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        "Confirm the extracted package includes the expected docs or setup files.",
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    ],
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      {
        "label": "New install",
        "body": "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."
      },
      {
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  "documentation": {
    "source": "clawhub",
    "primaryDoc": "SKILL.md",
    "sections": [
      {
        "title": "Quality Documentation Manager",
        "body": "Document control system design and management for ISO 13485-compliant quality management systems, including numbering conventions, approval workflows, change control, and electronic record compliance."
      },
      {
        "title": "Table of Contents",
        "body": "Document Control Workflow\nDocument Numbering System\nApproval and Review Process\nChange Control Process\n21 CFR Part 11 Compliance\nReference Documentation\nTools"
      },
      {
        "title": "Document Control Workflow",
        "body": "Implement document control from creation through obsolescence:\n\nAssign document number per numbering procedure\nCreate document using controlled template\nRoute for review to required reviewers\nAddress review comments and document responses\nObtain required approval signatures\nAssign effective date and distribute\nUpdate Document Master List\nValidation: Document accessible at point of use; obsolete versions removed"
      },
      {
        "title": "Document Lifecycle Stages",
        "body": "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"
      },
      {
        "title": "Document Types and Prefixes",
        "body": "PrefixDocument TypeTypical ContentQMQuality ManualQMS overview, scope, policySOPStandard Operating ProcedureProcess-level proceduresWIWork InstructionTask-level step-by-stepTFTemplate/FormControlled formsSPECSpecificationProduct/process specsPLNPlanQuality/project plans"
      },
      {
        "title": "Required Reviewers by Document Type",
        "body": "Document TypeRequired ReviewersRequired ApproversSOPProcess Owner, QAQA Manager, Process OwnerWIArea Supervisor, QAArea ManagerSPECEngineering, QAEngineering Manager, QATFProcess OwnerQADesign DocumentsDesign Team, QADesign Control Authority"
      },
      {
        "title": "Document Numbering System",
        "body": "Assign consistent document numbers for identification and retrieval."
      },
      {
        "title": "Numbering Format",
        "body": "Standard format: PREFIX-CATEGORY-SEQUENCE[-REVISION]\n\nExample: SOP-02-001-A\n\nSOP = Document type (Standard Operating Procedure)\n02  = Category code (Document Control)\n001 = Sequential number\nA   = Revision indicator"
      },
      {
        "title": "Category Codes",
        "body": "CodeFunctional AreaDescription01Quality ManagementQMS procedures, management review02Document ControlThis area03Human ResourcesTraining, competency04Design & DevelopmentDesign control processes05PurchasingSupplier management06ProductionManufacturing procedures07Quality ControlInspection, testing08CAPACorrective/preventive actions09Risk ManagementISO 14971 processes10Regulatory AffairsSubmissions, compliance"
      },
      {
        "title": "Numbering Workflow",
        "body": "Author requests document number from Document Control\nDocument Control verifies category assignment\nDocument Control assigns next available sequence number\nNumber recorded in Document Master List\nAuthor creates document using assigned number\nValidation: Number format matches standard; no duplicates in Master List"
      },
      {
        "title": "Revision Designation",
        "body": "Change TypeRevision IncrementExampleMajor revisionIncrement numberRev 01 → Rev 02Minor revisionIncrement sub-revisionRev 01 → Rev 01.1AdministrativeNo change or letter suffixRev 01 → Rev 01a\n\nSee references/document-control-procedures.md for complete numbering guidance."
      },
      {
        "title": "Approval and Review Process",
        "body": "Obtain required reviews and approvals before document release."
      },
      {
        "title": "Review Workflow",
        "body": "Author completes document draft\nAuthor submits for review via routing form or DMS\nReviewers assigned based on document type\nReviewers provide comments within review period (5-10 business days)\nAuthor addresses comments and documents responses\nAuthor resubmits revised document\nApprovers sign and date\nValidation: All required reviewers completed; all comments addressed with documented disposition"
      },
      {
        "title": "Comment Disposition",
        "body": "DispositionAction RequiredAcceptIncorporate comment as writtenAccept with modificationIncorporate with changes, document rationaleRejectDo not incorporate, document justificationDeferAddress in future revision, document reason"
      },
      {
        "title": "Approval Matrix",
        "body": "Document Level 1 (Policy/QM): CEO or delegate + QA Manager\nDocument Level 2 (SOP): Department Manager + QA Manager\nDocument Level 3 (WI/TF): Area Supervisor + QA Representative"
      },
      {
        "title": "Signature Requirements",
        "body": "ElementRequirementNamePrinted name of signerSignatureHandwritten or electronic signatureDateDate signature appliedRoleFunction/role of signer"
      },
      {
        "title": "Change Control Process",
        "body": "Manage document changes systematically through review and approval."
      },
      {
        "title": "Change Control Workflow",
        "body": "Identify need for document change\nComplete Change Request Form with justification\nDocument Control assigns change number and logs request\nRoute to reviewers for impact assessment\nObtain approvals based on change classification\nAuthor implements approved changes\nUpdate revision number and change history\nValidation: Changes match approved scope; change history complete"
      },
      {
        "title": "Change Classification",
        "body": "ClassDefinitionApproval LevelExamplesAdministrativeNo content impactDocument ControlTypos, formattingMinorLimited content changeProcess Owner + QAClarificationsMajorSignificant content changeFull review cycleNew requirementsEmergencyUrgent safety/complianceExpedited + retrospectiveSafety issues"
      },
      {
        "title": "Impact Assessment Checklist",
        "body": "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?"
      },
      {
        "title": "Change History Documentation",
        "body": "Each document must include change history:\n\n| Revision | Date | Description | Author | Approver |\n|----------|------|-------------|--------|----------|\n| 01 | 2023-01-15 | Initial release | J. Smith | M. Jones |\n| 02 | 2024-03-01 | Updated workflow | J. Smith | M. Jones |"
      },
      {
        "title": "21 CFR Part 11 Compliance",
        "body": "Implement electronic record and signature controls for FDA compliance."
      },
      {
        "title": "Part 11 Scope",
        "body": "Applies ToDoes Not Apply ToRecords required by FDA regulationsPaper recordsRecords submitted to FDAInternal non-regulated documentsElectronic signatures on required recordsGeneral email communication"
      },
      {
        "title": "Electronic Record Controls",
        "body": "Validate system for accuracy and reliability\nImplement secure audit trail for all changes\nRestrict system access to authorized individuals\nGenerate accurate copies in human-readable format\nProtect records throughout retention period\nValidation: Audit trail captures who, what, when for all changes"
      },
      {
        "title": "Audit Trail Requirements",
        "body": "RequirementImplementationSecureCannot be modified by usersComputer-generatedSystem creates automaticallyTime-stampedDate and time of each actionOriginal valuesPrevious values retainedUser identityWho made each change"
      },
      {
        "title": "Electronic Signature Requirements",
        "body": "RequirementImplementationUnique to individualNot shared between personsAt least 2 componentsUser ID + password minimumSignature manifestationName, date/time, meaning displayedLinked to recordCannot be excised or copied"
      },
      {
        "title": "Signature Manifestation",
        "body": "Every electronic signature must display:\n\nElementExamplePrinted nameJohn SmithDate and time2024-03-15 14:32:05 ESTMeaningApproved for Release"
      },
      {
        "title": "System Controls Checklist",
        "body": "Access Controls:\n\nUnique user ID for each person\n Password complexity enforced\n Account lockout after failed attempts\n Session timeout after inactivity\n\nAudit Trail:\n\nAll record creation logged\n All modifications logged with old/new values\n User identity captured\n Date/time stamp on all entries\n\nSecurity:\n\nRole-based access control\n Encryption for data at rest and in transit\n Regular backup and tested recovery\n\nSee references/21cfr11-compliance-guide.md for detailed compliance requirements."
      },
      {
        "title": "Document Control Procedures",
        "body": "references/document-control-procedures.md contains:\n\nDocument numbering system and format\nDocument lifecycle stages and transitions\nReview and approval workflow details\nChange control process with classification criteria\nDistribution and access control methods\nRecord retention periods and disposal procedures\nDocument Master List requirements"
      },
      {
        "title": "21 CFR Part 11 Compliance Guide",
        "body": "references/21cfr11-compliance-guide.md contains:\n\nPart 11 scope and applicability\nElectronic record requirements (§11.10)\nElectronic signature requirements (§11.50, 11.100, 11.200)\nSystem control specifications\nValidation approach and documentation\nCompliance checklist and gap assessment template\nCommon FDA deficiencies and prevention"
      },
      {
        "title": "Document Validator",
        "body": "# Validate document metadata\npython scripts/document_validator.py --doc document.json\n\n# Interactive validation mode\npython scripts/document_validator.py --interactive\n\n# JSON output for integration\npython scripts/document_validator.py --doc document.json --output json\n\n# Generate sample document JSON\npython scripts/document_validator.py --sample > sample_doc.json\n\nValidates:\n\nDocument numbering convention compliance\nTitle and status requirements\nDate validation (effective, review due)\nApproval requirements by document type\nChange history completeness\n21 CFR Part 11 controls (audit trail, signatures)"
      },
      {
        "title": "Sample Document Input",
        "body": "{\n  \"number\": \"SOP-02-001\",\n  \"title\": \"Document Control Procedure\",\n  \"doc_type\": \"SOP\",\n  \"revision\": \"03\",\n  \"status\": \"Effective\",\n  \"effective_date\": \"2024-01-15\",\n  \"review_date\": \"2025-01-15\",\n  \"author\": \"J. Smith\",\n  \"approver\": \"M. Jones\",\n  \"change_history\": [\n    {\"revision\": \"01\", \"date\": \"2022-01-01\", \"description\": \"Initial release\"},\n    {\"revision\": \"02\", \"date\": \"2023-01-15\", \"description\": \"Updated workflow\"},\n    {\"revision\": \"03\", \"date\": \"2024-01-15\", \"description\": \"Added e-signature requirements\"}\n  ],\n  \"has_audit_trail\": true,\n  \"has_electronic_signature\": true,\n  \"signature_components\": 2\n}"
      },
      {
        "title": "Document Control Metrics",
        "body": "Track document control system performance."
      },
      {
        "title": "Key Performance Indicators",
        "body": "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"
      },
      {
        "title": "Periodic Review Schedule",
        "body": "Document TypeReview FrequencyPolicyEvery 3 yearsSOPEvery 2 yearsWIEvery 2 yearsSpecificationsAs needed or with product changesForms/TemplatesEvery 3 years"
      },
      {
        "title": "ISO 13485:2016 Clause 4.2",
        "body": "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"
      },
      {
        "title": "FDA 21 CFR 820",
        "body": "SectionRequirement820.40Document controls820.180General record requirements820.181Device master record820.184Device history record820.186Quality system record"
      },
      {
        "title": "Common Audit Findings",
        "body": "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"
      }
    ],
    "body": "Quality Documentation Manager\n\nDocument control system design and management for ISO 13485-compliant quality management systems, including numbering conventions, approval workflows, change control, and electronic record compliance.\n\nTable of Contents\nDocument Control Workflow\nDocument Numbering System\nApproval and Review Process\nChange Control Process\n21 CFR Part 11 Compliance\nReference Documentation\nTools\nDocument Control Workflow\n\nImplement document control from creation through obsolescence:\n\nAssign document number per numbering procedure\nCreate document using controlled template\nRoute for review to required reviewers\nAddress review comments and document responses\nObtain required approval signatures\nAssign effective date and distribute\nUpdate Document Master List\nValidation: Document accessible at point of use; obsolete versions removed\nDocument Lifecycle Stages\nStage\tDefinition\tActions Required\nDraft\tUnder creation or revision\tAuthor editing, not for use\nReview\tCirculated for review\tReviewers provide feedback\nApproved\tAll signatures obtained\tReady for training/distribution\nEffective\tTraining complete, released\tAvailable for use\nSuperseded\tReplaced by newer revision\tRemove from active use\nObsolete\tNo longer applicable\tArchive per retention schedule\nDocument Types and Prefixes\nPrefix\tDocument Type\tTypical Content\nQM\tQuality Manual\tQMS overview, scope, policy\nSOP\tStandard Operating Procedure\tProcess-level procedures\nWI\tWork Instruction\tTask-level step-by-step\nTF\tTemplate/Form\tControlled forms\nSPEC\tSpecification\tProduct/process specs\nPLN\tPlan\tQuality/project plans\nRequired Reviewers by Document Type\nDocument Type\tRequired Reviewers\tRequired Approvers\nSOP\tProcess Owner, QA\tQA Manager, Process Owner\nWI\tArea Supervisor, QA\tArea Manager\nSPEC\tEngineering, QA\tEngineering Manager, QA\nTF\tProcess Owner\tQA\nDesign Documents\tDesign Team, QA\tDesign Control Authority\nDocument Numbering System\n\nAssign consistent document numbers for identification and retrieval.\n\nNumbering Format\n\nStandard format: PREFIX-CATEGORY-SEQUENCE[-REVISION]\n\nExample: SOP-02-001-A\n\nSOP = Document type (Standard Operating Procedure)\n02  = Category code (Document Control)\n001 = Sequential number\nA   = Revision indicator\n\nCategory Codes\nCode\tFunctional Area\tDescription\n01\tQuality Management\tQMS procedures, management review\n02\tDocument Control\tThis area\n03\tHuman Resources\tTraining, competency\n04\tDesign & Development\tDesign control processes\n05\tPurchasing\tSupplier management\n06\tProduction\tManufacturing procedures\n07\tQuality Control\tInspection, testing\n08\tCAPA\tCorrective/preventive actions\n09\tRisk Management\tISO 14971 processes\n10\tRegulatory Affairs\tSubmissions, compliance\nNumbering Workflow\nAuthor requests document number from Document Control\nDocument Control verifies category assignment\nDocument Control assigns next available sequence number\nNumber recorded in Document Master List\nAuthor creates document using assigned number\nValidation: Number format matches standard; no duplicates in Master List\nRevision Designation\nChange Type\tRevision Increment\tExample\nMajor revision\tIncrement number\tRev 01 → Rev 02\nMinor revision\tIncrement sub-revision\tRev 01 → Rev 01.1\nAdministrative\tNo change or letter suffix\tRev 01 → Rev 01a\n\nSee references/document-control-procedures.md for complete numbering guidance.\n\nApproval and Review Process\n\nObtain required reviews and approvals before document release.\n\nReview Workflow\nAuthor completes document draft\nAuthor submits for review via routing form or DMS\nReviewers assigned based on document type\nReviewers provide comments within review period (5-10 business days)\nAuthor addresses comments and documents responses\nAuthor resubmits revised document\nApprovers sign and date\nValidation: All required reviewers completed; all comments addressed with documented disposition\nComment Disposition\nDisposition\tAction Required\nAccept\tIncorporate comment as written\nAccept with modification\tIncorporate with changes, document rationale\nReject\tDo not incorporate, document justification\nDefer\tAddress in future revision, document reason\nApproval Matrix\nDocument Level 1 (Policy/QM): CEO or delegate + QA Manager\nDocument Level 2 (SOP): Department Manager + QA Manager\nDocument Level 3 (WI/TF): Area Supervisor + QA Representative\n\nSignature Requirements\nElement\tRequirement\nName\tPrinted name of signer\nSignature\tHandwritten or electronic signature\nDate\tDate signature applied\nRole\tFunction/role of signer\nChange Control Process\n\nManage document changes systematically through review and approval.\n\nChange Control Workflow\nIdentify need for document change\nComplete Change Request Form with justification\nDocument Control assigns change number and logs request\nRoute to reviewers for impact assessment\nObtain approvals based on change classification\nAuthor implements approved changes\nUpdate revision number and change history\nValidation: Changes match approved scope; change history complete\nChange Classification\nClass\tDefinition\tApproval Level\tExamples\nAdministrative\tNo content impact\tDocument Control\tTypos, formatting\nMinor\tLimited content change\tProcess Owner + QA\tClarifications\nMajor\tSignificant content change\tFull review cycle\tNew requirements\nEmergency\tUrgent safety/compliance\tExpedited + retrospective\tSafety issues\nImpact Assessment Checklist\nImpact Area\tAssessment Questions\nTraining\tDoes change require retraining?\nEquipment\tDoes change affect equipment or systems?\nValidation\tDoes change require revalidation?\nRegulatory\tDoes change affect regulatory filings?\nOther Documents\tWhich related documents need updating?\nRecords\tWhat records are affected?\nChange History Documentation\n\nEach document must include change history:\n\n| Revision | Date | Description | Author | Approver |\n|----------|------|-------------|--------|----------|\n| 01 | 2023-01-15 | Initial release | J. Smith | M. Jones |\n| 02 | 2024-03-01 | Updated workflow | J. Smith | M. Jones |\n\n21 CFR Part 11 Compliance\n\nImplement electronic record and signature controls for FDA compliance.\n\nPart 11 Scope\nApplies To\tDoes Not Apply To\nRecords required by FDA regulations\tPaper records\nRecords submitted to FDA\tInternal non-regulated documents\nElectronic signatures on required records\tGeneral email communication\nElectronic Record Controls\nValidate system for accuracy and reliability\nImplement secure audit trail for all changes\nRestrict system access to authorized individuals\nGenerate accurate copies in human-readable format\nProtect records throughout retention period\nValidation: Audit trail captures who, what, when for all changes\nAudit Trail Requirements\nRequirement\tImplementation\nSecure\tCannot be modified by users\nComputer-generated\tSystem creates automatically\nTime-stamped\tDate and time of each action\nOriginal values\tPrevious values retained\nUser identity\tWho made each change\nElectronic Signature Requirements\nRequirement\tImplementation\nUnique to individual\tNot shared between persons\nAt least 2 components\tUser ID + password minimum\nSignature manifestation\tName, date/time, meaning displayed\nLinked to record\tCannot be excised or copied\nSignature Manifestation\n\nEvery electronic signature must display:\n\nElement\tExample\nPrinted name\tJohn Smith\nDate and time\t2024-03-15 14:32:05 EST\nMeaning\tApproved for Release\nSystem Controls Checklist\n\nAccess Controls:\n\n Unique user ID for each person\n Password complexity enforced\n Account lockout after failed attempts\n Session timeout after inactivity\n\nAudit Trail:\n\n All record creation logged\n All modifications logged with old/new values\n User identity captured\n Date/time stamp on all entries\n\nSecurity:\n\n Role-based access control\n Encryption for data at rest and in transit\n Regular backup and tested recovery\n\nSee references/21cfr11-compliance-guide.md for detailed compliance requirements.\n\nReference Documentation\nDocument Control Procedures\n\nreferences/document-control-procedures.md contains:\n\nDocument numbering system and format\nDocument lifecycle stages and transitions\nReview and approval workflow details\nChange control process with classification criteria\nDistribution and access control methods\nRecord retention periods and disposal procedures\nDocument Master List requirements\n21 CFR Part 11 Compliance Guide\n\nreferences/21cfr11-compliance-guide.md contains:\n\nPart 11 scope and applicability\nElectronic record requirements (§11.10)\nElectronic signature requirements (§11.50, 11.100, 11.200)\nSystem control specifications\nValidation approach and documentation\nCompliance checklist and gap assessment template\nCommon FDA deficiencies and prevention\nTools\nDocument Validator\n# Validate document metadata\npython scripts/document_validator.py --doc document.json\n\n# Interactive validation mode\npython scripts/document_validator.py --interactive\n\n# JSON output for integration\npython scripts/document_validator.py --doc document.json --output json\n\n# Generate sample document JSON\npython scripts/document_validator.py --sample > sample_doc.json\n\n\nValidates:\n\nDocument numbering convention compliance\nTitle and status requirements\nDate validation (effective, review due)\nApproval requirements by document type\nChange history completeness\n21 CFR Part 11 controls (audit trail, signatures)\nSample Document Input\n{\n  \"number\": \"SOP-02-001\",\n  \"title\": \"Document Control Procedure\",\n  \"doc_type\": \"SOP\",\n  \"revision\": \"03\",\n  \"status\": \"Effective\",\n  \"effective_date\": \"2024-01-15\",\n  \"review_date\": \"2025-01-15\",\n  \"author\": \"J. Smith\",\n  \"approver\": \"M. Jones\",\n  \"change_history\": [\n    {\"revision\": \"01\", \"date\": \"2022-01-01\", \"description\": \"Initial release\"},\n    {\"revision\": \"02\", \"date\": \"2023-01-15\", \"description\": \"Updated workflow\"},\n    {\"revision\": \"03\", \"date\": \"2024-01-15\", \"description\": \"Added e-signature requirements\"}\n  ],\n  \"has_audit_trail\": true,\n  \"has_electronic_signature\": true,\n  \"signature_components\": 2\n}\n\nDocument Control Metrics\n\nTrack document control system performance.\n\nKey Performance Indicators\nMetric\tTarget\tCalculation\nDocument cycle time\t<30 days\tAverage days from draft to effective\nReview completion rate\t>95%\tReviews completed on time / Total reviews\nChange request backlog\t<10\tOpen change requests at month end\nOverdue review rate\t<5%\tDocuments past review date / Total effective\nAudit finding rate\t<2 per audit\tDocument control findings per internal audit\nPeriodic Review Schedule\nDocument Type\tReview Frequency\nPolicy\tEvery 3 years\nSOP\tEvery 2 years\nWI\tEvery 2 years\nSpecifications\tAs needed or with product changes\nForms/Templates\tEvery 3 years\nRegulatory Requirements\nISO 13485:2016 Clause 4.2\nSub-clause\tRequirement\n4.2.1\tQuality management system documentation\n4.2.2\tQuality manual\n4.2.3\tMedical device file (technical documentation)\n4.2.4\tControl of documents\n4.2.5\tControl of records\nFDA 21 CFR 820\nSection\tRequirement\n820.40\tDocument controls\n820.180\tGeneral record requirements\n820.181\tDevice master record\n820.184\tDevice history record\n820.186\tQuality system record\nCommon Audit Findings\nFinding\tPrevention\nObsolete documents in use\tImplement distribution control\nMissing approval signatures\tEnforce workflow before release\nIncomplete change history\tRequire history update with each revision\nNo periodic review schedule\tEstablish and enforce review calendar\nInadequate audit trail\tValidate DMS for Part 11 compliance"
  },
  "trust": {
    "sourceLabel": "tencent",
    "provenanceUrl": "https://clawhub.ai/alirezarezvani/quality-documentation-manager",
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    "owner": "alirezarezvani",
    "version": "2.1.1",
    "license": null,
    "verificationStatus": "Indexed source record"
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}