Software Assurance
Non-Product Software
Ensure Operational Excellence With QDS’s Tailored Enterprise Software Assurance
In today’s complex and interconnected enterprise environments, ensuring the reliability, security, and compliance of both Commercial Off-The-Shelf (COTS) and custom software solutions is critical. Qualified Data Systems (QDS) offers specialized Software Assurance Services tailored for non-product software, focusing on enterprise, manufacturing, and laboratory settings. Our services are designed to help organizations optimize their software assets, ensure regulatory compliance, and maintain the highest standards of operational integrity.
Core Services
Non-Product Software Assurance
- Vendor Qualification and Risk Assessment: QDS conducts thorough assessments of COTS software vendors, evaluating their processes, security practices, and compliance with industry standards. This ensures that the software products you procure meet your organization’s quality and regulatory requirements.
- Requirements Definition and Validation: QDS works with your stakeholders to clearly define software requirements, ensuring that custom and COTS configured solutions meet the specific needs of your enterprise, manufacturing, or laboratory environment. We validate these requirements through rigorous testing and verification processes.
- Software Configuration and Integration: We provide expert guidance on the configuration and integration of COTS software within your existing IT infrastructure. Our services ensure seamless interoperability and optimal performance across your enterprise systems.
- Compliance Verification: Our team ensures that COTS configured software complies with relevant regulatory standards, such as FDA 21 CFR Part 11 for electronic records and signatures, ensuring that your software solutions are audit-ready.
- Regulatory Compliance and Documentation: QDS ensures that custom software solutions adhere to applicable regulations, including ISO 9001, ISO 27001, and other industry-specific standards. We provide comprehensive documentation to support regulatory submissions and audits.
Enterprise Software Assurance
- Enterprise Systems: QDS provides assurance services for Enterprise systems, ensuring that these critical software solutions are configured correctly, perform reliably, and integrate seamlessly with other enterprise applications.
- Data Integrity and Governance: We help organizations implement robust data integrity and governance frameworks to ensure that data managed by enterprise software is accurate, consistent, and secure. This is particularly important for life sciences where data accuracy is critical for compliance and operational effectiveness.
- Continuous Monitoring and Performance Optimization: Our continuous monitoring services track the performance and security of enterprise software, identifying potential issues before they impact operations. We offer performance optimization strategies to keep your software running at peak efficiency.
Manufacturing Software Assurance
- Manufacturing Execution Systems (MES) Validation: QDS offers validation services for MES software, ensuring that these systems operate effectively and comply with industry standards, such as ISA-95 and ISO 9001. Our validation processes are designed to reduce downtime and improve manufacturing efficiency.
- Automation and Control Systems: We provide assurance services for automation and control systems, including Programmable Logic Controllers (PLCs) and Supervisory Control and Data Acquisition (SCADA) systems. QDS ensures that these systems are reliable, secure, and compliant with relevant standards.
- Process Optimization and Continuous Improvement: QDS assists in the optimization of manufacturing processes by ensuring that software solutions are aligned with lean manufacturing principles, enabling continuous improvement and operational excellence.
Laboratory Information Management Systems (LIMS) Assurance
- LIMS Implementation and Validation: QDS offers comprehensive implementation and validation services for LIMS, ensuring that these critical systems meet regulatory requirements such as GLP, GMP, and GCP. Our validation services cover software configuration, data management, and system security.
- Data Integrity and Compliance: We focus on ensuring data integrity within LIMS, helping organizations manage and maintain accurate, reliable data for research, testing, and compliance purposes. Our services include data migration, validation, and audit readiness.
- System Integration and Optimization: QDS provides integration services to ensure that LIMS are fully integrated with other laboratory and enterprise systems, optimizing workflows and data exchange. We also offer performance optimization services to enhance the efficiency of your laboratory operations.
Value Proposition
QDS’s Software Assurance Services for non-product software offer the following benefits:
Our services ensure that both COTS and custom software solutions meet stringent regulatory and security standards, reducing the risk of non-compliance and security breaches.
By optimizing software configurations, integrations, and performance, we help organizations streamline operations, reduce downtime, and improve overall productivity.
QDS tailors its services to meet the unique needs of your enterprise, manufacturing, or laboratory environment, ensuring that our solutions are scalable and aligned with your organizational goals.
Our comprehensive risk assessment and management services help organizations identify and mitigate potential risks associated with software implementation and use, ensuring long-term stability and reliability.