- Overview
- See the most important activity across your quality system in one place - including document reviews, approvals, periodic reviews, training due and recent work. The Overview gives both quality leaders and individual users a practical starting point for the day. It helps teams understand priorities quickly, identify overdue or blocked activities and move directly into the records that need attention without checking multiple areas of the system. Key capabilities: Reviews & approvals, Periodic review status, Training due, Direct access to records.
- My Tasks
- Give every user one clear workspace for the reviews, approvals, training assignments and quality actions that belong to them. My Tasks makes ownership visible and helps reduce missed actions, reminder emails and manual follow-up. Users can see what is due, what is waiting and what should be completed next, while quality teams gain clearer accountability across the QMS. Key capabilities: Assigned actions, Due-date visibility, Direct record access, Clear ownership.
- Document Control
- Manage SOPs, policies, work instructions, forms and other controlled documents through their full lifecycle - from drafting and review to approval, release and periodic review. Effective document control is essential for making sure teams always work from the correct approved version. It also gives auditors and regulators a clear record of changes, review history, approvals and document status, reducing the risk of outdated or uncontrolled information being used. Key capabilities: Version control, Review & approval, Periodic review, Audit-ready history.
- Quality Processes
- Manage nonconformities, CAPA, deviations, change control, complaints and investigations through structured, traceable workflows. Quality events need consistent handling, clear ownership and documented evidence. This module helps teams capture issues, investigate causes, assign actions, follow progress and close records in a controlled way - while creating better inputs for audits, management review and continuous improvement. Key capabilities: NC & deviations, CAPA, Change control, Complaints & investigations.
- Training
- Connect required training with the controlled documents, processes and responsibilities that employees need to understand. Training records are a core part of demonstrating employee competence and QMS awareness. QraOne helps teams assign training, monitor completion and overdue items and retain evidence in one place, making it easier to show that the right people have been trained on current procedures. Key capabilities: Training assignment, Completion tracking, Due-date monitoring, Training records.
- Suppliers
- Centralise supplier qualification, approvals, documentation, periodic reviews and ongoing supplier performance information. External suppliers can directly affect product quality and regulatory compliance. This module helps teams maintain evidence of supplier selection and monitoring, identify higher-risk suppliers and keep qualification and review activities organised instead of spread across spreadsheets and shared folders. Key capabilities: Supplier qualification, Approval status, Periodic review, Performance records.
- Design Control
- Connect design inputs, outputs, risks, verification, validation and supporting evidence throughout the product development lifecycle. Design Control helps quality, regulatory and engineering teams maintain traceability from what the product must do through to the evidence showing that requirements were met. This supports stronger design history, controlled product changes and better preparation for audits and regulatory submissions. Key capabilities: Design inputs & outputs, Risk links, V&V evidence, Lifecycle traceability.
- QraOne AI
- Use AI assistance for drafting, search, summarisation, gap identification and finding links across quality and regulatory information. QraOne AI is designed to reduce repetitive work and help teams find relevant information faster without replacing professional judgement. Suggestions remain subject to human review and approval, keeping qualified users in control while improving efficiency across documentation and quality workflows. Key capabilities: Drafting support, Gap identification, QMS search & summaries, Human review retained.
- QMS Statistics
- Turn quality-system activity into trends, workload indicators and management-level insights across documents, training and quality processes. QMS Statistics will help teams move beyond individual records and understand what the overall system is showing over time. It is intended to support trend monitoring, management review preparation, prioritisation and earlier identification of recurring issues or areas requiring attention. Key capabilities: Quality trends, Workload visibility, Performance indicators, Management review support.
eQMS