Quality Documentation Manager

Document control system management for medical device QMS. Covers document numbering, version control, change management, and 21 CFR Part 11 compliance. Use...

This skill appears internally consistent and focused on QMS document control. Before installing, review the full document_validator.py file to confirm there are no hidden network calls or logging of sensitive content (the visible code uses only stdlib and local validation). Because the skill's source and homepage are unknown, consider running it in an isolated environment and do not supply real patient or production records until you verify its behavior. If you plan to integrate it with a live DMS, confirm it meets your organization's security, traceability, and Part 11 technical controls (audit trail storage, signature linking, access control) and that its validation rules match your SOPs.

Type: OpenClaw Skill Name: quality-documentation-manager Version: 2.1.1 The skill bundle provides a legitimate framework for managing medical device quality documentation according to ISO 13485 and 21 CFR Part 11 standards. The included Python script (scripts/document_validator.py) performs static metadata validation using standard libraries without any network access, file system modifications, or suspicious execution patterns. No evidence of prompt injection, data exfiltration, or malicious intent was found in the documentation or code.