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Red Witch Wiki

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, project plans, templates, and records.

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1. Quality Management

Learn about Red Witch’s commitment to quality, compliance, and continuous improvement.

• Quality Manual – Comprehensive overview of FLEY’s Quality Management System (QMS).

• SOPs – Standard Operating Procedures, including:

  • Document Control SOP
  • Quality Planning SOP

• Work Instructions (WIs) – Step-by-step guidance for implementing SOPs in GitHub and project workflows.

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2. Project Planning & Execution

Resources for planning and executing Red Witch projects effectively.

• Project Documentation – Project-specific quality plans and related artifacts.

  • Red Witch Quality Plan

• Plans – Templates and pilot plans for continuous improvement:

  • Pilot SOP Plan
  • Continuous Improvement Plan

• Templates – Predefined templates for project quality plans, SOPs, and records.

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3. Compliance & Governance

Information and tools to maintain regulatory compliance and traceability.

• Audit & CAPA Records – Repository for CAPA logs, audit results, and related evidence.
• Regulatory Guidance – ISO 13485, ISO 9001, 21 CFR 820, GDPR.
• Governance & Review – Continuous improvement, ISO 9004 self-assessments, and SOP updates.

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4. Information Security & Access

• Infrastructure & Security – Access control, repository permissions, and secure workflow practices.
• Privacy & GDPR Compliance – Policies and procedures for protecting personal data.

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5. Design & Development

• 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 ensuring proper versioning.

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6. Getting Started

• README – Quick start guide for new team members.
• Drafts – Draft SOPs, work instructions, and other in-progress documentation.

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Navigation Tips

• Use the folders on the left to browse by category (SOPs, WIs, Plans, Project-Docs, Templates, Records).
• Links within each document provide traceability to issues, milestones, and GitHub PRs.
• Check the Quality Manual for overarching guidance on FLEY’s QMS.