- Home
- Products
- Microplate Readers
- Microplate Software
- SoftMax Pro GxP Software
SoftMax Pro GxP Software

Meet FDA guidelines in GMP/GLP labs with complete validation tools

Now
Maintaining data integrity compliance in a regulated GxP environment

The Science Explorer interviews Timothy Bolus.
Learn moreBecome compliant with FDA part 11 software validation
SoftMax® Pro 7.1.1 GxP Software is the latest, most secure software to achieve full FDA 21 CFR Part 11 compliance with streamlined workflows to ensure data integrity. Every step is optimized to simplify analysis and reporting to support our microplate readers.
Our expert team will partner with you to set up single- or enterprise-level software, and provide IQ OQ services using our validation package to establish full compliance on your microplate readers. Major data privacy and security improvements support the latest GDPR regulations.
See how SoftMax Pro GxP Compliance Software meets 21 CFR Part 11 and EU GMP Annex /11 requirements.
-
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.

SoftMax Pro 7.1 GxP Software
GxP compliance software features
-
Windows Active Directory
User administration in a Windows Active Directory or via the GxP Admin software simplifies defining password criteria, reset and change periods, and reduces the amount of IT support.
-
Improved auto-save functionality
New documents must be saved before they can be modified and documents are automatically saved before and after a read to prevent the loss of data.
-
Improved signing process
Users can only sign a single pre- and post-release statement per document contributing to data integrity.
-
Projects feature
Project teams can be created where users can be assigned to different projects with different roles but can't have different roles in the same project.
-
Roles and permissions
Permissions are defined on a per role basis and assigned accordingly to users within projects to maintain a structured system. Three predefined roles—Scientist, Lab Manager, Lab Technician—accommodate the document release workflow, allowing first-time users to get started quickly.
-
Auto-export function
Data can be exported to a location outside the database and various file formats are available to support the import into other applications such as LIMS (Laboratory Information Management System) or SDMS (Scientific Data Management System). XML is supported for data export and auto export.
Proven GxP solutions to assure data integrity and compliance
Our comprehensive suite of proven compliance solutions for GMP/GLP labs can advance your efforts to quickly and confidently establish a compliant laboratory.
- Best-in-class microplate readers and washers support all your assay needs
- IQ/OQ/PM services preserve instrument documentation in a digital and compliant format
- Software installation services verify and document that required components are installed to operational specifications
- Software validation service supports FDA 21 CFR Part 11 guidelines
- Validation plates test the performance of your microplate reader using traceable materials for reliable results

-
Technical Guide
Software compliance for microplate readers in GMP/GLP labs
Software compliance for microplate readers in GMP/GLP labs
Achieve full FDA 21 CFR Part 11 compliance with streamlined workflows to ensure data integrity on your microplate readers.
-
Brochure
SoftMax Pro 7.1.1 GxP Data Acquisition and Analysis Software
SoftMax Pro 7.1.1 GxP Data Acquisition and Analysis Software
Meet FDA guidelines in GMP/GLP labs with complete validation tools.
Applications of SoftMax Pro GxP Software
Specifications & Options of SoftMax Pro GxP Software
Helpful Tips:
- To prevent data loss, turn off all sleep and hibernation settings for the hard disk, the CPU, and the USB ports
- Disable automatic Windows Updates
- Update Windows manually when the instrument isn't being used by the software; these options can be enabled in Windows Control Panel
Note: Installing and using the SoftMax Pro Software on the Windows XP operating system is no longer supported. The software is neither tested nor validated on Windows XP.
Resources of SoftMax Pro GxP Software
Technical Guide
Software compliance for microplate readers in GMP/GLP labs
Software compliance for microplate readers in GMP/GLP labs
Achieve full FDA 21 CFR Part 11 compliance with streamlined workflows to ensure data integrity on your microplate readers.
Brochure
SoftMax Pro 7.1.1 GxP Data Acquisition and Analysis Software
SoftMax Pro 7.1.1 GxP Data Acquisition and Analysis Software
Meet FDA guidelines in GMP/GLP labs with complete validation tools.
eBook
Software compliance for GMP/GLP labs
Software compliance for GMP/GLP labs
Become 21 CFR Part 11 compliant with SoftMax Pro 7.1.1 GxP Software.
White Paper
GxP regulated industry assessments of SoftMax Pro Software
GxP regulated industry assessments of SoftMax Pro Software
This document outlines references to 21 CFR Part 11 and EudraLex Annex 11 and how they apply to the implementation of SoftMax® Pro GxP Data Acquisition and Analysis Software in regul…
White Paper
GxP regulated industry assessments of microplate readers
GxP regulated industry assessments of microplate readers
This document outlines references to 21 CFR Parts 58, 211 and 820 and EudraLex Annex 15 to assess the implementation of Molecular Devices microplate readers in regulated environments…
Flyer
Instrument validation services
Instrument validation services
Installation, operational qualification, preventive maintenance
Assure ongoing compliance of your Molecular Devices microplate readers and washers and be audit ready with compr…Brochure
GxP compliance solutions for GMP/GLP labs
GxP compliance solutions for GMP/GLP labs
Molecular Devices is a leader in comprehensive compliance solutions with microplate detection systems and software. Combined with validation services and support, our solutions assur…
Infographic
Streamline your compliance journey in GMP/GLP labs
Streamline your compliance journey in GMP/GLP labs
Comprehensive OEM operational qualification and repair coverage for microplate readers and washers.
Flyer
Software validation service
Software validation service
Our on-site SoftMax® Pro GxP Software validation service supports FDA 21 CFR Part 11 guidelines and is conducted by our certified Field Service Engineer (FSE). Each step in the proce…
Flyer
Service plans to maximize your productivity
Service plans to maximize your productivity
Each instrument’s functional level will evolve over its operational life cycle—changing with the laboratory environment, assay conditions, usage, role in experimental workflow, compl…
Flyer
SoftMax Pro 7.1.1 GxP Compliance Software Suite - Purchase Guide
SoftMax Pro 7.1.1 GxP Compliance Software Suite - Purchase Guide
The SoftMax® Pro 7.1.1 GxP Compliance Software Suite can scale from a single computer to a multi-computer networked environment. Consult with your Molecular Devices representative an…
Flyer
SoftMax Pro 7.1.1 GxP Software - Comparison Sheet
SoftMax Pro 7.1.1 GxP Software - Comparison Sheet
SoftMax Pro 7.1 GxP Software is the latest, most secure software to achieve full FDA 21 CFR Part 11 compliance with streamlined workflows to ensure data integrity.
Data Sheet
Software Validation Package
Software Validation Package
For researchers working in GLP or GMP laboratories, the SoftMax® Pro Software Validation Package provides the most comprehensive documentation and tools available to validate GxP pro…
Data Sheet
SpectraTest Validation Packages
SpectraTest Validation Packages
Microplate readers from Molecular Devices are designed to provide consistent performance for many years. In keeping with best practices, reader performance should still be validated…
Data Sheet
SoftMax Pro 7.1.1 GxP Software
SoftMax Pro 7.1.1 GxP Software
Download this datasheet to learn more about SoftMax Pro 7.1.1 GxP Software with compliance-focused software and tools .


Maintaining data integrity compliance in a regulated GxP environment

Urban myths of microplate readers: Read-Copy-Paste-Analyze. Repeat... Sound familiar?

Urban myths of microplate readers: Beyond the basics - real time, resolving time and transferring energy

Urban myths of microplate readers: “Optimization? But the manual says I need to be excited at 490nm!"

Urban myths of microplate readers: OD, RFU or RLU - What exactly are they and why bigger is not always better!

Urban myths of microplate readers: Which microplate reader? Decisions, decisions and how to be less confused!

GxP compliance solutions for GMP/GLP labs

How a complete set of software and validation tools for microplate readers can help GMP/GLP labs meet FDA data integrity guidelines

SoftMax Pro 7.1 GxP Software
SoftMax Pro GxP Software compliance for microplate readers
- Dated: Nov 27, 2020Publication Name: Springer
Meeting technical challenges for protein characterization and surrogate equivalence studies that resulted from insecticidal protein co-expression in maize event MZIR098
Safety assessment of genetically modified plants includes protein characterization to confirm the intended trait protein expression. In addition, to conduct safety tests, the large amount of purified protein needed is usually met through the use of a surrogate, microbially produced protein source. View moreSafety assessment of genetically modified plants includes protein characterization to confirm the intended trait protein expression. In addition, to conduct safety tests, the large amount of purified protein needed is usually met through the use of a surrogate, microbially produced protein source.
- Dated: Nov 27, 2020Publication Name: bioRxiv
NVX-CoV2373 vaccine protects cynomolgus macaque upper and lower airways 3 against SARS-CoV-2 challenge
There is an urgent need for a safe and protective vaccine to control the global spread of SARS-CoV-2 and prevent COVID-19. Here, we report the immunogenicity and protective efficacy of a SARS-CoV-2 subunit vaccine (NVX-CoV2373) produced from the full-length SARS-CoV-2 spike (S) glycoprotein stabilized in the prefusion conformation. View moreThere is an urgent need for a safe and protective vaccine to control the global spread of SARS-CoV-2 and prevent COVID-19. Here, we report the immunogenicity and protective efficacy of a SARS-CoV-2 subunit vaccine (NVX-CoV2373) produced from the full-length SARS-CoV-2 spike (S) glycoprotein stabilized in the prefusion conformation.
Contributors: Mimi Guebre-Xabier, Nita Patel, Jing-Hui Tian, Bin Zhou, Sonia Maciejewski, Kristal Lam, Alyse D. Portnoff, Michael J. Massare, Matthew B. Frieman, Pedro A. Piedra, Larry Ellingsworth, Gregory Glenn, Gale Smith
Go to article - Dated: Jul 12, 2019Publication Name: Nature
Inside out: optimization of lipid nanoparticle formulations for exterior complexation and in vivo delivery of saRNA
Self-amplifying RNA (saRNA) is a promising biotherapeutic tool that has been used as a vaccine against both infectious diseases and cancer. saRNA has been shown to induce protein expression for up to 60 days and elicit immune responses with lower dosing than messenger RNA (mRNA). Because saRNA is a large (~9500 nt), negatively charged molecule, it… View moreSelf-amplifying RNA (saRNA) is a promising biotherapeutic tool that has been used as a vaccine against both infectious diseases and cancer. saRNA has been shown to induce protein expression for up to 60 days and elicit immune responses with lower dosing than messenger RNA (mRNA). Because saRNA is a large (~9500 nt), negatively charged molecule, it requires a delivery vehicle for efficient cellular uptake and degradation protection.
Contributors: Anna K. Blakney, Paul F. McKay, Bárbara Ibarzo Yus, Yoann Aldon & Robin J. Shattock
Go to article
Software and installation service
SoftMax® Pro GxP Software: Windows 10 compatible
Latest version of SoftMax Pro 7 GxP Software Suite includes: 3 software installations for each user license, GxP Admin Software, software IO/OQ validation package DVD, user license certificate, compliance certificate
Single computer setup | Multi computer setup |
Part number: SMP7X GXP SINGLE COMP * | Part number: SMP7X GXP SERVER * |
Installation service | |
Part number: SMPGXP-INSTALL1COMP-OS ** | Part number: SMPGXP-INSTALLSVR-OS ** Part number: SMPGXP-INSTALLADVSVR-OS (for custom server installation) |
Additional user license purchases | |
Part number: SMP GXP ADD | Part number: SMP GXP SVR ADD |
*Requires purchase of a minimum of 3 licenses **Applies to initial purchase only |
Related Products & Services of SoftMax Pro GxP Software
How can we help advance your next big discovery?
Our highly-qualified teams are on the frontlines with our customers, conducting remote or on-site product demonstrations, webinars, and more to help you solve your tough research challenges. How can we help you today?
How can we help advance your next big discovery?
Our highly-qualified teams are on the frontlines with our customers, conducting remote or on-site product demonstrations, webinars, and more to help you solve your tough research challenges. How can we help you today?