alt-QMS

Scispot alt-QMS is a modern, AI-powered Quality Management System designed specifically for biotech, pharmaceutical, diagnostics, and other laboratory-based life sciences companies. Built with an intuitive, user-friendly interface and a scalable architecture, alt-QMS transforms regulatory compliance from a reactive burden into a streamlined, proactive process—enabling lab teams to spend more time on science and less on paperwork.

alt-QMS is purpose-built to meet the compliance demands of regulated lab environments, supporting standards including GxP, FDA 21 CFR Part 11, ISO 17025, CLIA, and GMP. It is available as a standalone solution or as part of Scispot's fully integrated Lab Operating System (LabOS), which also includes alt-LIMS, alt-ELN, and GLUE.

Document Control

• Centralize and securely manage critical documents including SOPs, protocols, procedures, and compliance records.
• Smart automated version control ensures documents are always current and traceable.
• Intuitive approval workflows and user-friendly acknowledgment tracking simplify document sign-off processes.
• AI-driven reminders proactively flag upcoming review or compliance deadlines.

Training Management

• Link staff training records directly to relevant documents and SOPs for seamless traceability.
• Automatically monitor real-time training statuses across the organization.
• AI-assisted alerts notify managers and staff of upcoming or overdue training sessions.
• Intuitive management dashboards provide a clear overview of team compliance status at all times.

Change Control

• Highly configurable, no-code workflows enable labs to manage changes across processes and operations without IT dependency.
• Detailed tracking, smart reminders, and comprehensive reporting cover every change initiative from initiation to closure.
• Transparent and adaptable workflows are designed to evolve alongside changing lab needs.

Audit Trails and Electronic Signatures

• Comprehensive audit logs capture every action with timestamps and full traceability.
• Secure electronic signatures fully comply with regulatory standards, including FDA 21 CFR Part 11.
• Simplified demonstration of data integrity and regulatory compliance during internal and external audits.

Regulatory Compliance Support

• Engineered to meet pharmaceutical and life sciences compliance requirements including GxP, FDA 21 CFR Part 11, ISO 17025, and CLIA.
• Built-in regulatory checklists provide proactive compliance guidance throughout daily operations.
• Automated compliance tracking accelerates audit preparedness and reduces last-minute scrambles.

Key Platform Advantages

• Unified Platform: Seamlessly integrates quality management with daily lab operations when bundled with other Scispot applications such as alt-LIMS, alt-ELN, and GLUE.
• Enhanced Efficiency: AI-driven automation significantly reduces manual tasks, administrative overhead, and the risk of human error.
• Advanced Compliance: Proactive, intelligent compliance features that go beyond the capabilities of traditional QMS systems.
• White Glove Support: Personalized setup assistance combined with unlimited expert training and consulting to ensure successful adoption.

Integrations and Deployment

• API-first architecture enables seamless integration with over 100 lab instruments, existing ELNs, LIMS, and other operational software tools.
• Quality data is automatically linked to lab workflows, eliminating manual data entry and reducing errors.
• Designed to fit into existing lab environments without disruption, ensuring comprehensive quality management from day one.

Scispot alt-QMS is suitable for a broad range of life sciences sectors including drug discovery, contract testing labs, molecular diagnostics, pathology, biobanking, industrial biotech, and pharma and clinical QC labs. Its flexible, no-code configuration and modern design make it an ideal alternative to rigid, legacy QMS platforms for forward-thinking laboratory organizations.