Quality Connect is cloud-based quality management system (QMS) software designed for life sciences organizations to manage document control, training, quality events, CAPA, and change control. The system automates quality workflows while providing real-time visibility into compliance status. Core capabilities: - Document Control: Real-time collaborative authoring in Microsoft Word, configurable review and approval workflows, electronic signatures compliant with 21 CFR Part 11 and Annex 11, automatic versioning with PDF conversion, and document template center - Training Management: Role-based training matrix with automatic assignment, system-generated gap identification and remediation reports, online quizzes, centralized e-learning content, and training tracking for external employees - Quality Events & CAPA: Intelligent event capture with adaptive forms, automated investigation workflows, action tracking through closure, root cause analysis support, and real-time KPI dashboards - Change Control: Centralized change planning with structured workflows, automated routing and notifications, change rationale tracking with audit trails, and configurable reporting - Inspector Area: Dedicated space to copy quality records for regulator and auditor review Compliance: 21 CFR Part 11 and EudraLex Annex 11 compliant, ISO 9001:2015 aligned, hosted on Microsoft Azure with SOC 2 Type I certification, GDPR compliant. Problems solved: Small-to-mid-sized life sciences organizations transitioning from manual, paper-based, Excel, or SharePoint quality systems face audit readiness anxiety from lack of real-time compliance visibility, administrative overhead from chasing signatures and training acknowledgments, version control chaos with uncertainty about current SOP versions, training compliance gaps with inability to quickly identify overdue requirements, and manual CAPA tracking that creates compliance risk. Value delivered: - Audit readiness: System-generated reports provide instant compliance status without manual compilation - Operational efficiency: Automated workflows reduce administrative tasks, freeing QA teams for strategic work - Automated compliance: Role-based training matrices automatically assign requirements and identify gaps in real-time - Rapid implementation: 4-8 week implementation with included validation package - Scalability: Automated processes support growth without proportional QA team expansion - Cost-effective: Right-sized for growing companies without enterprise complexity Target users: QA/RA Directors, Quality Managers, Regulatory Affairs professionals, Clinical Operations Managers, and Compliance teams at biotech, pharma, and medical device companies preparing for FDA/EMA inspections or client audits.