SoftMax® Pro GxP Software is designed for regulated GMP and GLP laboratories that require secure, compliant data management workflows. Built to support FDA 21 CFR Part 11 and EudraLex Annex 11 requirements, the software combines advanced microplate reader control with integrated compliance tools, audit trails, electronic signatures, and validation support.
Every step is optimized to maintain data integrity, streamline reporting, and simplify compliance processes. With secure role-based access, automated documentation workflows, and integration capabilities for laboratory data systems, SoftMax Pro GxP Software provides end-to-end chain of custody for regulated environments.
Video Credit: Molecular Devices UK Ltd
Ensure compliance with confidence
SoftMax Pro GxP Software helps laboratories meet FDA 21 CFR Part 11 and EU GMP Annex 11 requirements through secure electronic records, audit trails, electronic signatures, and validation tools that support compliant workflows.
Maintain data integrity
A paperless document management workflow tracks a document's status throughout development, review, approval, and use. Controlled eSignatures and structured release processes help preserve data integrity across projects.
Streamline regulated workflows
Role-based permissions, project management capabilities, and automated save functions reduce manual effort while ensuring users follow approved processes and maintain compliance requirements.
Features
Complete audit trail
Track and record all document and data changes with date and time stamps, user information, signature details, and read results to provide complete traceability.
Simplified user administration
Manage users via Windows Active Directory or GxP Admin software, simplifying control of password policies, user access, and security settings.
Automatic data protection
New documents must be saved before modification, while automatic saving before and after reads helps prevent data loss and improves record reliability.
Structured project management
Assign users to projects with defined roles and permissions to maintain controlled workflows. Predefined roles help laboratories deploy compliant processes quickly and consistently.
Secure electronic signatures
Support compliant document review and approval processes with controlled electronic signatures and standardized signing workflows that reinforce data integrity.
Flexible data export
Automatically export data in multiple formats, including XML, to support integration with LIMS and SDMS platforms while maintaining regulated reporting workflows.