Now liveThe Skillselion MCP - thousands of ranked skills, loaded into your agent mid-task. No install.Get it →
alirezarezvani avatar

Quality Documentation Manager

  • 792 installs
  • 23.5k repo stars
  • Updated July 17, 2026
  • alirezarezvani/claude-skills

Quality Documentation Manager is a Claude Code skill that generates and maintains ISO-style document control procedures, numbering systems, approval workflows, and 21 CFR Part 11 audit trails for developers building regu

About

Quality Documentation Manager is a Claude Code skill for medical-device and regulated-industry teams who need compliant document control inside a quality management system. The skill drafts document numbering schemes, version control rules, change-control workflows, electronic-signature procedures, document master lists, record-retention policies, and audit-trail requirements aligned with 21 CFR Part 11. Triggers include document control, document approval, controlled documents, and regulatory documentation review. Developers reach for Quality Documentation Manager when bootstrapping QMS documentation, preparing for audits, or standardizing how SOPs, work instructions, and regulatory records are created, revised, and approved.

  • Generates complete document control workflows from creation through obsolescence
  • Implements standardized document numbering conventions and master lists
  • Designs approval, review, and change control processes
  • Ensures 21 CFR Part 11 and ISO 13485 electronic signature and audit trail compliance
  • Produces controlled templates, record retention policies, and regulatory documentation

Quality Documentation Manager by the numbers

  • 792 all-time installs (skills.sh)
  • +12 installs in the week ending Jul 28, 2026 (Skillselion tracking)
  • Ranked #303 of 1,881 Documentation skills by installs in the Skillselion catalog
  • Security screen: HIGH risk (skills.sh audit)
  • Data as of Jul 31, 2026 (Skillselion catalog sync)
npx skills add https://github.com/alirezarezvani/claude-skills --skill quality-documentation-manager

Add your badge

Show developers this skill is listed on Skillselion. Paste this into your README.

Listed on Skillselion
Installs792
repo stars23.5k
Security audit1 / 3 scanners passed
Last updatedJuly 17, 2026
Repositoryalirezarezvani/claude-skills

How do you write QMS document control procedures?

Generate and maintain compliant document control procedures, numbering systems, approval workflows, and regulatory records for quality management systems.

Who is it for?

Developers and quality engineers at regulated hardware or medical-device companies who must stand up or audit a formal document control system.

Skip if: Teams building consumer web apps without regulatory documentation obligations who only need README or API reference docs.

When should I use this skill?

The user asks for document control, change control, document numbering, version management, electronic signatures, audit trails, or 21 CFR Part 11 compliance procedures.

What you get

Document control SOPs, numbering templates, change-control workflows, approval matrices, master document lists, and Part 11 audit-trail requirements.

  • document control SOP
  • numbering and approval workflow templates

Files

SKILL.mdMarkdownGitHub ↗

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

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

# 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

{
  "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.

Related skills

How it compares

Pick Quality Documentation Manager over general technical-writing skills when outputs must satisfy formal QMS document control and Part 11 audit requirements.

FAQ

What does Quality Documentation Manager generate?

Quality Documentation Manager generates document control procedures, numbering systems, approval workflows, change-control steps, document master lists, record-retention rules, and 21 CFR Part 11 audit-trail language for regulated quality management systems.

When should developers use Quality Documentation Manager?

Quality Documentation Manager fits medical-device, biotech, or other regulated teams bootstrapping QMS documentation, preparing audits, or standardizing how SOPs and regulatory records are created, revised, approved, and retained.

Is Quality Documentation Manager safe to install?

skills.sh reports 1 of 3 security scanners passed. Review the Security Audits panel on this page before installing in production.

Documentationdocsintegrations

This week in AI coding

Five minutes, every Monday - the tools, releases and tactics for developers.

unsubscribe anytime.