The Software Validation Package for SoftMax® Pro Data Acquisition & Analysis Software and SoftMax® Pro GxP Compliance Software provides essential information and sample test scripts to assist in the validation process, letting you spend less time drafting validation plans and more time on the science.
Software validation is an important requirement for GLP, GMP, and other regulated environments to establish confidence in the acquired and analyzed data. Documenting the system capabilities and verifying the accuracy of calculations can become an extensive, time-intensive process. Molecular Devices was the first to support features for 21 CFR Part 11 compliance for microplate readers, and one of the key products in that history of supporting customers in regulated environments is the Software Validation Package.
Molecular Devices offers two software validation packages
- Validation package for SoftMax® Pro GxP version 6.4
- Validation package for SoftMax® Pro GxP version 5.4
Validation Package Features
- Detailed software specifications for SoftMax Pro and SoftMax Pro GxP Software with respect to FDA 21 CFR Part 11 implementation and Molecular Devices software development and quality processes
- Included example data sets to save time verifying built-in calculations in SoftMax Pro and SoftMax Pro GxP Software
- Microsoft Excel spreadsheets for side-by-side comparisons of calculations that can be further customized for validating user-defined formulas
- Graph Pad Prism data files for validation of curve fittings offered and Parallel Line Analysis (PLA)
- Answers to Frequently Asked Questions (FAQ) collected from customers working in regulatory environments to facilitate validation process
The Software Validation Package is intended for use with SoftMax® Pro and SoftMax® Pro GxP Software on Molecular Devices Microplate Readers.
- SoftMax Pro Validation Packages
- SoftMax Pro and SoftMax Pro GxP Software, Version 6.X
- SoftMax Pro and softMax Pro GxP Software, Version 5.X
|Validation package for SoftMax Pro GxP version 5.4||Contents: manual and on CD: detailed software specifications for SoftMax Pro® and SoftMax Pro® GxP Software, sample data sets for testing basic calculations, pre-formatted spreadsheets for testing custom calculations, and a wealth of answers to frequently asked questions around topics like 21 CFR Part 11 implementation and Molecular Devices software development and quality procedures||SMP54-VAL-PAK|
|Validation package for SoftMax Pro GxP version 6.4||Contents: electronic manual on a CD with detailed software specifications for SoftMax Pro and SoftMax Pro GxP Software; a wealth of answers to frequently asked questions around topics like 21 CFR Part 11 implementation and Molecular Devices software development and quality procedures; sample data sets for validation of important curve fits, including parallel line analysis||SMP64-VAL-PAK|
|SpectraTest ABS Absorbance Validation Plate||0200-6117|
|SpectraTest FL1 Fluorescence Validation Plate||0200-5060|
|SpectraTest LM1 Luminescence Validation Plate||0200-6186|
|Cuvette Validation Set||0200-2420|
|Multi-Mode Validation Plate||For FilterMax F3 or F5/SpectraMax® Paradigm® Microplate Readers||0200-7200|