Become compliant with FDA 21 CFR Part 11 and EudraLex Annex 11 software validation
SoftMax® Pro GxP Software is the latest, most secure software to achieve full FDA 21 CFR Part 11 and EudraLex Annex 11 compliance with streamlined workflows to ensure data integrity. Every step is optimized to simplify analysis and reporting to support our microplate readers.
Track and record all changes
The system audit trail tracks all changes including date and time stamps, username, user ID, section statements, signature information and read results.
Maintain data integrity
The paperless, document status system maintains data integrity with control over eSignatures and document workflows. Project teams can track documents while they are moving through development, review, release, and usage in a controlled environment.
Kickstart your compliance journey with our “GXP Starter Bundle”
For researchers working in GLP or GMP laboratories, achieve full GxP compliance with our turnkey solution:
- SpectraMax Microplate Reader – Choose from our extensive SpectraMax® line of user-friendly microplate readers.
- SoftMax® Pro GxP Software is the latest, most secure software to achieve full FDA 21 CFR Part 11 and EudraLex Annex 11 compliance with streamlined workflows to ensure data integrity.
- SoftMax® Pro Software Validation Package provides the most comprehensive documentation and tools available to validate GxP administrator features, software operation, and analysis functions for microplate reader instrumentation.
- Software Installation & Training – Our software installation services verify and document that required components are installed to operational specifications.
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