It is crafted to ensure full compliance with FDA 21 CFR Part 11 and EudraLex Annex 11, incorporating enhanced security features. The streamlined workflows prioritize data integrity, and every aspect of the software is optimized to simplify the process of analysis and reporting, providing comprehensive support for microplate readers.
Our microplate readers with microplate manager software offer a comprehensive suite of ready-to-use protocols, analysis algorithms, and a choice of 21 different curve fit options. Each step in the process is fine-tuned for flexible data obtained from microplate reading or imported from external sources, streamlining the analysis and reporting procedures. For regulated laboratories, we provide compliance tools that ensure an end-to-end chain of custody. The system audit trail meticulously records all changes, capturing date and time stamps, usernames, user IDs, section statements, signature details, and read results. This ensures transparency and accountability in the data management process. Our paperless document status system grants control over eSignatures and document workflows to help maintain data integrity. Project teams can monitor documents as they progress through development, review, release, and usage within a controlled environment. User permissions are defined based on roles, such as Scientist, Lab Manager, and Lab Technician, facilitating a structured system for document release workflows. Our experienced team collaborates with you to set up the software at single and enterprise levels. We also offer IQOQ services, leveraging our validation package to establish complete compliance for your microplate readers. Notably, our software incorporates major enhancements in data privacy and security to align with the latest GDPR.
Features
Essential features our Microplate Reader Analysis Software
- Experience the flexibility of our software with over 160 protocols featuring preconfigured assay parameters for a diverse range of common assays, including comprehensive protocols for our entire array of reagents, SpectraTest® Validation Plates, and adapter plates.
- Controlled user access is ensured through a granular permission structure, offering unique logins with electronic signature support for verification, authorization, and approval, all meticulously documented in audit trails.
- Effortlessly conduct simplified cross-plate analysis and interpolation with automatic calculations for relative potency, EC50, and Z factors.
- The software facilitates controlled user access through a detailed permission structure, accompanied by unique logins and electronic signature support for verification, authorization, and approval, all of which are meticulously tracked in audit trails.
- Seamlessly export data to external locations and choose from various file formats, supporting integration with applications like LIMS (Laboratory Information Management System) or SDMS (Scientific Data Management System). XML support ensures efficient data export and automated exports.
- Tailor your assay workflow by building custom processes, executing multitask kinetics, and leveraging the discontinuous kinetics feature for the ability to pause and resume kinetic reads.
- The software also boasts an extensive suite of microplate reader validation tools, significantly reducing both the cost and time of validation—up to 50% compared to using multiple platforms for data collection and analysis.
Applications
Applications of Microplate Reader Analysis Software
- Our comprehensive software package is a crucial tool for pharmaceutical laboratories striving to adhere to stringent regulatory guidelines such as FDA 21 CFR Part 11 and EudraLex Annex 11. This software not only ensures full compliance but also streamlines workflows, enhancing data integrity throughout the analysis and reporting processes.
- Beyond regulatory compliance, SoftMax Pro GxP Software serves as an advanced data management and analysis tool for research institutions, aiming to enhance data accuracy, collaboration, and overall efficiency in their scientific endeavors.
FAQs
What is SoftMax Pro GxP Software used for?
The latest version of SoftMax Pro GxP Software is designed for microplate reader control and data analysis, ensuring compliance with FDA 21 CFR Part 11 and EudraLex Annex 11. It simplifies analysis, supports various assays, and offers tools for streamlined workflows in regulated environments.
How does the software address data integrity concerns in laboratories?
The software maintains data integrity through a paperless document status system, granular permission structures, and an audit trail that records all changes, providing control over eSignatures and document workflows.
Can SoftMax Pro GxP Software be customized for specific research projects?
Yes, the software features allow users to build custom assay workflows, create project teams with different roles, and export data in various formats, supporting seamless integration with other applications such as LIMS and SDMS.
What support does the software offer for compliance validation in GMP/GLP labs?
SoftMax Pro GxP Software offers a comprehensive validation package, including IQ OQ services, to achieve full compliance. This helps laboratories meet the regulatory requirements of GMP/GLP and ensures data privacy and security in accordance with GDPR.
How does SoftMax® Pro Software simplify microplate data acquisition and analysis?
SoftMax® Pro Software simplifies microplate data acquisition and analysis by offering preconfigured protocols and customizable assay workflows. Whether using built-in protocols or setting custom experiment parameters, the software optimizes every step for efficient data analysis and reporting.
What types of data sources does the software support for analysis?
The data analysis software supports versatile data sources, allowing users to import raw data in microplate format from any scientific instrument. This capability, combined with consistent data evaluation methods, reduces errors and streamlines the analysis of complex data.
How does SoftMax Pro Software assist in project management and reporting?
SoftMax Pro Software facilitates project management by grouping multiple plate reads in one protocol. The software enables users to display results, pass/fail statements, mini graphs, and images in the notes section for easy viewing, providing a comprehensive overview of overall project results.
What security features does the software offer for electronic record-keeping in regulated laboratories?
SoftMax® Pro Software ensures secure electronic record-keeping in regulated laboratories through controlled user access, employing a granular permission structure and unique logins with electronic signature support. This includes audit trails for verification, authorization, and approval, maintaining the integrity of data and compliance with regulatory requirements.
Is the software compatible with different microplate formats?
Yes, SoftMax® Pro Software is designed to be highly versatile and is compatible with various microplate formats. It supports the import of raw data in microplate format from any scientific instrument, providing flexibility in data analysis for different experimental setups and assay configurations.