"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:

• Analytical validation based on the ICH-guidelines
• 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
• Languages:
  - German, English, French, Spanish, Japanese

• detailed online help function
• System requirements:
  - Windows 98, NT, 2000, XP; MS Office ≥ 2000

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.

Further Information
NOVIA Chromatographie- und Messverfahren GmbH
Frankfurt am Main, Germany

Contact

Overview MVA 2.1 (20KB)   Licensing Terms Software Overview MVA 2.1 (1,3 MB) Modem (56 kbps): 3-5 minutes ISDN (64kbps): 2-4 minutes