Alireza Rezvani 15266e99f2 fix(skill): rewrite quality-documentation-manager with document control content (#80) (#155) ...

- Remove placeholder files (example.py, api_reference.md, example_asset.txt)
- Add 12 trigger phrases for skill discoverability
- Add Table of Contents for navigation
- Remove marketing language ("comprehensive", "robust", "seamless", "expert-level")
- Create 5 numbered workflows with validation checkpoints:
  - Document Control Workflow with lifecycle stages
  - Document Numbering System with format and category codes
  - Approval and Review Process with comment disposition
  - Change Control Process with classification criteria
  - 21 CFR Part 11 Compliance with electronic controls
- Create document-control-procedures.md (~400 lines):
  - Document numbering format and workflow
  - Lifecycle stages and transitions
  - Review and approval matrix
  - Change control classification and impact assessment
  - Distribution methods and access control
  - Record retention periods and disposal
- Create 21cfr11-compliance-guide.md (~450 lines):
  - Part 11 scope and applicability
  - Electronic record requirements (§11.10)
  - Electronic signature requirements with manifestation
  - System controls (administrative, operational, technical)
  - Validation approach and documentation
  - Compliance checklist and gap assessment template
- Create document_validator.py (~450 lines):
  - Document numbering convention validation
  - Status and lifecycle validation
  - Date validation (effective, review due)
  - Approval requirements checking
  - Change history completeness
  - 21 CFR Part 11 controls validation
  - Interactive mode and JSON output

SKILL.md reduced from 266 to 438 lines with actionable workflows.

Co-authored-by: Claude Opus 4.5 <noreply@anthropic.com>

2026-01-30 17:54:40 +01:00

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