- 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>
15266e99f2