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Method Validation Software - EffiValidation
Laboratory software for the validation of analytical methods according to 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.
In the software EffiValidation, there are three ways of estimating uncertainty:
- From Precision data
- From Control Charts
- Prom Partial Uncertainties
Example of a measurement uncertainty estimation based on the partial uncertainties as presented in the Eurachem guide, Examples A3, is shown below:
The results are presented in the numerical and graphical form. The length of the bar in the bar chart shows the importance of the partial uncertainty in the overall combined uncertainty.
Calibration
Calibration is a way to construct the calibration function (model) based on measured values (yi) recorded for a given set of standards having a known standard concentrations (xi).
The software EffiValidation enables to construct two types of models:
- Linear model
- Quadratic model
Example of a linear calibration model constructed for the data from ISO 8466-2:1999(E), example on page 7, is presented below:
For the entered data, the linear calibration is calculated and displayed. Concentration of new samples (for which the concentration is unknown) is determined from the measured values and the calibration model.
Control charts
The control charts or statistical process control charts are used to monitor the performance of the analytical methods over the time, answering the question whether or not the method still yields the same result for some reference sample/standard. "The same" is seen as having the same mean value with the same precision, which means a bias free method which is still sufficiently precise.
In line with the ISO 8258 standard EffiValidation 3.0 enables to construct control charts for:
- Individual Measurements - Characteristics Determined
- Individual Measurements - Characteristics not Determined
- Repeated Measurements - Characteristics Determined
- Repeated Measurements - Characteristics not Determined
Example of a control chart constructed for individual measurements where characteristics are determined, for the data from ISO 8258:1994, example on page 21 and 22, is presented below:
The + and - limits at 1, 2 and 3 s (standard deviation) level are constructed in the control chart to monitor the method performance and trends.
Inter-laboratory comparison
Inter-laboratory studies/comparisons are performed with the aim to evaluate how similar are results obtained by different laboratories using the same method. The statistical procedures considered in software EffiValidation are based on the ISO 5725 standard, namely:
- Mandel's Statistics h
- Mandel's Statistics k
- Collaborative Studies - evaluation of Repeatability and Reproducibility
Example of the Mandel's Statistics h is presented below:
Electronic record books
To extend the software features the following electronic record books are included in software EffiValidation:
- Book of Samples (Simple and Advanced)
- Book of Specifications
- Book of Equipment (Simple and Advanced)
- Book of Documents
- Book of Deviations
- Book of Contacts
- Book Reference Standards
- Book of Chemicals
- Book of Volumetric Solutions
Example is presented below:
Software validation
Software EffiValidation was validated throughout the entire software life cycle, including:
- Quality Planning
- System Requirements
- Software Requirements Specification
- Software Designs Specification
- Construction or Coding (implementation of requirements to the source code)
- Testing (integration and testing to confirm compliance with the specification)
Installation/operational qualification (IQ/OQ) has to be performed after the installation on the given computer to verify:
- Installation: testing of the installed version/files to check the size, date of origin and file description.
- Operation: to check the correct function of the software and the computer systems before/during routine use
21 CFR Part 11
21 CFR Part 11 is a US Federal Standard specifying requirements on electronic records and signatures. In the software EffiValidation the following tools are implemented to cover these requirements:
- Access controls
- Automatically generated Global Audit Trials and History of electronic records
- Unique secure electronic signatures
- Ability to disclose deleted records, i.e. the bin
Global Audit Trial and History consistently records the User Name, Computer Name, Date and Time of entering and editing data and performing software operations. All data entered and saved in the software are stored in a database; data handling is recorded in History, without any option of changing, re-writing or concealing previous information. Also, data deleted using the function 'Delete' are kept in a re-cycle Bin, from which they can be displayed or restored.
The History window can be, through the whole software (in the List of Methods window, Data Table window, electronic Record Books, etc.), opened by clicking the History button. The appearance of the opened History window is the same as at the given Date and Time.
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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
- Automated data evaluation 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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