Your path to compliance on a microplate reader
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SoftMax® Pro GxP Software contains everything that is required to set up your plate reader software for FDA21 CFR Part 11 compliant work.
SoftMax® Pro 7.1 GxP SoftMax Pro Validation Package Certificate of License Certificate of Compliance GxP Admin Software
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SoftMax Pro 7.1 GxP
Regular SoftMax Pro application where user-name and password are required to login.
SoftMax Pro Validation Package
Provides comprehensive documentation and tools to validate SoftMax Pro Software and GxP Admin features.
GxP Admin software
Please see below for more information on the individual components.
GxP Admin
GxP Admin interfaces with the Microsoft SQL Express database which is automatically installed. The user interface called GxP Admin- Portal is installed separately in the next step. There won’t be an icon for GxP Admin only for the GxP Admin manager.
GxP Admin – Portal
GxP Admin – Portal is the user interface and access point to GxP Admin and can be installed separately on any computer that has access to the same network where the GxP admin manager is installed.
GxP Admin – EDB converter tool
For existing SoftMax Pro GxP customers, the EDB converter tool is used to easily convert legacy EDB user account files from GxP Admin 2.0 to a format that can be imported into the new GxP Admin 3.0.
GxP Admin – Backup
Support tool to backup the SQL database for single workstation installations. Enterprise customers usually have backup processes in place.
Certificate of Licenses
Contains a User License Code that permits you to add as many users in GxP admin as you have ordered.
Certificate of Compliance
Certifies that SoftMax Pro GxP was tested and verified to be in compliance with all of our internal, applicable manufacturing and quality requirements.
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SoftMax Pro GxP can be set up on a stand-alone computer. Our technical support team will remotely walk you through the installation.
Single computer setup
User accounts, data and the audit trail information are stored in a Microsoft SQL database (instance of Microsoft SQL Express database included). GxP administrator creates password protected user accounts and assigns appropriate login permissions for users.
Network setup
GxP Admin stores data and user information in a Microsoft SQL database. All client computers around the world connect to the same database which stores data and user information. Administrators can curate the database from anywhere within the network.
Network based enterprise solution
Stand-alone computer
Ensure ongoing compliance for your Molecular Devices microplate readers and be audit-ready with our comprehensive digital IQ/OQ/PM services.
Qualifying your Molecular Devices microplate readers in GMP or GLP environments can now be done with greater reliability, security, and convenience. Compliance assurance digital IQ/OQ/PM services are a unique qualification solution that preserves the documentation of legacy services in a digital and compliant format.
The SoftMax Pro Validation Package provides comprehensive documentation and tools to validateSoftMax Pro Software and GxP Admin features.
Shorten validation from 6 months to 3 days
Streamline confirmation of data acquisition andanalysis features
Best-in-class documentation
Ensuring consistency, reliability, quality, and integrity of your experiments is of utmost importance, but may consume up to 6 months to adequately certify and document experimental test procedures. The SoftMax Pro Validation Package trims validation time from 6 months to 3 days using a fully-integrated electronic manual that mirrors the validation process in a regulated laboratory.
Streamline confirmation of data acquisition and analysis
Step-by-step instructions guide new and experienced researchers through Installation Qualification (IQ) and Operational Qualification (OQ) procedures. This is complemented by comprehensive tools to confirm basic or custom calculations, curve fits, and parallel line analysis. Sample data sets also shorten the time necessary to authenticate and compare analysis algorithms within SoftMax Pro Software to traditional programs including Microsoft Excel GraphPad Prism, and other text-based programs (.txt).
All worksheets are available as Microsoft Word documents so you can tailor validation to specific applications or set the foundation for Performance Qualification (PQ) procedures. Regardless of the application, complete and accurate “hard copies” of required IQ/OQ records can be printed to document activities for your regulated environment. Answers to frequently asked questions guide new users on how to implement electronic records and signatures within SoftMax Pro GxP Software.
The SpectraTest® ABS1, FL1, and LM1 Validation Plates provide automated, comprehensive, and traceable validation of microplate reader performance for absorbance, fluorescence, and luminescence read modes.
Automated for ease of use
NIST traceability of SpectraTest ABS1 Validation Plate
Recertification service
All test measurements and calculations are handled automatically by the SoftMax Pro Software protocols. Should any of the measurement parameters fall outside defined limits, a test failure is reported with the suspect parameters identified.
Each filter is individually tested across all eight channels of the plate. Calibration of the plate’s filter standards is accomplished through the use of an instrument calibrated with primary NIST standards.
To maintain confidence in the standards, we recommend having validation plates recertified at one-year intervals. Validation plates sent to us are disassembled, cleaned, calibrated, recertified according to ISO17025, and returned with a new certificate of calibration.
