MVA 2.1 - A Supporting Tool in Method Validation

The Software "Method Validation in Analytics - MVA" has been designed for the calculation of validation data based primarily on the guidelines of the International Conference on the Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH).

The MVA-Software enables the user to check the analytical data with statistical tests and parameters and to document and verify the suitability of the method.

The software allows for individual selection of the number of analyses, determinations and series, as well as the calculations, tests and parameters the acceptance criteria and the graphical presentations.

This provides the flexibility to select those tests and parameters relevant for the given analytical procedure in order to evaluate its real performance.

Overview:

• Evaluation of validation data
• Calculation of validation data
  • Linearity, accuracy, precision, detection and quantitation limit
• Statements concerning specificity, work space and robustness can be implemented
• Monitoring of analytical data
• Examination after the Summit-D methodology
• Analytical validation based on the ICH-guidelines
• With interactive help function and detailed manual

Product Description:

• Clear and easy setup
• Operator convenience
• Calculation of all parameters required by regulatory authorities is possible
• Calculation of additional parameters and several statistical procedures
• Flexible template assembly
• Standardization is possible due to reutilization or adaption of templates
• Detailed help function with explanations and background information for validations

Terms of Delivery:

• CD with files for installation and qualification, description of the program in ReadMe- and PowerPoint-Files
• Validation certificate for the MVA 2.1-Software

Interested in ordering a test version or a license?

We can offer a free MVA CD-ROM for a six-week-trial.