Agent skill

Quality Documentation Manager

by alirezarezvani in alirezarezvani/claude-skills

Document control system management for medical device QMS. An agent skill from alirezarezvani/claude-skills.

MITAuto-check passedDevelopment

Install Quality Documentation Manager

skills CLI
$ npx skills add alirezarezvani/claude-skills --skill quality-documentation-manager -a claude-code

Project install by default; add -g for ~/.claude/skills/.

GitHub CLI
$ gh skill install alirezarezvani/claude-skills quality-documentation-manager --agent claude-code

Project scope by default; add --scope user for a personal install. Needs GitHub CLI 2.90.0 or later (public preview).

Manual copy
$ git clone --depth 1 https://github.com/alirezarezvani/claude-skills.git skills-src && mkdir -p .claude/skills && cp -r skills-src/ra-qm-team/skills/quality-documentation-manager .claude/skills/quality-documentation-manager && rm -rf skills-src

Use ~/.claude/skills/ instead of .claude/skills for a personal install. The folder must contain SKILL.md.

Claude Code skills documentation · loads skills from .claude/skills/

Facts

Skill name
quality-documentation-manager
GitHub stars
28k
Used in
1 other repo
Token cost
~3.9k tokens
SKILL.md length
1,471 words
Files
5 (incl. scripts, references)
Skills in repo
342
Repo updated
First seen
Licence
MIT

At a glance

Document control system management for medical device QMS. An agent skill from alirezarezvani/claude-skills.

  • Works in 8 steps: Assign document number per numbering… → Create document using controlled template → Route for review to required reviewers → …
  • Working on document control procedures
  • SKILL.md covers Table of Contents, Document Control Workflow, Document Numbering System and Approval and Review Process, plus 3 more sections
  • Runs Python scripts from its folder; calls python

What it does

Quality Documentation Manager is an agent skill from alirezarezvani/claude-skills. 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.

Its SKILL.md is about 3.9k tokens, which your agent loads only when the skill is triggered. The skill folder holds 6 other files, including scripts and reference files (for example `references/21cfr11-compliance-guide.md`, `references/document-control-procedures.md` and `scripts/document_validator.py`).

It sits in Development, covering Git workflow. The repository describes itself as: 380 Claude Code skills & agent skills & plugins (30+ Agents, 70+ custom commands, 380+ skills, customizable references, scripts)for Claude Code, Codex, Gemini CLI, Cursor, and 8… The licence is MIT.

When your agent uses it

  • Working on document control procedures
  • Change control workflows
  • Document numbering
  • Version management

Example prompts

  • “/quality-documentation-manager”

Requirements

  • Python 3

Workflow steps

8 steps, taken from the first numbered list in SKILL.md.

  1. Assign document number per numbering procedure
  2. Create document using controlled template
  3. Route for review to required reviewers
  4. Address review comments and document responses
  5. Obtain required approval signatures
  6. Assign effective date and distribute
  7. Update Document Master List
  8. Validation: Document accessible at point of use; obsolete versions removed

What it can do on your machine

Read from SKILL.md and the folder at commit 19392f7. It shows what the files ask for, not the result of running them.

  • Tool permissions

    Pre-approves nothing: there is no allowed-tools line, so your agent's usual permission prompts apply.

    From allowed-tools in the SKILL.md frontmatter.

  • Runs code

    Ships 2 files in scripts/ (Python), which the agent can run.

    Shell commands in SKILL.md call:

    • python

    From the folder's file list and the shell code blocks in SKILL.md.

  • Network

    No URLs in SKILL.md.

    From URLs in SKILL.md, links to its own repository left out.

  • Credentials

    Names no API keys, tokens, secrets or passwords.

    From names ending in _API_KEY, _TOKEN, _SECRET, _KEY or _PASSWORD in SKILL.md.

Context cost

Quality Documentation Manager loads about 3.9k tokens when it runs, and up to ~10k if it reads all its reference files. Until then it costs about 92 tokens; SKILL.md has 1,471 words of instructions outside code blocks.

Always · name and description, kept in context so the agent knows when to use it
~92
When it runs · the whole SKILL.md, loaded when a task matches
~3.9k
With references · SKILL.md plus every file in references/, read only if the agent opens them
~10k

Estimates: characters ÷ 4, the usual rule of thumb; real counts depend on the model's tokenizer. Scripts and assets cost tokens only if the agent reads them.

Safety

Auto-check passed

The automated check found no risky patterns in SKILL.md.

Automated static check — not a guarantee. Review scripts before installing. It scans the text of SKILL.md for risky patterns (piping downloads into a shell, reading credential files, hidden Unicode, destructive commands); the scripts in this folder are not scanned.

SKILL.md

The full file from alirezarezvani/claude-skills at commit 19392f7, republished under its MIT licence (© alirezarezvani). 1,471 words, ~3,889 tokens.

Download SKILL.mdSave it as .claude/skills/quality-documentation-manager/SKILL.md (or your agent's skills folder). This skill also uses 4 other files; get the full folder from GitHub.
name
quality-documentation-manager
description
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.
triggers
document control, document numbering, version control, change control, document approval, electronic signature, 21 CFR Part 11, audit trail, document…

Quality Documentation Manager

Document control system design and management for ISO 13485-compliant quality management systems, including numbering conventions, approval workflows, change control, and electronic record compliance.


Table of Contents


Document Control Workflow

Implement document control from creation through obsolescence:

  1. Assign document number per numbering procedure
  2. Create document using controlled template
  3. Route for review to required reviewers
  4. Address review comments and document responses
  5. Obtain required approval signatures
  6. Assign effective date and distribute
  7. Update Document Master List
  8. Validation: Document accessible at point of use; obsolete versions removed
Document Lifecycle Stages
StageDefinitionActions Required
DraftUnder creation or revisionAuthor editing, not for use
ReviewCirculated for reviewReviewers provide feedback
ApprovedAll signatures obtainedReady for training/distribution
EffectiveTraining complete, releasedAvailable for use
SupersededReplaced by newer revisionRemove from active use
ObsoleteNo longer applicableArchive per retention schedule
Document Types and Prefixes
PrefixDocument TypeTypical Content
QMQuality ManualQMS overview, scope, policy
SOPStandard Operating ProcedureProcess-level procedures
WIWork InstructionTask-level step-by-step
TFTemplate/FormControlled forms
SPECSpecificationProduct/process specs
PLNPlanQuality/project plans
Required Reviewers by Document Type
Document TypeRequired ReviewersRequired Approvers
SOPProcess Owner, QAQA Manager, Process Owner
WIArea Supervisor, QAArea Manager
SPECEngineering, QAEngineering Manager, QA
TFProcess OwnerQA
Design DocumentsDesign Team, QADesign Control Authority

Document Numbering System

Assign consistent document numbers for identification and retrieval.

Numbering Format

Standard format: PREFIX-CATEGORY-SEQUENCE[-REVISION]

Example: SOP-02-001-A

SOP = Document type (Standard Operating Procedure)
02  = Category code (Document Control)
001 = Sequential number
A   = Revision indicator
Category Codes
CodeFunctional AreaDescription
01Quality ManagementQMS procedures, management review
02Document ControlThis area
03Human ResourcesTraining, competency
04Design & DevelopmentDesign control processes
05PurchasingSupplier management
06ProductionManufacturing procedures
07Quality ControlInspection, testing
08CAPACorrective/preventive actions
09Risk ManagementISO 14971 processes
10Regulatory AffairsSubmissions, compliance
Numbering Workflow
  1. Author requests document number from Document Control
  2. Document Control verifies category assignment
  3. Document Control assigns next available sequence number
  4. Number recorded in Document Master List
  5. Author creates document using assigned number
  6. Validation: Number format matches standard; no duplicates in Master List
Revision Designation
Change TypeRevision IncrementExample
Major revisionIncrement numberRev 01 → Rev 02
Minor revisionIncrement sub-revisionRev 01 → Rev 01.1
AdministrativeNo change or letter suffixRev 01 → Rev 01a

See references/document-control-procedures.md for complete numbering guidance.


Approval and Review Process

Obtain required reviews and approvals before document release.

Review Workflow
  1. Author completes document draft
  2. Author submits for review via routing form or DMS
  3. Reviewers assigned based on document type
  4. Reviewers provide comments within review period (5-10 business days)
  5. Author addresses comments and documents responses
  6. Author resubmits revised document
  7. Approvers sign and date
  8. Validation: All required reviewers completed; all comments addressed with documented disposition
Comment Disposition
DispositionAction Required
AcceptIncorporate comment as written
Accept with modificationIncorporate with changes, document rationale
RejectDo not incorporate, document justification
DeferAddress in future revision, document reason
Approval Matrix
Document Level 1 (Policy/QM): CEO or delegate + QA Manager
Document Level 2 (SOP): Department Manager + QA Manager
Document Level 3 (WI/TF): Area Supervisor + QA Representative
Signature Requirements
ElementRequirement
NamePrinted name of signer
SignatureHandwritten or electronic signature
DateDate signature applied
RoleFunction/role of signer

Change Control Process

Manage document changes systematically through review and approval.

Change Control Workflow
  1. Identify need for document change
  2. Complete Change Request Form with justification
  3. Document Control assigns change number and logs request
  4. Route to reviewers for impact assessment
  5. Obtain approvals based on change classification
  6. Author implements approved changes
  7. Update revision number and change history
  8. Validation: Changes match approved scope; change history complete
Change Classification
ClassDefinitionApproval LevelExamples
AdministrativeNo content impactDocument ControlTypos, formatting
MinorLimited content changeProcess Owner + QAClarifications
MajorSignificant content changeFull review cycleNew requirements
EmergencyUrgent safety/complianceExpedited + retrospectiveSafety issues
Impact Assessment Checklist
Impact AreaAssessment Questions
TrainingDoes change require retraining?
EquipmentDoes change affect equipment or systems?
ValidationDoes change require revalidation?
RegulatoryDoes change affect regulatory filings?
Other DocumentsWhich related documents need updating?
RecordsWhat records are affected?
Change History Documentation

Each document must include change history:

| Revision | Date | Description | Author | Approver |
|----------|------|-------------|--------|----------|
| 01 | 2023-01-15 | Initial release | J. Smith | M. Jones |
| 02 | 2024-03-01 | Updated workflow | J. Smith | M. Jones |

21 CFR Part 11 Compliance

Implement electronic record and signature controls for FDA compliance.

Part 11 Scope
Applies ToDoes Not Apply To
Records required by FDA regulationsPaper records
Records submitted to FDAInternal non-regulated documents
Electronic signatures on required recordsGeneral email communication
Electronic Record Controls
  1. Validate system for accuracy and reliability
  2. Implement secure audit trail for all changes
  3. Restrict system access to authorized individuals
  4. Generate accurate copies in human-readable format
  5. Protect records throughout retention period
  6. Validation: Audit trail captures who, what, when for all changes
Audit Trail Requirements
RequirementImplementation
SecureCannot be modified by users
Computer-generatedSystem creates automatically
Time-stampedDate and time of each action
Original valuesPrevious values retained
User identityWho made each change
Electronic Signature Requirements
RequirementImplementation
Unique to individualNot shared between persons
At least 2 componentsUser ID + password minimum
Signature manifestationName, date/time, meaning displayed
Linked to recordCannot be excised or copied
Signature Manifestation

Every electronic signature must display:

ElementExample
Printed nameJohn Smith
Date and time2024-03-15 14:32:05 EST
MeaningApproved for Release
Show full SKILL.md (584 more words)Show less
System Controls Checklist

Access Controls:

  • Unique user ID for each person
  • Password complexity enforced
  • Account lockout after failed attempts
  • Session timeout after inactivity

Audit Trail:

  • All record creation logged
  • All modifications logged with old/new values
  • User identity captured
  • Date/time stamp on all entries

Security:

  • Role-based access control
  • Encryption for data at rest and in transit
  • Regular backup and tested recovery

See references/21cfr11-compliance-guide.md for detailed compliance requirements.


Reference Documentation

Document Control Procedures

references/document-control-procedures.md contains:

  • Document numbering system and format
  • Document lifecycle stages and transitions
  • Review and approval workflow details
  • Change control process with classification criteria
  • Distribution and access control methods
  • Record retention periods and disposal procedures
  • Document Master List requirements
21 CFR Part 11 Compliance Guide

references/21cfr11-compliance-guide.md contains:

  • Part 11 scope and applicability
  • Electronic record requirements (§11.10)
  • Electronic signature requirements (§11.50, 11.100, 11.200)
  • System control specifications
  • Validation approach and documentation
  • Compliance checklist and gap assessment template
  • Common FDA deficiencies and prevention

Tools

Document Validator
bash
# Validate document metadata
python scripts/document_validator.py --doc document.json

# Interactive validation mode
python scripts/document_validator.py --interactive

# JSON output for integration
python scripts/document_validator.py --doc document.json --output json

# Generate sample document JSON
python scripts/document_validator.py --sample > sample_doc.json

Validates:

  • Document numbering convention compliance
  • Title and status requirements
  • Date validation (effective, review due)
  • Approval requirements by document type
  • Change history completeness
  • 21 CFR Part 11 controls (audit trail, signatures)
Sample Document Input
json
{
  "number": "SOP-02-001",
  "title": "Document Control Procedure",
  "doc_type": "SOP",
  "revision": "03",
  "status": "Effective",
  "effective_date": "2024-01-15",
  "review_date": "2025-01-15",
  "author": "J. Smith",
  "approver": "M. Jones",
  "change_history": [
    {"revision": "01", "date": "2022-01-01", "description": "Initial release"},
    {"revision": "02", "date": "2023-01-15", "description": "Updated workflow"},
    {"revision": "03", "date": "2024-01-15", "description": "Added e-signature requirements"}
  ],
  "has_audit_trail": true,
  "has_electronic_signature": true,
  "signature_components": 2
}

Document Control Metrics

Track document control system performance.

Key Performance Indicators
MetricTargetCalculation
Document cycle time<30 daysAverage days from draft to effective
Review completion rate>95%Reviews completed on time / Total reviews
Change request backlog<10Open change requests at month end
Overdue review rate<5%Documents past review date / Total effective
Audit finding rate<2 per auditDocument control findings per internal audit
Periodic Review Schedule
Document TypeReview Frequency
PolicyEvery 3 years
SOPEvery 2 years
WIEvery 2 years
SpecificationsAs needed or with product changes
Forms/TemplatesEvery 3 years

Regulatory Requirements

ISO 13485:2016 Clause 4.2
Sub-clauseRequirement
4.2.1Quality management system documentation
4.2.2Quality manual
4.2.3Medical device file (technical documentation)
4.2.4Control of documents
4.2.5Control of records
FDA document & record control — ISO 13485 §4.2 under the QMSR (legacy QSR sections, historical)

⚠️ STATUS — QMSR transition (effective 2026-02-02): FDA's Quality Management System Regulation (QMSR) final rule (89 FR 7496) amended 21 CFR Part 820 to incorporate ISO 13485:2016 by reference and removed the legacy QSR subsection structure. The section numbers in the table below (820.40/.180/.181/.184/.186) no longer exist in the CFR; they are retained only as a familiar index. Current document/record control authority is ISO 13485:2016 §4.2 (esp. §4.2.4 control of documents, §4.2.5 control of records), with the medical device file in §4.2.3 and records additions in retained 21 CFR 820.35. Cite the ISO 13485 clauses — not the 820.x numbers — in current compliance documentation.

Legacy QSR Section (historical, pre-2026)RequirementCurrent authority under QMSR (legacy QSR shown for index)
820.40Document controlsISO 13485 §4.2.4
820.180General record requirementsISO 13485 §4.2.5 + 21 CFR 820.35 (retained)
820.181Device master recordISO 13485 §4.2.3 (medical device file)
820.184Device history recordISO 13485 §4.2.5 + 21 CFR 820.35 (retained)
820.186Quality system recordISO 13485 §4.2.5 + 21 CFR 820.35 (retained)
Common Audit Findings
FindingPrevention
Obsolete documents in useImplement distribution control
Missing approval signaturesEnforce workflow before release
Incomplete change historyRequire history update with each revision
No periodic review scheduleEstablish and enforce review calendar
Inadequate audit trailValidate DMS for Part 11 compliance

Decision discipline: The validator scripts in this skill check structure and completeness — they do not certify a document or record as compliant. Approval and release decisions are yours and the document owner's to make under your controlled procedure; route regulatory-classification or submission-record questions to Regulatory Affairs.

© alirezarezvani, MIT. Rendered from Markdown: HTML in the file is shown as text, images as links, and headings moved down two levels. Raw file

Files

SKILL.md and 4 other files (scripts, references) in ra-qm-team/skills/quality-documentation-manager of alirezarezvani/claude-skills.

  • SKILL.md
  • references/21cfr11-compliance-guide.md
  • references/document-control-procedures.md
  • scripts/document_validator.py
  • scripts/document_version_control.py

Open the folder on GitHubat commit 19392f7

Used in 1 other repository

We found 1 copy of this SKILL.md (exact, near-identical or edited) in other folders, from 1 other GitHub owner. This page covers the copy in alirezarezvani/claude-skills, which our catalogue first saw on October 7, 2026.

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Categories

Questions about Quality Documentation Manager

What does Quality Documentation Manager do?

Document control system management for medical device QMS. An agent skill from alirezarezvani/claude-skills. Quality Documentation Manager is an agent skill from alirezarezvani/claude-skills. Document control system management for medical device QMS.

When should I use Quality Documentation Manager?

Quality Documentation Manager fits situations like: working on document control procedures; change control workflows; document numbering; version management.

How do I install Quality Documentation Manager in Claude Code?

Run `npx skills add alirezarezvani/claude-skills --skill quality-documentation-manager -a claude-code`. Or copy the skill folder (ra-qm-team/skills/quality-documentation-manager in alirezarezvani/claude-skills) into .claude/skills/quality-documentation-manager in your project. Claude Code loads it when a task matches its description.

How do I install Quality Documentation Manager in Codex?

Run `npx skills add alirezarezvani/claude-skills --skill quality-documentation-manager -a codex`. Or copy the skill folder (ra-qm-team/skills/quality-documentation-manager in alirezarezvani/claude-skills) into .agents/skills/quality-documentation-manager in your project. Codex loads it when a task matches its description.

Can I use Quality Documentation Manager in Cursor, Gemini CLI or GitHub Copilot?

Cursor, Gemini CLI, GitHub Copilot and OpenCode also load SKILL.md folders. With the skills CLI, run `npx skills add alirezarezvani/claude-skills --skill quality-documentation-manager -a cursor` (or -a gemini-cli, github-copilot or opencode for the others). To copy it by hand, put the folder in .cursor/skills/quality-documentation-manager, .gemini/skills/quality-documentation-manager, .github/skills/quality-documentation-manager and .opencode/skills/quality-documentation-manager in your project.

What does Quality Documentation Manager need to run?

Going by SKILL.md and its folder, Quality Documentation Manager needs Python for the scripts in its folder and the command-line tools its instructions call (python). Our summary lists: Python 3.

Does Quality Documentation Manager access the network?

SKILL.md contains no URLs. Any network use would come from the scripts or tools the agent runs. This is read from the text; nothing was executed.

Is Quality Documentation Manager safe to install?

Our automated static check of SKILL.md found no risky patterns, such as piping downloads into a shell, reading credential files or hidden Unicode. It is not a guarantee. The check reads SKILL.md only: the scripts in the folder are not scanned, so read them before running anything.

What licence does Quality Documentation Manager use?

Quality Documentation Manager is published under the MIT licence (the repository's licence). It allows redistribution, so the full SKILL.md is shown on this page.

How many tokens does Quality Documentation Manager use?

About 3.9k tokens (SKILL.md is roughly 16k characters). Agents keep only the skill's name and description in context until a task matches; then they load SKILL.md in full. Its references folder adds about 6.6k tokens, read only when the agent opens those files.

What are the alternatives to Quality Documentation Manager?

Skills that share tags, products or a category with Quality Documentation Manager: Finishing a Development Branch (obra/superpowers, 296k stars), Code Design Rationale Investigator (cursor/plugins, 10k stars), Contributor-First PR Merge (HKUDS/OpenHarness, 16k stars) and Migrate Internal Package into Ghost (TryGhost/Ghost, 55k stars). The comparison table on this page puts their stars, adoption, token cost, safety result and licence side by side.

Who maintains Quality Documentation Manager?

alirezarezvani (a GitHub user) maintains it in alirezarezvani/claude-skills, which has 27,829 GitHub stars. The repository holds 342 skills in this directory. The repository was last updated on August 30, 2026.

Source: alirezarezvani/claude-skills on GitHub. Facts on this page come from the repository at the commit we read; the author's words are quoted as theirs.