Validation of analysis methods
Validate to use reliable and robust methods
All laboratories do not perform the same analyzes and do not have the same obligations to respect. However, the validation of analytical methods is one of the basic elements to be mastered in order to be able to claim that the analyzes carried out produce reliable and credible results which will be recognized by the representatives of the regulatory authority , the firms of audit and customers.
In addition to this, you will need to know more about it.
Just because you are using an official method does not mean that you can consider it validated under your conditions, which are your facilities , equipment or analysts . This is precisely what the validation exercise consists of: demonstrating that you can perform the analyzes with the same rigor , the same precision , the same level of control in your specific conditions.
In addition to this, you need to know more about it.
When the results of the analyzes carried out are used internally only and are not subject to be officially transmitted or will not be used to resolve non-conformities , etc .; the validation exercise can ultimately be simplified . On the other hand, this remains on a case-by-case basis .
In addition to this, you need to know more about it.
In all other cases ; it is important to carry out the most complete validation possible in order to benefit from reliable and robust methods.
How to validate a physico-chemical analysis method?
There are several guides to help you make the validation of analytical methods. There are even videos on YouTube and presentations of all kinds online. It is a question here of clearly delimiting what you have to do and not to get carried away. You can, without problems, make the validation of an analytical method without being certified ISO 17025.
In addition to this, you need to know more about it.
The essential conditions are:
In addition to this, you need to know more about it.
To have implemented a program of Good Laboratory Practices
To have qualified staff
To have the required equipment , machines and devices
To have chosen the method (s) to validate and to have tried / practiced it several times
In addition to this, you need to know more about it.
The most important basic parameters to validate to start operating are:
In addition to this, you need to know more about it.
Determination of the detection limit
Determining limits of quantification
Sensitivity
Repeatability
Trueness or precision
In addition to this, you need to know more about it.
The validation will then be done by carrying out series of analyzes with the chosen method and by making the calculations allowing to obtain the validation parameters under your conditions , The results of these calculations will be compared to the levels of performance expected for this method before the declared officially validated .
In addition to this, you need to know more about it.
And once the method is validated ...
Once the method is validated you will need to institute quality controls to ensure that you stay the course and are still operating under the conditions that allowed you to validate your method.
In addition to this, you need to know more about it.
We are able to help you validate your analysis methods so that you produce reliable , credible results that will be recognized . This will help to make your lab smoothly and increase the level of confidence you have in your methods and the results of your analysis. This will facilitate discussions about the test results and the methods used by your laboratory when speaking with representatives of the regulatory authority , audit firms and customers . It will help you meet regulatory, normative and customer compliance requirements (including those stipulated in GFSI standards) more easily and with confidence .
In addition to this, you need to know more about it.