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Michael Lehotay edited this page Sep 27, 2025
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Welcome to the Red Witch Wiki, your central hub for documentation, quality management, project planning, and operational guidance for the Red Witch project at Floating Eye Software (FLEY).
This wiki organizes all key information for team members, auditors, and stakeholders, including SOPs, Work Instructions (WIs), project plans, templates, and records.
Learn about Red Witch’s commitment to quality, compliance, and continuous improvement.
- Quality Manual – Comprehensive overview of FLEY’s Quality Management System (QMS).
- Document Control SOP – Standard Operating Procedure for managing controlled documents.
- Quality Planning SOP – Guidance for creating and maintaining quality plans.
- Work Instructions Overview – Step-by-step guidance for implementing SOPs and project workflows.
Resources for planning and executing Red Witch projects effectively.
- Red Witch Quality Plan – Project-specific quality plan for Red Witch.
- Pilot SOP Plan – Pilot plan for drafting and testing SOPs.
- Continuous Improvement Plan – Organization-wide plan for maturity and compliance reviews.
- Project Quality Plan Template – Template for creating new project-level quality plans.
- Quality Plan Template – Template for general quality plans.
Information and tools to maintain regulatory compliance and traceability.
- Audit & CAPA Records – Repository for CAPA logs, audit results, and related evidence.
- Regulatory Guidance – Overview of ISO 13485, ISO 9001, 21 CFR 820, GDPR.
- Governance & Review – Continuous improvement cycles, ISO 9004 self-assessments, and SOP updates.
- Infrastructure & Security – Access control, repository permissions, and secure workflow practices.
- Privacy & GDPR Compliance – Policies and procedures for protecting personal data.
- Design Control – Documentation and process guidance for design and development.
- Traceability & Verification – Mapping requirements, design outputs, and verification activities.
- Document Control – Maintaining controlled documents and versioning.
- README – Quick start guide for new team members.
- Drafts Overview – Draft SOPs, Work Instructions, and other in-progress documentation.
- Use the headings above to navigate by topic.
- Links within each page provide traceability to issues, milestones, and GitHub PRs.
- The Quality Manual is the best starting point for understanding FLEY’s QMS framework.