Requirements
- Target platform
- OpenClaw
- Install method
- Manual import
- Extraction
- Extract archive
- Prerequisites
- OpenClaw
- Primary doc
- SKILL.md
Tencent SkillHub ยท Content Creation
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 for document control procedures, change control workflow, document numbering, version management, electronic signature compliance, or regulatory documentation review.
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Document control system management for medical device QMS. Covers document numbering, version control, change management, and 21 CFR Part 11 compliance. Use for document control procedures, change control workflow, document numbering, version management, electronic signature compliance, or regulatory documentation review.
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Install for OpenClaw
Quick setup
- Download the package from Yavira.
- Extract the archive and review SKILL.md first.
- Import or place the package into your OpenClaw setup.
Package facts
- Download mode
- Yavira redirect
- Package format
- ZIP package
- Source platform
- Tencent SkillHub
- What's included
- SKILL.md, references/21cfr11-compliance-guide.md, references/document-control-procedures.md, scripts/document_validator.py
Validation
- Use the Yavira download entry.
- Review SKILL.md after the package is downloaded.
- Confirm the extracted package contains the expected setup assets.
Install with your agent
Agent handoff
Hand the extracted package to your coding agent with a concrete install brief instead of figuring it out manually.
- Download the package from Yavira.
- Extract it into a folder your agent can access.
- Paste one of the prompts below and point your agent at the extracted folder.
New install
I downloaded a skill package from Yavira. Read SKILL.md from the extracted folder and install it by following the included instructions. Tell me what you changed and call out any manual steps you could not complete.
Upgrade existing
I downloaded an updated skill package from Yavira. Read SKILL.md from the extracted folder, compare it with my current installation, and upgrade it while preserving any custom configuration unless the package docs explicitly say otherwise. Summarize what changed and any follow-up checks I should run.
Trust & source
Release facts
- Source
- Tencent SkillHub
- Verification
- Indexed source record
- Version
- 2.1.1
Provenance
- Publisher
- alirezarezvani
- Source page
- View original listing
- Canonical URL
- Open canonical page
Documentation
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 Document Numbering System Approval and Review Process Change Control Process 21 CFR Part 11 Compliance Reference Documentation Tools
Document Control Workflow
Implement document control from creation through obsolescence: Assign document number per numbering procedure Create document using controlled template Route for review to required reviewers Address review comments and document responses Obtain required approval signatures Assign effective date and distribute Update Document Master List Validation: Document accessible at point of use; obsolete versions removed
Document Lifecycle Stages
StageDefinitionActions RequiredDraftUnder creation or revisionAuthor editing, not for useReviewCirculated for reviewReviewers provide feedbackApprovedAll signatures obtainedReady for training/distributionEffectiveTraining complete, releasedAvailable for useSupersededReplaced by newer revisionRemove from active useObsoleteNo longer applicableArchive per retention schedule
Document Types and Prefixes
PrefixDocument TypeTypical ContentQMQuality ManualQMS overview, scope, policySOPStandard Operating ProcedureProcess-level proceduresWIWork InstructionTask-level step-by-stepTFTemplate/FormControlled formsSPECSpecificationProduct/process specsPLNPlanQuality/project plans
Required Reviewers by Document Type
Document TypeRequired ReviewersRequired ApproversSOPProcess Owner, QAQA Manager, Process OwnerWIArea Supervisor, QAArea ManagerSPECEngineering, QAEngineering Manager, QATFProcess OwnerQADesign 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 AreaDescription01Quality ManagementQMS procedures, management review02Document ControlThis area03Human ResourcesTraining, competency04Design & DevelopmentDesign control processes05PurchasingSupplier management06ProductionManufacturing procedures07Quality ControlInspection, testing08CAPACorrective/preventive actions09Risk ManagementISO 14971 processes10Regulatory AffairsSubmissions, compliance
Numbering Workflow
Author requests document number from Document Control Document Control verifies category assignment Document Control assigns next available sequence number Number recorded in Document Master List Author creates document using assigned number Validation: Number format matches standard; no duplicates in Master List
Revision Designation
Change TypeRevision IncrementExampleMajor revisionIncrement numberRev 01 โ Rev 02Minor revisionIncrement sub-revisionRev 01 โ Rev 01.1AdministrativeNo change or letter suffixRev 01 โ 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
Author completes document draft Author submits for review via routing form or DMS Reviewers assigned based on document type Reviewers provide comments within review period (5-10 business days) Author addresses comments and documents responses Author resubmits revised document Approvers sign and date Validation: All required reviewers completed; all comments addressed with documented disposition
Comment Disposition
DispositionAction RequiredAcceptIncorporate comment as writtenAccept with modificationIncorporate with changes, document rationaleRejectDo not incorporate, document justificationDeferAddress 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
ElementRequirementNamePrinted name of signerSignatureHandwritten or electronic signatureDateDate signature appliedRoleFunction/role of signer
Change Control Process
Manage document changes systematically through review and approval.
Change Control Workflow
Identify need for document change Complete Change Request Form with justification Document Control assigns change number and logs request Route to reviewers for impact assessment Obtain approvals based on change classification Author implements approved changes Update revision number and change history Validation: Changes match approved scope; change history complete
Change Classification
ClassDefinitionApproval LevelExamplesAdministrativeNo content impactDocument ControlTypos, formattingMinorLimited content changeProcess Owner + QAClarificationsMajorSignificant content changeFull review cycleNew requirementsEmergencyUrgent safety/complianceExpedited + retrospectiveSafety issues
Impact Assessment Checklist
Impact AreaAssessment QuestionsTrainingDoes 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 ToRecords required by FDA regulationsPaper recordsRecords submitted to FDAInternal non-regulated documentsElectronic signatures on required recordsGeneral email communication
Electronic Record Controls
Validate system for accuracy and reliability Implement secure audit trail for all changes Restrict system access to authorized individuals Generate accurate copies in human-readable format Protect records throughout retention period Validation: Audit trail captures who, what, when for all changes
Audit Trail Requirements
RequirementImplementationSecureCannot be modified by usersComputer-generatedSystem creates automaticallyTime-stampedDate and time of each actionOriginal valuesPrevious values retainedUser identityWho made each change
Electronic Signature Requirements
RequirementImplementationUnique to individualNot shared between personsAt least 2 componentsUser ID + password minimumSignature manifestationName, date/time, meaning displayedLinked to recordCannot be excised or copied
Signature Manifestation
Every electronic signature must display: ElementExamplePrinted nameJohn SmithDate and time2024-03-15 14:32:05 ESTMeaningApproved 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.
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 (ยง11.10) Electronic signature requirements (ยง11.50, 11.100, 11.200) System control specifications Validation approach and documentation Compliance checklist and gap assessment template Common FDA deficiencies and prevention
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
MetricTargetCalculationDocument cycle time<30 daysAverage days from draft to effectiveReview completion rate>95%Reviews completed on time / Total reviewsChange request backlog<10Open change requests at month endOverdue review rate<5%Documents past review date / Total effectiveAudit finding rate<2 per auditDocument control findings per internal audit
Periodic Review Schedule
Document TypeReview FrequencyPolicyEvery 3 yearsSOPEvery 2 yearsWIEvery 2 yearsSpecificationsAs needed or with product changesForms/TemplatesEvery 3 years
ISO 13485:2016 Clause 4.2
Sub-clauseRequirement4.2.1Quality management system documentation4.2.2Quality manual4.2.3Medical device file (technical documentation)4.2.4Control of documents4.2.5Control of records
FDA 21 CFR 820
SectionRequirement820.40Document controls820.180General record requirements820.181Device master record820.184Device history record820.186Quality system record
Common Audit Findings
FindingPreventionObsolete documents in useImplement distribution controlMissing approval signaturesEnforce workflow before releaseIncomplete change historyRequire history update with each revisionNo periodic review scheduleEstablish and enforce review calendarInadequate audit trailValidate DMS for Part 11 compliance
Category context
Writing, remixing, publishing, visual generation, and marketing content production.
Source: Tencent SkillHub
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Package contents
Included in package
3 Docs1 Scripts
- SKILL.md
- references/21cfr11-compliance-guide.md
- references/document-control-procedures.md
- scripts/document_validator.py