Specification for electronic signature, audit trail, and data integrity features.
Software development life cycle analysis.
Integration testing documentation.
Assistance in FDA 21 CFR part 11 compliance.
The software validation package is designed to help you achieve GLP and GMP compliance by allowing you to validate
the built-in calculations in SoftMax Pro software's menus and Group table column formulas, as well as your own custom
formulas. The validation package includes data sets used to validate SoftMax Pro's calculations, instructions for
creating custom data sets to validate custom calculations, ASCII text files, Microsoft Excel® spreadsheets to
check the results of SoftMax Pro calculations, some guidelines for IQ/OQ/PQ validation, and a manual containing
extensive documentation. Validation packages are available for both Windows® 2000/NT/XP Pro and Mac OS®
operating systems. Validation packages for previous versions of SoftMax Pro are also available.
CLICK HERE for the validation package datasheet (registration required).
