FEASIBILITY STUDY
The support provided can concern both the sample preparation phase and the instrumental phase, and if it is a non-standard method we are able to guide you in the complete validation process of the method itself, as required by certification bodies such as Accredia. We remind you that, as established by the ISO / IEC 17025 standard, the laboratory must validate non-standard methods, methods developed / designed by the laboratory, standard methods used outside its intended field of application, as well as extensions and modifications of methods. to confirm that the methods are suitable for the intended use.
Validation must be extended to meet the needs of a given application or field of application. The laboratory must record the results obtained, the procedures used for validation, as well as a statement about the suitability of the method for the intended use.
In the case of non-regulated methods we can therefore support you through the following steps:
- Bibliographic searches
- Optimization of the sample preparation phase with evaluation of ion suppression and matrix effect
- Development of an instrumental method
- Evaluation of all validation parameters required by current guidelines, namely: measuring range, analytical specificity and selectivity, limits of detection and quantization, linearity, recovery, repeatability, robustness, uncertainty
- Custom analytical reports
- Periodic verification methods of validation
- Possible interfacing with LIMS systems
The feasibility study is initially developed and optimized in our demo laboratories and subsequently implemented at the customer's final laboratory.
