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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.

68

Quality

85%

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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

70%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 well organized with excellent validated workflows and concrete, actionable procedural guidance. Its main weaknesses are a broken bundle (all referenced reference files and the validator script are missing) and significant inlining/duplication of detail that belongs in the reference files, which inflates token cost.

Suggestions

Ship the referenced bundle files — references/document-control-procedures.md, references/21cfr11-compliance-guide.md, and scripts/document_validator.py — or remove the references; all three are cited in the body but absent from the bundle, so the validator commands and 'See ...' pointers currently fail.

De-duplicate the body against the reference files: move the full category-code table, Part 11 requirement/signature tables, and KPI metrics into the references and keep only the quick-reference essentials in SKILL.md.

Tighten sections not tied to the skill's triggers (e.g. Document Control Metrics and the basic Signature Requirements table) or move them to a reference to reduce body length.

DimensionReasoningScore

Conciseness

The ~420-line body is mostly dense tables rather than padded prose, but substantial detail is inlined that the body itself says belongs in the reference files — the numbering tables duplicate "complete numbering guidance" in references/document-control-procedures.md, and the 21 CFR Part 11 section (scope, record controls, audit trail, signature requirements) duplicates references/21cfr11-compliance-guide.md. Sections like KPI metrics and the basic Signature Requirements table (name, date, role) also restate content Claude already knows or that is tangential to the skill's triggers. This matches 'Mostly efficient but includes some unnecessary explanation or could be tightened' rather than the level-4 anchor's 'minor instances'.

3 / 5

Actionability

Concrete, executable guidance throughout: exact numbering format with a worked example ("SOP-02-001-A"), copy-paste tool commands with flags ("python scripts/document_validator.py --doc document.json --output json"), a complete sample input JSON, and specific matrices (reviewers, dispositions, change classification). Not a 5 because the advertised validator script cannot actually be run — scripts/document_validator.py is absent from the bundle — leaving the Tools section's commands non-executable as shipped; still more than the level-3 anchor's incomplete/pseudocode level since all procedural guidance is specific and complete.

4 / 5

Workflow Clarity

Every workflow (document control, numbering, review, change control, electronic record controls) is a clearly numbered sequence ending in an explicit bolded **Validation:** checkpoint (e.g. "Validation: Audit trail captures who, what, when for all changes"), with a feedback loop in the review workflow ("Author resubmits revised document") and checklists for complex processes (System Controls Checklist, Impact Assessment). This matches the anchor-5 example pattern of numbered steps, explicit validation, and error-recovery loops.

5 / 5

Progressive Disclosure

References are clearly signaled one level deep ("See references/document-control-procedures.md for complete numbering guidance" plus a Reference Documentation section describing each file's contents), but the actual bundle contains no references/, scripts/, or assets/ directories — all three referenced paths (two reference docs, one script) are dangling. Additionally, detail that should live in those files (category code tables, Part 11 requirements, metrics) is inlined in the body. This matches 'Some structure but could be better organized' rather than level 4, whose 'references mostly clear' presumes the referenced files actually exist; better than level 2 because structure and signaling in the body itself are good.

3 / 5

Total

15

/

20

Passed

Description

96%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, well-structured description: explicit third-person capability statement plus a concrete 'Use when...' clause with natural trigger phrases. The only weakness is mild overlap risk from generic terms like 'version control' (commonly meaning git) and 'regulatory documentation review'.

DimensionReasoningScore

Specificity

"Covers document numbering, version control, change management, and 21 CFR Part 11 compliance" enumerates multiple concrete capabilities of the skill in third-person voice ("Covers", "Use when working on"), comparable to the anchor example 'Extract text and tables from PDF files, fill forms, merge documents'. Not a 4: the enumerated capabilities span the domain's core functions comprehensively with no significant coverage gaps.

5 / 5

Completeness

Explicitly answers both questions: what — "Document control system management for medical device QMS. Covers document numbering, version control, change management, and 21 CFR Part 11 compliance"; when — "Use when working on document control procedures, change control workflows, ... or regulatory documentation review". Matches the anchor's good example structure of concrete what + concrete 'Use when...' trigger phrases, so not a 4.

5 / 5

Trigger Term Quality

"document control procedures, change control workflows, document numbering, version management, electronic signature compliance, or regulatory documentation review" are exactly the natural phrases a QMS professional would say, with synonym variation (version control / version management). Not a 4: keyword coverage is comprehensive including synonyms, matching the 'PDF files, PDFs, forms, document extraction, .pdf' anchor's breadth (no file extensions exist in this domain to include).

5 / 5

Distinctiveness Conflict Risk

The medical-device QMS niche with "21 CFR Part 11" and "change control" triggers is a clear niche, but "version control" is a term users most often use for git, and "regulatory documentation review" could overlap broader regulatory-affairs skills — minor overlap risk, matching the anchor 'Mostly distinct; minor overlap risk with closely related skills'. Not a 5 because of these ambiguous generic terms; not a 3 because the domain scoping ('for medical device QMS') keeps conflicts unlikely.

4 / 5

Total

19

/

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

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

Path

.gemini/skills/quality-documentation-manager/SKILL.md

Reviewed

Table of Contents

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