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Welcome to the Red Witch Wiki, the central hub for documentation, quality management, project planning, compliance, and operational guidance for Floating Eye Software (FLEY) and the Red Witch pilot project.
This wiki organizes all key information for team members, auditors, and stakeholders, including:
- QMS authoring and operations (SOPs, WIs, policies, quality manual)
- Project documentation for Red Witch
- Compliance standards and frameworks
- Templates, plans, and operational guidance
Use this page as your starting point to navigate QMS, Red Witch, and organizational resources.
FLEY is committed to quality, compliance, and continuous improvement.
Key QMS Documentation:
- Quality Manual – Comprehensive overview of FLEY’s QMS framework.
- Quality Policy – Organizational quality policy and objectives.
- QMS Process Map – Visual representation of workflows and interactions.
- Context – Organizational context, risk considerations, and interested parties.
- Org Chart – Roles, responsibilities, and accountabilities for QMS operations.
- Risk Register – Active and historical risks with mitigation actions.
SOPs & WIs:
- Document Control SOP
- Change Control SOP
- Design Control SOP
- Project Management SOP
- Leadership SOP
- Quality Planning SOP
- Risk and Opportunity Management SOP
- Work Instructions: GitHub QMS Operations, GitHub QMS Setup, FLEY Design Control WI, Information Security WI, Ontario Design Framework WI
Templates:
- Standard Operating Procedure Template
- Quality Plan Template
- Project Quality Plan Template
- Design Control Plan Template
- Design Output Template
Tip: Start with the Quality Manual to understand the overall QMS structure and workflows.
Centralized documentation for the Red Witch pilot project.
- Red Witch Master Document List – Index linking all Red Witch documents.
- Red Witch Quality Plan – Project-specific quality plan.
- Red Witch Privacy – Privacy considerations.
- Red Witch Accessibility – Accessibility requirements.
- Red Witch Users – User analysis and personas.
- Red Witch Requirements – Functional and non-functional requirements.
- Red Witch Roadmap – Development roadmap and milestones.
- Red Witch Risk Management – Risk analysis and mitigation.
- Red Witch Post-Market Surveillance – Post-market monitoring and reporting.
- Red Witch Software Architecture – Technical architecture overview.
- Red Witch Market Analysis – Market research documentation.
- Red Witch Market Comparison – Comparative research insights.
- Red Witch Peer Review – More comparative research insights.
Resources for planning, execution, and organization-wide improvement.
- Continuous Improvement Plan – Framework for monitoring and improving QMS maturity.
- Red Witch Pilot SOP Plan – SOP authoring and pilot testing.
- Project and quality plan templates: Project Quality Plan Template, Quality Plan Template
Tip: Track all QMS operations issues in the FLEY QMS Kanban board, including SOP/WI authoring, risk management, objectives, CAPA, and audits.
Reference documents for internal and external compliance requirements.
- Compliance Index – Overview of all compliance frameworks tracked.
- 21 CFR 820 – FDA QSR for medical devices.
- ISO 13485 – Medical device quality management standard.
- ISO 14971 – Risk management for medical devices.
- ISO 9001 – International quality management system standard.
- IEC 62304 – Medical device software lifecycle processes.
- Ontario DSS – Ontario Digital Service Standard compliance.
- Use the headings above to find QMS, Red Witch, or compliance content quickly.
- Issue, PR, and board links provide traceability from SOPs/WIs to QMS operations.
- Use labels and links to track dependencies between QMS authoring, operations, and product validation.
- Start with Quality Manual to understand the FLEY QMS structure.
- Red Witch-specific issues should reference QMS SOP/WI Issues where validation is required.