SoftMax Pro GxP Software
SoftMax Pro GxP Software

SoftMax Pro GxP Software

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

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Become compliant with FDA 21 CFR Part 11 and EudraLex Annex 11 software validation

SoftMax® Pro 7.2 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.

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

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

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.

GxP compliance solutions for GMP/GLP labs.

GxP compliance software features

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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.

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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.

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Improved signing process

Users can only sign a single pre- and post-release statement per document contributing to data integrity.

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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.

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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.

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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.

SoftMax Pro GxP: Your path to compliance

GxP Assessment Questionnaire for SoftMax Pro GxP Software

Market Requirements Assessment

This Market Requirements Assessment document is designed from supplier audit questionnaires to address SoftMax® Pro Data Acquisition and Analysis – GxP Edition Software as suitable compliance software.

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Functional Requirements Specification Assessment

This Functional Requirements Specification document is designed retrospectively to address SoftMax® Pro 7.2.x GxP Data Acquisition and Analysis Software as suitable compliance software.

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GxP Assessment Questionnaire for SoftMax Pro GxP Software

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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?

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Specifications & Options of SoftMax Pro GxP Software

Helpful Tips:

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.

SoftMax Pro GxP Software: Resources

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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-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