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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 when working on document control procedures, change control workflows, document numbering, version management, electronic signature compliance, or regulatory documentation review.

71

Quality

89%

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SecuritybySnyk

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SKILL.md
Quality
Evals
Security

Quality

Content

88%Weight 40%Scale 1-5

Reviews the quality of instructions and guidance provided to agents. Good implementation is clear, handles edge cases, and produces reliable results.

The body is a well-engineered, information-dense skill: concrete domain rules, executable script usage with a complete sample input, and workflows that each carry an explicit validation checkpoint. Remaining gaps are small — one bundled script is undocumented in SKILL.md, the TOC is missing two sections, and a couple of reference tables could migrate to the reference files.

DimensionReasoningScore

Conciseness

The body is dense and table-driven with essentially no conceptual padding — it teaches company-specific conventions (numbering, reviewer matrices, classification rules) Claude cannot know, matching the efficient anchor at 4. A few sections (Document Control Metrics, Regulatory Requirements tables) sit at the edge of what belongs in a reference file, keeping it below the every-token-earns-its-place anchor at 5; the time-sensitive QMSR material is acceptably framed as a legacy/status callout.

4 / 5

Actionability

Guidance is fully executable: copy-paste commands for the validator ("python scripts/document_validator.py --doc document.json", "--output json", "--sample"), a complete sample document JSON, and concrete rule tables (numbering format "PREFIX-CATEGORY-SEQUENCE[-REVISION]", change classification, approval matrices) that cover the common cases, matching the top anchor.

5 / 5

Workflow Clarity

Every workflow (document control, numbering, review, change control, Part 11 controls) is a numbered sequence ending in a bolded explicit "**Validation:**" checkpoint, with checklists (System Controls, Impact Assessment) and a comment-address/resubmit loop — matching the anchor requiring explicit validation steps, feedback loops, and checklists; it is well above the most-checkpoints-present anchor at 4.

5 / 5

Progressive Disclosure

Structure is good: two real one-level-deep references ("references/document-control-procedures.md", "references/21cfr11-compliance-guide.md") are clearly signaled with bullet summaries of their contents, and the validator script has inline usage. It falls short of the top anchor because "scripts/document_version_control.py" exists in the bundle but is never mentioned in the body, and the Table of Contents omits the Document Control Metrics and Regulatory Requirements sections.

4 / 5

Total

18

/

20

Passed

Description

87%Weight 40%Scale 1-5

Based on the skill's description, can an agent find and select it at the right time? Clear, specific descriptions lead to better discovery.

A strong description: it states a concrete domain (medical device QMS document control), enumerates its capability areas, and closes with an explicit "Use when..." clause carrying six natural trigger phrases. The only minor gap is that a few natural synonyms (audit trail, SOP, document approval) live in metadata triggers rather than the description text itself.

DimensionReasoningScore

Specificity

The description lists several concrete capability areas — "document numbering, version control, change management, and 21 CFR Part 11 compliance" — but frames them as topics it "Covers" rather than naming the actions performed, leaving it just short of the comprehensive concrete-actions anchor at 5 and clearly above the 1-2-action anchor at 3.

4 / 5

Completeness

It explicitly answers both questions: "Document control system management for medical device QMS. Covers..." states the what, and "Use when working on document control procedures, change control workflows..." gives concrete trigger phrases for the when, exactly matching the top anchor; the level-4 anchor (when only loosely specified) clearly undersells it.

5 / 5

Trigger Term Quality

"document control procedures, change control workflows, document numbering, version management, electronic signature compliance, or regulatory documentation review" are natural phrases a QMS user would say, matching the good-coverage anchor; it misses a few common variations (e.g., "audit trail", "SOP", "document approval") that appear only in the metadata triggers, so not the comprehensive-synonyms anchor at 5.

4 / 5

Distinctiveness Conflict Risk

The medical device QMS niche with "21 CFR Part 11 compliance" and "electronic signature compliance" forms a clear domain with distinct triggers and minimal overlap risk against generic documentation skills, matching the clear-niche anchor at 5.

5 / 5

Total

18

/

20

Passed

Validation

87%

Checks the skill against the spec for correct structure and formatting. All validation checks must pass before discovery and implementation can be scored.

Validation — 14 / 16 Passed

Validation for skill structure

CriteriaDescriptionResult

metadata_version

'metadata.version' is missing

Warning

metadata_field

'metadata' should map string keys to string values

Warning

Total

14

/

16

Passed

Repository

alirezarezvani/claude-skills

Path

ra-qm-team/skills/quality-documentation-manager/SKILL.md

Reviewed

Table of Contents

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