QSI Technologies, Inc.

TMS Quality Compliance Software, developed by QSI Technologies, Inc., is an affordable, web-based quality management solution designed to help organizations manage business-critical information, streamline compliance processes, and improve operational efficiency. Founded in 1992 and headquartered outside of Philadelphia, Pennsylvania, QSI has worked with more than 1,000 quality and regulatory managers and maintains installations across the nation with users located around the globe. Notably, QSI leadership spent four years on the FDA committee that developed the very guidance documents and training used for translating FDA requirements into electronic systems — meaning critical policies, procedures, and controlled content are built directly into the platform.

TMS Quality Compliance Software takes a single, integrated approach to quality, risk, and compliance management, eliminating fragmented paper-based processes and reducing administrative burden. The platform is designed to serve organizations of all sizes across a wide range of industries, delivering cross-functional collaboration, automated workflows, and unmatched customer support from real, live human beings providing real-time solutions.

Industries Served

• Food & Beverage
• Pharma & Life Sciences
• General Manufacturing
• Government & Public Sectors
• Aerospace & Aviation
• Automotive

Core Software Features

• Document Management: Enables document collaboration with structured approvals and review cycles, and provides secure, permission-based access to controlled content.
• Training Management: Confirms that employees are qualified and competent for their assignments; Job Management ensures workers are properly trained before undertaking tasks.
• Forms and Workflow: Streamlines organizational processes through automated workflows and task action items with auto-notification, routing, and escalation.
• Quizzing & Certification: Supports employee knowledge verification and certification tracking.
• Change Control: Manages and documents changes to processes, procedures, and controlled documents.
• Audit Management: Simplifies audit readiness with comprehensive audit trails and reporting capabilities, including a seamless repository for internal and external audits.
• Electronic Signatures: Fully compliant with FDA 21 CFR Part 11, including date and time stamping.

Compliance Coverage

• FDA 21 CFR Part 11 (electronic records and signatures)
• FDA GxP standards including GMP, GLP, and GCP
• FDA FSMA (Food Safety Modernization Act)
• ISO Standards
• OSHA and EPA regulations

Key Platform Advantages

• Simplifies audit readiness and streamlines IT management
• Saves time by consolidating quality processes into a single solution
• Boosts ROI by reducing litigation risk, improving efficiency, and increasing corporate value
• Empowers employees and increases productivity by automating routine compliance tasks
• Automatic alerts notify users of review requirements and overdue tasks
• Offers flexible deployment platforms to suit varying organizational needs
• Leverages extensive FDA experience built directly into the solution
• Manages risks and increases organizational oversight

Professional Services

• Software installation and implementation
• TMS training programs
• Technical and application support
• Annual software maintenance and support agreements
• QSI validation services

Notable Customers

• Xytex Cryo International: Reported that TMS fit their budget, delivered amazing turnaround time, and significantly improved employee morale through its training capabilities.
• Langley Air Force Base (Acquisition Management and Integration Center): Used TMS to integrate all functions into one centralized system, automating processes end-to-end and providing a seamless repository for internal and external audits.
• The IR-4 Project: Reduced processes that previously took three to five days to completion that now happens immediately with instantaneous results.

With a diverse client base of single and multi-site companies and a long track record of customer relationships dating back to 1992, TMS Quality Compliance Software continues to deliver cost-effective, compliance-ready solutions that free quality and regulatory teams from administrative chaos and position organizations for growth.