SoftMax® Pro GxP Software

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.

• 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.

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.