the whole range of matrices
Depending on the purpose of the analytical method, several types of validation of analytical method can be distinguished, such as Exploratory validation, Full validation, etc. All these types are covered by the software.
Method uncertainty
Any measurement includes a certain level of uncertainty which is caused by the instrument selected and personnel using it.
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...
