Software for analytical method validation
VAM�s new method validation software mVal, is a powerful and flexible method validation management package, providing all the statistical tools necessary for fast and efficient validation. Designed for outstanding flexibility, mVal's validation design module provides a unique 'building block' approach to validation suite planning for complete tailoring to individual requirements; experiment types, performance characteristics, numbers of replicates, outlier testing - even the terminology - can be adapted to suit the customer or regulator. mVal also allows import and export of protocol definitions through the industry-standard XML format, allowing rapid transfer between users or user and customer. It is simple to apply; at the push of a button, analysts can select predefined protocols for each customer or regulatory requirement.
Features:
- Protocol editor: allows the analyst to set up their own implementations of regulatory validation procedures or set up validation for different customer requirements.
- Qualification-led
protocols allow specification of required performance and allow for automatic qualification or manual pass/fail.
- Protocol import/export
: protocol definitions for established regulations can be imported, and in-house or customer-specific protocols can be exported using
- industry-standard XML format.
- Wide range of experiment designs, from simple replication to formal ruggedness tests.
- Cut and paste data entry from spreadsheets
- Support for printed worksheets to aid data collection and work scheduling.
- All necessary statistical procedures built in.
- Graphical data
review and inspection allowing full cut and paste for reporting.
- Flexible reporting
covers individual experiments or complete summary listing.
- Supplied with a basic set of example protocols for quick basic studies and exploration.
- User-definable terminology
for method performance characteristics - measure accuracy in terms of 'recovery' or 'bias' to suit the client.
- Growing web-based library of current method validation protocols - keeps up with current regulations and speeds local protocol development.
mVal makes good use of data as well, with some experiments delivering results for multiple performance characteristics, thus reducing time and cost.
System requirements
- Windows 2000, 500MHz
- Disk space: 12MB
- RAM: 128MB
- Colour monitor 1024 x 768 (will run on 800 x 600)
- CD-ROM drive
Costs
Single user licence: �150 + VAT
Two-user licence: �225 +VAT
Licences for three or more users: �225 (two-user rate) + �50 for each additional user + VAT
To purchase this product, download the order form (PDF) and send it to the VAM helpdesk with your payment.
On-line ordering is no longer available from the VAM website.