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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.

67

Quality

82%

Does it follow best practices?

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Adds up to 20 points to the overall score

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SecuritybySnyk

Passed

No findings from the security scan

The canonical home for this skill is quality-documentation-manager in alirezarezvani/claude-skills

SKILL.md
Quality
Evals
Security

Quality

Content

77%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.

A well-structured, action-oriented reference skill with excellent validated workflows and concrete tooling, undermined by progressive-disclosure defects: the referenced bundle files are absent and detail that should live in those files is inlined in the main body.

Suggestions

Create the missing bundle files referenced in the body (references/document-control-procedures.md, references/21cfr11-compliance-guide.md, scripts/document_validator.py) so the signaled navigation actually resolves.

Move the large reference tables that belong in the procedures guide (full category-code list, KPI table, regulatory clause mapping) into references/document-control-procedures.md, keeping SKILL.md a concise overview.

Tighten the QMSR transition warning (lines 419-429) to the essential citation guidance so the regulatory section stays token-efficient.

DimensionReasoningScore

Conciseness

The body is lean and table-driven with reference data Claude would not know (category codes, reviewer matrices, KPI targets), avoiding concept re-explanation; the QMSR transition warning block is the main instance of over-explanation that could be trimmed.

4 / 5

Actionability

Concrete, copy-pasteable validator commands ('python scripts/document_validator.py --doc document.json --output json') and a complete sample JSON input cover common cases, though much of the guidance is procedural/declarative reference rather than executable code.

4 / 5

Workflow Clarity

Every workflow (Document Control, Numbering, Review, Change Control, Electronic Record Controls) is a numbered sequence ending in an explicit bolded '**Validation:**' checkpoint, with checklists for impact assessment and system controls — matching the anchor-5 pattern including validation for batch/approval operations.

5 / 5

Progressive Disclosure

Structure is good (Table of Contents, clear sections, one-level-deep signaled references to references/*.md and scripts/*.py), but those bundle files do not exist and large reference-grade tables are inlined in SKILL.md, leaving navigation broken and content that belongs in the references inline.

3 / 5

Total

16

/

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, third-person description that states a precise niche and pairs a clear capability list with an explicit, keyword-rich 'Use when' clause. The only soft spot is specificity/trigger coverage, which is comprehensive but not maximally exhaustive.

DimensionReasoningScore

Specificity

Names the domain ('document control system management for medical device QMS') and lists several specific capabilities — 'document numbering, version control, change management, and 21 CFR Part 11 compliance' — with only minor gaps versus the comprehensive anchor.

4 / 5

Completeness

It clearly answers both 'what' (document control system management covering the four areas) and 'when' ('Use when working on document control procedures, change control workflows...') with concrete trigger phrases, matching the anchor-5 pattern.

5 / 5

Trigger Term Quality

The 'Use when' clause supplies good natural keywords ('document control procedures, change control workflows, document numbering, version management, electronic signature compliance, or regulatory documentation review') with synonym pairs, though a few natural variations are absent.

4 / 5

Distinctiveness Conflict Risk

The medical-device QMS / 21 CFR Part 11 niche is highly specific with distinct triggers, making conflict with unrelated skills unlikely.

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.

Validation14 / 16 Passed

Validation for skill structure

CriteriaDescriptionResult

frontmatter_unknown_keys

Unknown frontmatter key(s) found; consider removing or moving to metadata

Warning

referenced_paths_exist

Referenced path issues: 8 missing

Warning

Total

14

/

16

Passed

Repository
alirezarezvani/claude-skills
Reviewed

Table of Contents

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