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Quality Documentation Manager
作者
Alireza Rezvani
· GitHub ↗
· v2.1.1
· MIT-0
3515
总下载
2
收藏
24
当前安装
3
版本数
在 OpenClaw 中安装
/install quality-documentation-manager
功能描述
Document control system management for medical device QMS. Covers document numbering, version control, change management, and 21 CFR Part 11 compliance. Use...
安全使用建议
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.
功能分析
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.
能力评估
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.
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.
如何使用
- 确保已安装 OpenClaw（本地或 Docker 部署）
- 在对话框中输入安装命令：
/install quality-documentation-manager - 安装完成后，直接呼叫该 Skill 的名称或使用
/quality-documentation-manager触发 - 根据 Skill 的参数说明提供必要输入，即可获得结构化输出
版本历史
v2.1.1
v2.1.1: optimization, reference splits
v1.0.0
Initial release.
- Provides comprehensive document control management for medical device QMS, including numbering, versioning, and change management.
- Supports ISO 13485 compliance and integrates 21 CFR Part 11 electronic record/signature requirements.
- Includes detailed workflows for document creation, review, approval, distribution, and obsolescence.
- Offers standardized templates for document numbering, lifecycle, reviewer assignment, and revision tracking.
- Enables systematic change control with impact assessment and robust audit trails.
v0.1.0
Initial release — quality documentation management for medical device QMS.
- Supports document numbering, version control, change management, and approval workflows.
- Ensures compliance with 21 CFR Part 11 for electronic records and signatures.
- Includes templates and procedures for document lifecycle, review, and audit trail.
- Provides guidance on document types, required reviewers, and revision control.
- Designed for ISO 13485-compliant document control systems.
元数据
常见问题
Quality Documentation Manager 是什么？
Document control system management for medical device QMS. Covers document numbering, version control, change management, and 21 CFR Part 11 compliance. Use... 它是一个面向 Claude Code / OpenClaw 的 AI Agent Skill 插件，目前累计下载 3515 次。
如何安装 Quality Documentation Manager？
在 OpenClaw 或 Claude Code 对话框中运行命令「/install quality-documentation-manager」即可一键安装，无需额外配置。
Quality Documentation Manager 是免费的吗？
是的，Quality Documentation Manager 完全免费，采用 MIT-0 许可证，可自由下载、安装和使用。
Quality Documentation Manager 支持哪些平台？
Quality Documentation Manager 跨平台运行，可在任意部署了 OpenClaw / Claude Code 的环境中使用（cross-platform）。
谁开发了 Quality Documentation Manager？
由 Alireza Rezvani（@alirezarezvani）开发并维护，当前版本 v2.1.1。
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