SoftMax Pro is a leading software for data acquisition and analysis in the pharmaceutical and biotechnology industries. Electronic signatures, audit trails, and data integrity capabilities help meet industry standards. SoftMax Pro’s data security includes backup, encryption, and user access control, which help ensure the reliability and quality of experimental data and further meet industry standards.
Though SoftMax Pro has features designed to meet regulatory standards like Food and Drug Administration (FDA) 21 CFR Part 11, Arbour Group’s specialized services focus on ensuring 21 CFR Part 11 requirements are met, thus ensuring SoftMax Pro performs as expected. Arbour Group’s expertise in FDA 21 CFR Part 11, GxP, and industry standards ensures SoftMax Pro has adequate provisions related to electronic signatures, audit trails, security access and data integrity.
The Importance of SoftMax Pro in Regulated Industries
SoftMax Pro provides robust data acquisition and analysis capabilities critical for evaluating biological data. It supports various immunoassays crucial to identifying antigens, antibodies, and proteins. SoftMax Pro can also handle data from cell-based assays to provide gene therapy insight at the cellular level.
It is essential that regulatory requirements are met to ensure that data used in drug development is reliable, traceable, and meets quality standards. Data validation and integrity regulatory requirements must be met when supplying data for FDA, Biologics License Applications (BLA), and Investigational New Drug (IND) applications. Risks of non-compliance can lead to FDA-issued warning letters or even fines that can delay product approvals and require costly efforts to remedy. Non-compliant data submissions can result in rejected BLA or IND applications, delaying the drug development timeline and increasing costs.
Arbour Group’s SoftMax Pro Validation Services
Comprehensive Validation Solutions:
- SMP Data Acquisition: Validating data acquisition processes ensures the accuracy, reliability, and compliance of data used in research, development, and regulatory submissions, especially in the pharmaceutical and biotech industries.
- Curve Fitting Calculations: Validating curve fitting algorithms provide reliable data interpretation where data accuracy impacts decision-making, regulatory compliance, and product development. Validation mitigates risks associated with incorrect conclusions, safeguarding the quality and success of scientific clinical research.
- Formula Enhancements: Validating custom formulas within SoftMax Pro to meet specific research needs ensures that the data analysis meets specific research needs while maintaining accuracy, reliability, and compliance with regulatory requirements. A SoftMax Pro validation package includes a Validation report to provide a clear validation process record as evidence of compliance for audits and regulatory submissions.
- SMP Configuration: Validating software configurations optimizes performance and ensures compliance by configuring the software to specifications that involve performance, security, user access, and data handling. It also ensures that data integrity is maintained throughout software operations without data loss, corruption, or unauthorized modifications.
- Code Reviews: An essential practice in software development that contributes to maintaining software integrity and preventing errors. They involve systematically examining code to identify bugs, ensure compliance with coding standards, and improve software quality. Code reviews promote a collaborative culture that continuously enhances team skills and system quality.
- Standard Operating Procedures (SOPs): Developing and validating SOPs to ensure consistent and compliant use of SoftMax Pro ensures consistent, reliable, and compliant operations in regulated environments like biotech and pharmaceuticals. SOPs provide guidance and detailed instructions on implementing the software correctly to maintain data integrity and adhere to regulatory requirements.
- Graphical Data Presentation: Validating data visualization tools ensures that clear and accurate data is presented accurately and reliably. The SoftMax Pro validation process involves assessing the tool’s capabilities to accurately represent data, confirm compliance, and provide outputs that meet user needs.
- Trending Reporting Tables: A SoftMax Pro software validation package may involve validating trending analysis and reporting tables to support informed decision-making. Identify patterns, monitor performance, and provide actionable insights from data to ensure the validity of tools with comprehensive validation services.
- Transitioning Analytical Benchtop Methods: Transitioning traditional analytical methods to digital protocols within SoftMax Pro software validation involves ensuring the new digital workflows' accuracy, consistency, and compliance. The transition improves data handling, reduces manual errors, enhances efficiency, and meets regulatory requirements.
- Assay Validity Determination: A SoftMax Pro software validation package validates assay methods within SoftMax Pro to meet acceptance criteria. Ensure processes are robust, reliable, and compliant with regulatory standards to support high-quality data generation and hold confidence in results implemented in critical decision-making research and development.
- AI Model Data Set Creation and SDLC Documentation: Validating AI models and maintaining comprehensive Software Development Life Cycle (SDLC) documentation ensures that AI systems perform ethically, accurately, and reliably. Since AI models have significant impacts in the life sciences, effective validation assists in achieving high performance, and thorough documentation supports transparency and effective management of the development lifecycle.
- Validation and Data Integrity Activities: SoftMax Pro GxP validation and meeting FDA 21 CFR Part 11 regulatory standards for electronic records and signatures assists in ensuring data integrity throughout the SoftMax Pro validation process. Maintain the accuracy and compliance of data generated and managed with SoftMax Pro to support the credibility of research and ensure adherence to regulatory standards.
Benefits of Partnering with Arbour Group
Arbour Group’s team of experts in regulatory requirements and best practices ensures your organization meets all necessary standards. Arbour Group offers customized solutions tailored to meet specific requirements. From implementing a SoftMax Pro microplate reader validation protocol to ongoing monitoring and maintenance, Arbour Group ensures reliable and compliant results for experiments and analyses.
Whether a local or cloud-based SoftMax Pro installation, Arbour Group’s SoftMax Pro software validation package has a flexible approach to ensure support and services best suited to an organization’s operational environment. Contact us today to learn more about Arbour Group’s SoftMax Pro validation package services.