ClawHub

Quality Documentation Manager

v2.1.1

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

⭐ 2· 3.4k·23 current·23 all-time
byAlireza Rezvani@alirezarezvani
MIT-0
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LicenseMIT-0 · Free to use, modify, and redistribute. No attribution required.
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high confidence
✓
Purpose & Capability
Name and description (document control, 21 CFR Part 11, numbering, approvals) align with the included materials: a long SKILL.md, two reference documents on procedures/compliance, and a document_validator.py script that checks numbering, dates, statuses, and electronic controls. Nothing in the manifest (no binaries, no env vars, no config paths) is out of scope for a documentation manager.
✓
Instruction Scope
SKILL.md contains procedural guidance and workflows limited to document control, numbering, approval, change control, and Part 11 coverage. It references only the included reference files and does not instruct reading unrelated system files, environment variables, or sending data externally. The instructions are specific to QMS tasks rather than open-ended data collection.
✓
Install Mechanism
There is no install spec (instruction-only skill) and no downloads. A single Python script is present that appears to be a local validator using standard library modules. No external package installs or remote URLs are used.
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Credentials
The skill declares no required environment variables, no credentials, and no config paths. The included validator script operates on provided document JSON or interactive input and uses only standard libraries—proportionate for a document validation utility.
✓
Persistence & Privilege
always:false (default) and the skill does not request system-wide configuration changes or access to other skills' credentials. Autonomous invocation is permitted by platform default but is not combined here with elevated privileges or broad credential access.
Assessment
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.

Like a lobster shell, security has layers — review code before you run it.

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License

MIT-0
Free to use, modify, and redistribute. No attribution required.
Termshttps://spdx.org/licenses/MIT-0.html

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