SBS Quality Management Software
The SBS QMS Suite is composed of five interrelated software modules designed to enhance Quality compliance efficiency.
1) The SBS Quality Database includes tools for managing CAPA and 8D corrective actions, overseeing nonconformance issues, conducting risk analyses such as FMEA and SWOT, handling various audit management needs, and ensuring Environmental Health and Safety (EHS/HSE) compliance.
2) SBS Ground Control focuses on managing employee training through a Learning Management System (LMS), offering self-paced training options, and providing document control features.
3) SBS Asset Tracking Database oversees calibrated equipment, preventive maintenance schedules, and comprehensive asset inventory management.
4) The SBS Inspection Database captures and records inspection data for incoming materials, in-process checks, and final product assessments, allowing for the generation of real-time SPC charts, development of inspection and control plans, and archiving data for future statistical evaluations.
5) The SBS Vendor Management maintains an approved vendor list (AVL), formulates vendor qualification plans, and tracks the qualification history of suppliers.
Each of these modules may be purchased individually or in any combination to meet your needs.
On-premise and cloud-based options are available.
Free demos are available for download or contact us for a cloud-based demo.
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Qualio
Qualio is a unified quality and compliance platform that helps growing life sciences companies scale faster while staying continuously audit- and inspection-ready. Medical device, digital health, biotech, and pharma teams use Qualio to replace manual processes and disconnected tools with a single source of truth for quality, regulatory readiness, and risk.
With a modern eQMS at the foundation and Compliance Intelligence layered on top, Qualio moves teams beyond point-in-time audits. Automated gap analysis, cross-standard evidence mapping, and real-time readiness dashboards provide confidence that the organization is prepared today—not just when auditors arrive.
Qualio centralizes document control, training, CAPA, change management, supplier quality, and design controls, linking them directly to regulatory requirements and product lifecycle data. Executive-ready views show compliance health by standard, region, and product, turning regulatory readiness into a measurable business capability instead of a black box.
Compliance Intelligence continuously monitors for risk, highlights gaps early, and prioritizes remediation so teams focus effort where it matters most. Pre-validated regulatory frameworks are maintained as requirements evolve, reducing reliance on consultants and avoiding duplicate work as companies expand.
The result is faster market entry, lower compliance cost, reduced risk of findings or recalls, and confident, risk-managed growth.
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Intelex
Intelex provides an integrated software solution designed to manage Environmental, Health, Safety, and Quality (EHSQ) initiatives effectively. Its versatile platform is engineered to gather, control, and analyze EHS and Quality data in a comprehensive manner. This solution is accessible on any device, aligning perfectly with the demands of your workplace.
Utilizing Intelex allows your organization to:
Enhance the results of your EHSQ program by overseeing workflows for improved performance and control.
Identify trends and behaviors through effective goal-setting to enrich insights and enhance decision-making within your EHSQ framework.
Reduce incidents and minimize administrative burdens by adeptly supervising, managing, refining, and deriving insights from your safety data with our user-friendly safety software.
Streamline the management and reporting of air, water, and waste emissions while overseeing environmental outputs to achieve sustainability goals.
Encourage continuous quality improvements by effortlessly recording and tracking all instances of nonconformity within a centralized, web-based system, allowing for trend analysis across multiple departments or locations.
Intelex also aids in navigating compliance with global standards and regulations like OSHA, WCB, ISO 45001, EPA, and ISO, fostering a culture of safety and accountability within your organization. By leveraging these tools, companies can not only comply with regulations but also drive long-term growth and sustainability.
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DataLyzer FMEA
FMEA plays an essential role in mitigating risks and reducing costs associated with quality. DataLyzer FMEA provides a comprehensive suite that includes DFMEA, Process Flow, PFMEA, and Control Plan, all designed to streamline the synchronization of the necessary steps. From the Control Plan, the setup for SPC can be generated automatically, enhancing efficiency. The platform boasts numerous features such as reference or Foundation FMEAs, various criteria or classification sets, comprehensive authorization, document management, action management, ballooning import, automatic translation, and reporting, along with ITAR configuration, among others. By utilizing DataLyzer FMEA, engineers can save substantial time as it eliminates the need for repetitive tasks. Adhering closely to the methodologies outlined in VDA AIAG and RM13004, DataLyzer FMEA also integrates seamlessly with DataLyzer SPC software, ensuring a cohesive workflow across quality management processes. This integration not only enhances productivity but also contributes to maintaining high industry standards.
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