TraxQM is a risk-based Quality Management System (QMS) designed to help businesses proactively manage regulatory compliance and risk management. Developed by Codesplice Ltd, an ISO 9001 accredited company, TraxQM offers a comprehensive platform to streamline quality processes and ensure adherence to current regulatory requirements. Key Features: Document Manager: Supports Microsoft Office files with automated version control, 21 CFR Part 11 compliant electronic signatures via DocuSign, and a complete audit trail, ensuring data integrity in line with ALCOA principles. Offline sync support via OneDrive. Risk Analysis: Utilises ICH Q9 & FMEA Risk Management methodology to formalise a risk-based approach, helping businesses address potential deficiencies and anticipate inspectors' requirements. Event Manager: Enables the raising and risk assessment of complaints and deviations, implementing seven stages of Corrective and Preventive Actions (CAPA) using industry best practices. Change Control: Manages changes with impact and risk analysis, classification, and committee reviews, including verification and validation actions to ensure effective risk re-evaluation. Training Module: Offers over 600 ready-made courses and the ability to upload existing materials, with features for managing and measuring training programs, automatic course assignments, and access to staff training reports. Audit Management: Enhances audit processes with comprehensive features designed to ensure thorough compliance and continuous improvement, supporting both internal and external audits. Management Module: Provides a robust set of tools to help organisations manage their structures, assets, and strategic plans effectively via Organogram, Assets register, automatic suppliers & pharmacy validation. AI Integration: TraxQM is integrated with AI specially trained on GMP & GDP guidelines. The system assist you to review your documents, risks, KPIs and root cause analysis. Task Management: Provides Kanban boards for managing actionable and targeted work instructions, allowing users to specify assignees, priorities, time frames, and add comments and attachments. Forms Module: Easily create and customise dynamic forms using our integrated SurveyJS feature. Design tailored questionnaires, capture structured responses, and streamline data collection—all within TraxQM’s intuitive interface. Dashboard: Offers powerful data visualisation tools that provide a comprehensive overview of an organisation's quality health, empowering management with actionable insights and real-time data to drive informed decision-making and maintain regulatory compliance.