Softmax Pro GxP solutions for data integrity and compliance

Regulated labs must adhere to Good x Practice (GxP) standards, encompassing both Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP). Achieving GxP compliance requires adhering to 21 CFR Part 11 throughout regulated workflows.

This ensures quality assurance of microplate reader performance within operational specifications and guarantees data acquisition and analysis software compliance with Part 11 guidelines for electronic records and signatures.

Molecular Devices is a leader in comprehensive compliance solutions, offering microplate detection systems and software designed to meet these requirements. The solutions, combined with validation services and dedicated support, empower labs to confidently achieve and sustain data integrity.

Softmax Pro GxP solutions for data integrity and compliance

Image Credit: Molecular Devices UK Ltd

SoftMax® Pro 7.2 GxP Software represents cutting-edge secure software designed to attain complete compliance with FDA 21 CFR Part 11 and EudraLex Annex 11. Its streamlined workflows ensure robust data integrity throughout the process. Each step is meticulously optimized to simplify analysis and reporting, catering to the needs of the microplate readers.

The experts are dedicated to collaborating with users in configuring either single- or enterprise-level software solutions.

The company offers IQ OQ services utilizing the validation package, ensuring a comprehensive compliance setup for the microplate readers. Noteworthy data privacy and security enhancements align with the latest GDPR regulations, providing a robust framework for safeguarding sensitive information.

What are the benefits?

Softmax Pro GxP solutions for data integrity and compliance

Image Credit: Molecular Devices UK Ltd

Track and record all changes

The system audit trail monitors and records all modifications, capturing details such as date and time stamps, username, user ID, section statements, signature information, and read results.

Maintain data integrity

The digital document status system upholds data integrity by managing eSignatures and document workflows. Project teams can monitor the progress of documents as they traverse through stages of development, review, release, and control usage in a paperless environment.

Kickstart users’ compliance journey with the “GXP Starter Bundle”

For researchers operating in GLP or GMP laboratories, attain comprehensive GxP compliance through an all-in-one solution: SpectraMax Microplate Reader. Select from the diverse SpectraMax® range of user-friendly microplate readers.

SoftMax® Pro 7.1.2 GxP Software is the most recent and secure software, designed to comply completely with FDA 21 CFR Part 11 and EudraLex Annex 11. Its streamlined workflows are crafted to guarantee data integrity.

The SoftMax® Pro Software Validation Package offers the most extensive documentation and tools, validating GxP administrator features, software operation, and analysis functions specific to microplate reader instrumentation.

Software Installation and Training: The software installation services confirm and document the installation of necessary components to meet operational specifications.

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