Software Validation Tools
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.
For GLP, GMP, and other regulated environments, software validation is an important requirement for establishing 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. This offered package is more comprehensive than any other microplate reader software validation support tools.
Currently we offer two software validation packages:
- Validation package for SoftMax Pro GxP version 5.4
- Validation package for SoftMax Pro GxP version 6.2
Validation package for SoftMax Pro GxP version 5.4 contains a 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.
Validation package for SoftMax Pro GxP version 6.2 contains an 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; Detailed IQ document and worksheets; OQ document and worksheets with sample data sets and instructions to validate basic and custom calculations; sample data sets for validation of important curve fits, including parallel line analysis.Together, this comprehensive documentation streamlines and simplifies the validation process.
- 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.
- Detailed IQ procedure
- Detailed OQ procedures that can form the basis of PQ performed by customers
- 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
Easy Validation of Luminescence Detection Mode with the new SpectraTest LM1 Validation Plate. Learn more.