The new analytical online method verification service
A laboratory using a specific method should have provided evidence that the method has been adequately validated. This applies both to internally developed methods and to standard methods developed, for example, by organizations such as the ISO, CLSI or the USP.
There are usually a number of questions about the validation of standard methods:
- Should these methods be first validated in the user’s laboratory and should the re-
validation of the methods cover all experiments performed during initial validation?
- What documentation should be available for standard methods or developed
The validation of standardized or jointly tested methods should not be taken for granted, regardless of how flawless the method is. The laboratory should be satisfied that the validation level of a particular method is appropriate for the required purpose and that the laboratory itself is able to meet all specified performance data.
Like the validation of self-developed methods, the evaluation and verification of standard methods should follow a documented process, which is usually the validation plan. The results should be documented in the validation protocol. Both documents are the main source for the validation report.
Up to now it is not real clear how much of these verification methods are really used and needed, but we put all of them in our project milestone.
The tool should generate its benefits in combination with TIQCon, so instruments, analytes, controls , targets, peergroup results and also measurements can/should be overtaken.
Also our TIQCon data capture solutions like TIQ-Box and GlobalQCconnect program should be used to automatically capture needed results from the analyzer.
The main goal is to minimize all manual operations.
This new service should help and guide to verify, time cyclically, already validated standard methods in laboratory analysis.