SoftMax Pro GxP Software

Description

SoftMax Pro GxP Software from Molecular Devices, LLC is a data acquisition and analysis platform designed for microplate readers, with features supporting regulatory compliance. It is developed to meet requirements such as FDA 21 CFR Part 11, focusing on data integrity and security. The software includes user management that can integrate with Windows Active Directory or be administered internally, allowing control over password policies and user roles. Predefined roles—Scientist, Lab Manager, and Lab Technician—facilitate a document release workflow. Functionality includes an auto-save feature that requires new documents to be saved before modification and saves data automatically before and after a plate read. An electronic signing process restricts users to one pre- and post-release statement per document. The software supports project-based team structures, where users can have different roles across projects but not within the same project. Data can be exported automatically to external locations in various formats, including XML, for integration with LIMS or SDMS. It is applicable to a wide range of assay types, including cell viability, ELISA, enzyme activity, DNA/RNA quantitation, reporter gene assays, HTRF, fluorescent protein detection, and kinase assays. The vendor offers installation qualification and operational qualification services to support validation for regulated environments.