SoftMax® Pro GxP is a software solution designed to assist good manufacturing practices (GMP) and good laboratory practices (GLP) laboratories in implementing secure, compliant data management workflows.
The software integrates advanced microplate reader control with built-in compliance features, validation support, electronic signatures, and audit trails, and meets EudraLex Annex 11 and FDA 21 CFR Part 11 requirements.
Each step has been optimized to streamline reporting and maintain data integrity, thereby simplifying the compliance processes. SoftMax® Pro GxP offers an end-to-end chain of custody for regulated environments by automating documentation workflows, providing secure role-based access, and allowing seamless integration with laboratory data systems.
Video Credit: Molecular Devices UK Ltd
Ensure Compliance with Confidence
SoftMax® Pro GxP enables laboratories to comply with the EU GMP Annex 11 and FDA 21 CFR Part 11 requirements by deploying audit trails, secure electronic records, electronic signatures, and validation tools to ensure compliant workflows.
Maintain Data Integrity
The software has a paperless document management workflow that monitors document status throughout development, review, approval, and use. Structured release processes and controlled eSignatures help maintain data integrity across projects.
Streamline Regulated Workflows
SoftMax® Pro GxP helps in minimizing manual effort through features such as role-based permissions, automated save functions, and project management capabilities. This enables users to follow approved processes and meet compliance requirements.
Features
Complete Audit Trail
This feature monitors and records user details, data, and document changes, including date and time stamps, signature details, and read results, to provide full traceability.
Simplified User Administration
This ensures user management via Windows Active Directory or GxP Admin software, simplifying control of user access, security settings, and password policies.
Automatic Data Protection
New documents must be saved before making any changes. Automatic saving before and after reads eliminates data loss and improves consistency in the record.
Structured Project Management
Users can be assigned to projects with defined roles and permissions to ensure controlled workflows. Predefined roles help labs deploy compliant processes efficiently.
Secure Electronic Signatures
Secure signatures support approval processes and compliant document review. By implementing standardized signing workflows, data integrity can be maintained.
Flexible Data Export
Data can be automatically exported in various formats, including XML, to integrate with SDMS and LIMS platforms. The feature also helps in maintaining regulated reporting workflows.