SoftMax Pro GXP Compliance Software

NegotiableUpdate on 01/21

Model

Nature of the Manufacturer: Producers

Product Category

Place of Origin

Online Consult

Overview

Product Details

Complies with the FDA Part 11 verification process for compliant software

SoftMax ® Pro 7.1.1 GxP software is MD compliant software that meets the requirements of FDA 21 CFR Part 11, simplifies workflows, and ensures data integrity. Each step has been optimized to simplify the analysis process and report time, and the software supports all of our current microplate readers.

Our professional technical team will assist you in setting up personal or enterprise software, using our validation files to provide IQ OQ services and ensure the compliance of your microplate reader. The privacy and security mechanisms for important data comply with the requirements of GDPR regulations.

Please refer to how SoftMax Pro GxP compliance software complies with 21 CFR Part 11 and EU GMP Annex/11 requirements.

Track and record all changes

The system audit tracking function can record all changes in information, including date and time, username, user ID, s comments, signature information, and detection results.
Maintain data integrity

Adopting paperless document format, the system maintains data integrity by controlling electronic signatures and document workflow. The project team can track the development, review, release, and usage of documents in a controlled environment.

SoftMax Pro 7.1GxP Enterprise Edition software

GxP Compliance Software Features

Windows Active Directory

User management in Windows Active Directory or through GxP Admin software simplifies the definition of password reset and change cycles, reducing the workload of laboratory personnel and IT.
Improve the automatic save function

Before conducting the experiment, it is necessary to save the new file before making any modifications, and the file will be automatically saved before and after testing to prevent data loss.
Improve the signature process

For each file, users are required to sign a pre release and post release statement to ensure the integrity of their data.
Based on the characteristics of project allocation permissions

Project teams can be created where users can be assigned to different projects with different roles, but cannot have multiple roles in the same project.
Roles and Permissions

Assigning corresponding permissions to roles in each project has the advantages of being more stable, scientific, and compliant. The three predefined roles of scientist, laboratory administrator, and laboratory technician are suitable for the workflow of document publishing, allowing new users to quickly get started.
Automatic data export function

It is possible to export data to a location outside the database and provide various file formats to support importing into other application systems, such as Laboratory Information Management System (LIMS) or Scientific Data Management System (SDMS). Support XML for data export and automatic export.