[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"skill:01M737P4557W2AX341AGCCRBYQ":3,"skill-same:01M737P4557W2AX341AGCCRBYQ":65},{"skillNo":4,"name":5,"nameZh":6,"description":7,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":6,"repositoryNo":12,"starsCount":13,"licenseSpdxId":14,"licenseFileUrl":6,"sourceHtmlUrl":15,"categories":16,"keywords":17,"publishedAt":18,"linkOnly":19,"markdownContent":20,"markdownBody":21,"frontMatter":22,"refName":37,"commitSha":38,"skillDirectory":39,"forksCount":40,"repositoryHtmlUrl":41,"repositoryHomepageUrl":6,"ownerHtmlUrl":42,"ownerBlogUrl":43,"ownerDescription":6,"updatedAt":44,"install":45,"resources":58},"01M737P4557W2AX341AGCCRBYQ","conduct-gxp-audit",null,"Conduct a GxP audit of computerized systems and processes. Covers audit planning, opening meetings, evidence collection, finding classification (critical\u002Fmajor\u002Fminor), CAPA generation, closing meetings, report writing, and follow-up verification. Use for scheduled internal audits, supplier qualification audits, pre-inspection readiness assessments, for-cause audits triggered by deviations or data integrity concerns, or periodic compliance posture reviews of validated systems.","roohe\u002Fagentic-super-skills","roohe","https:\u002F\u002Favatars.githubusercontent.com\u002Fu\u002F99054084?v=4","01M734WCDFP6RZVT5CNM00QR26","01M734WCE4BD0T4NZS5PCV9V5F",10,"MIT","https:\u002F\u002Fgithub.com\u002Froohe\u002Fagentic-super-skills\u002Fblob\u002Fmaster\u002Fskills_library\u002Fconduct-gxp-audit\u002FSKILL.md",[],[],"2026-11-11 15:11:14",false,"---\nname: conduct-gxp-audit\nlocale: caveman-lite\nsource_locale: en\nsource_commit: 82c77053\ntranslator: \"Julius Brussee homage — caveman\"\ntranslation_date: \"2026-04-19\"\ndescription: >\n  Conduct a GxP audit of computerized systems and processes. Covers audit\n  planning, opening meetings, evidence collection, finding classification\n  (critical\u002Fmajor\u002Fminor), CAPA generation, closing meetings, report writing,\n  and follow-up verification. Use for scheduled internal audits, supplier\n  qualification audits, pre-inspection readiness assessments, for-cause\n  audits triggered by deviations or data integrity concerns, or periodic\n  compliance posture reviews of validated systems.\nlicense: MIT\nallowed-tools: Read Write Edit Bash Grep Glob\nmetadata:\n  author: Philipp Thoss\n  version: \"1.0\"\n  domain: compliance\n  complexity: advanced\n  language: multi\n  tags: gxp, audit, capa, inspection, compliance, quality-assurance\n---\n\n# Conduct GxP Audit\n\nPlan and execute a GxP audit of computerized systems, data integrity practices, or regulated processes.\n\n## When to Use\n\n- Scheduled internal audit of a validated computerized system\n- Supplier\u002Fvendor qualification audit for GxP-relevant software\n- Pre-inspection readiness assessment before a regulatory audit\n- For-cause audit triggered by a deviation, complaint, or data integrity concern\n- Periodic review of a validated system's compliance posture\n\n## Inputs\n\n- **Required**: Audit scope (system, process, or site to audit)\n- **Required**: Applicable regulations (21 CFR Part 11, EU Annex 11, GMP, GLP, GCP)\n- **Required**: Previous audit reports and open CAPA items\n- **Optional**: System validation documentation (URS, VP, IQ\u002FOQ\u002FPQ, traceability matrix)\n- **Optional**: SOPs, training records, change control logs\n- **Optional**: Specific risk areas or concerns triggering the audit\n\n## Procedure\n\n### Step 1: Develop the Audit Plan\n\n```markdown\n# Audit Plan\n## Document ID: AP-[SYS]-[YYYY]-[NNN]\n\n### 1. Objective\n[State the purpose: scheduled, for-cause, supplier qualification, pre-inspection]\n\n### 2. Scope\n- **System\u002FProcess**: [Name and version]\n- **Regulations**: [21 CFR Part 11, EU Annex 11, ICH Q7, etc.]\n- **Period**: [Date range of records under review]\n- **Exclusions**: [Any areas explicitly out of scope]\n\n### 3. Audit Criteria\n| Area | Regulatory Reference | Key Requirements |\n|------|---------------------|------------------|\n| Electronic records | 21 CFR 11.10 | Controls for closed systems |\n| Audit trail | 21 CFR 11.10(e) | Secure, computer-generated, time-stamped |\n| Electronic signatures | 21 CFR 11.50 | Manifestation, legally binding |\n| Access controls | EU Annex 11, §12 | Role-based, documented |\n| Data integrity | MHRA guidance | ALCOA+ principles |\n| Change control | ICH Q10 | Documented, assessed, approved |\n\n### 4. Schedule\n| Date | Time | Activity | Participants |\n|------|------|----------|-------------|\n| Day 1 AM | 09:00 | Opening meeting | All |\n| Day 1 AM | 10:00 | Document review | Auditor + QA |\n| Day 1 PM | 13:00 | System walkthrough | Auditor + IT + System Owner |\n| Day 2 AM | 09:00 | Interviews + evidence collection | Auditor + Users |\n| Day 2 PM | 14:00 | Finding consolidation | Auditor |\n| Day 2 PM | 16:00 | Closing meeting | All |\n\n### 5. Audit Team\n| Role | Name | Responsibility |\n|------|------|---------------|\n| Lead Auditor | [Name] | Plan, execute, report |\n| Subject Matter Expert | [Name] | Technical assessment |\n| Auditee Representative | [Name] | Facilitate access and information |\n```\n\n**Got:** Audit plan approved by quality management and communicated to auditee at least 2 weeks before the audit.\n**If fail:** Reschedule if auditee cannot provide required documentation or personnel.\n\n### Step 2: Conduct Opening Meeting\n\nAgenda:\n1. Introduce audit team and roles\n2. Confirm scope, schedule, and logistics\n3. Explain finding classification system (critical\u002Fmajor\u002Fminor)\n4. Confirm confidentiality agreements\n5. Identify auditee escorts and document custodians\n6. Address questions\n\n**Got:** Opening meeting documented with attendance record.\n**If fail:** If key personnel are unavailable, reschedule affected audit activities.\n\n### Step 3: Collect and Review Evidence\n\nReview documentation and records against audit criteria:\n\n#### 3a. Validation Documentation Review\n- [ ] URS exists and is approved\n- [ ] Validation plan matches system category and risk\n- [ ] IQ\u002FOQ\u002FPQ protocols executed with results documented\n- [ ] Traceability matrix links requirements to test results\n- [ ] Deviations documented and resolved\n- [ ] Validation summary report approved\n\n#### 3b. Operational Controls Review\n- [ ] SOPs current and approved\n- [ ] Training records demonstrate competence for all users\n- [ ] Change control records complete (request, assessment, approval, verification)\n- [ ] Incident\u002Fdeviation reports handled per SOP\n- [ ] Periodic review conducted on schedule\n\n#### 3c. Data Integrity Assessment\n- [ ] Audit trail enabled and not modifiable by users\n- [ ] Electronic signatures meet regulatory requirements\n- [ ] Backup and recovery procedures documented and tested\n- [ ] Access controls enforce role-based permissions\n- [ ] Data is attributable, legible, contemporaneous, original, accurate (ALCOA+)\n\n#### 3d. System Configuration Review\n- [ ] Production configuration matches validated state\n- [ ] User accounts reviewed — no shared accounts, inactive accounts disabled\n- [ ] System clocks synchronized and accurate\n- [ ] Security patches applied per approved change control\n\n**Got:** Evidence collected as screenshots, document copies, interview notes with timestamps.\n**If fail:** Record \"unable to verify\" as an observation and note the reason.\n\n### Step 4: Classify Findings\n\nClassify each finding by severity:\n\n| Classification | Definition | Response Required |\n|---------------|------------|-------------------|\n| **Critical** | Direct impact on product quality, patient safety, or data integrity. Systematic failure of a key control. | Immediate containment + CAPA within 15 business days |\n| **Major** | Significant departure from GxP requirements. Potential to impact data integrity if uncorrected. | CAPA within 30 business days |\n| **Minor** | Isolated deviation from procedure. No direct impact on data integrity or product quality. | Correction within 60 business days |\n| **Observation** | Opportunity for improvement. Not a regulatory requirement. | Optional — tracked for trend analysis |\n\nDocument each finding:\n\n```markdown\n## Finding F-[NNN]\n**Classification:** [Critical \u002F Major \u002F Minor \u002F Observation]\n**Area:** [Audit trail \u002F Access control \u002F Change control \u002F etc.]\n**Reference:** [Regulatory clause, e.g., 21 CFR 11.10(e)]\n\n**Observation:**\n[Objective description of what was found]\n\n**Evidence:**\n[Document ID, screenshot reference, interview notes]\n\n**Regulatory Expectation:**\n[What the regulation requires]\n\n**Risk:**\n[Impact on data integrity, product quality, or patient safety]\n```\n\n**Got:** Every finding has classification, evidence, and regulatory reference.\n**If fail:** If classification is disputed, escalate to the audit program manager for adjudication.\n\n### Step 5: Conduct Closing Meeting\n\nAgenda:\n1. Present findings summary (no new findings should be raised)\n2. Review finding classifications\n3. Discuss preliminary CAPA expectations and timelines\n4. Confirm next steps and report timeline\n5. Acknowledge auditee cooperation\n\n**Got:** Closing meeting documented with attendance. Auditee acknowledges findings (acknowledgement ≠ agreement).\n**If fail:** If auditee disputes a finding, document the disagreement and escalate per SOP.\n\n### Step 6: Write Audit Report\n\n```markdown\n# Audit Report\n## Document ID: AR-[SYS]-[YYYY]-[NNN]\n\n### 1. Executive Summary\nAn audit of [System\u002FProcess] was conducted on [dates] against [regulations].\n[N] findings were identified: [n] critical, [n] major, [n] minor, [n] observations.\n\n### 2. Scope and Methodology\n[Summarize audit plan scope, criteria, and methods used]\n\n### 3. Findings Summary\n| Finding ID | Classification | Area | Brief Description |\n|-----------|---------------|------|-------------------|\n| F-001 | Major | Audit trail | Audit trail disabled for batch record module |\n| F-002 | Minor | Training | Two users missing annual GxP training |\n| F-003 | Observation | Documentation | SOP formatting inconsistencies |\n\n### 4. Detailed Findings\n[Include full finding details from Step 4 for each finding]\n\n### 5. Positive Observations\n[Document areas of good practice observed during the audit]\n\n### 6. Conclusion\nThe overall compliance status is assessed as [Satisfactory \u002F Needs Improvement \u002F Unsatisfactory].\n\n### 7. Distribution\n| Recipient | Role |\n|-----------|------|\n| [Name] | System Owner |\n| [Name] | QA Director |\n| [Name] | IT Manager |\n\n### Approval\n| Role | Name | Signature | Date |\n|------|------|-----------|------|\n| Lead Auditor | | | |\n| QA Director | | | |\n```\n\n**Got:** Report issued within 15 business days of the closing meeting.\n**If fail:** If delayed beyond 15 days, notify stakeholders and document the reason.\n\n### Step 7: Track CAPA and Verify Effectiveness\n\nFor each finding requiring a CAPA:\n\n```markdown\n## CAPA Tracking\n| Finding ID | CAPA ID | Root Cause | Corrective Action | Due Date | Status | Effectiveness Check |\n|-----------|---------|------------|-------------------|----------|--------|-------------------|\n| F-001 | CAPA-2025-042 | Configuration oversight during upgrade | Enable audit trail, verify all modules | 2025-04-15 | Open | Scheduled 2025-07-15 |\n| F-002 | CAPA-2025-043 | Training matrix not updated | Complete training, update tracking | 2025-05-01 | Open | Scheduled 2025-08-01 |\n```\n\n**Got:** CAPAs assigned, tracked, and effectiveness verified per defined timeline.\n**If fail:** Unresolved CAPAs escalate to QA management and are flagged in the next audit cycle.\n\n## Validation\n\n- [ ] Audit plan approved and communicated before audit\n- [ ] Opening and closing meetings documented with attendance\n- [ ] Evidence collected with timestamps and source references\n- [ ] Every finding has classification, evidence, and regulatory reference\n- [ ] Audit report issued within 15 business days\n- [ ] CAPAs assigned with due dates for all critical and major findings\n- [ ] Previous audit CAPAs verified for closure effectiveness\n\n## Pitfalls\n\n- **Scope creep**: Expanding the audit scope during execution without formal agreement leads to incomplete coverage and disputes.\n- **Opinion-based findings**: Findings must reference specific regulatory requirements, not personal preferences.\n- **Adversarial tone**: Audits are collaborative quality improvement exercises, not interrogations.\n- **Ignoring positives**: Reporting only findings without acknowledging good practices undermines trust.\n- **No effectiveness check**: Closing a CAPA without verifying the fix actually works is a recurring regulatory citation.\n\n## Related Skills\n\n- `perform-csv-assessment` — full CSV lifecycle assessment (URS through validation summary)\n- `setup-gxp-r-project` — project structure for validated R environments\n- `implement-audit-trail` — audit trail implementation for electronic records\n- `write-validation-documentation` — IQ\u002FOQ\u002FPQ protocol and report writing\n- `security-audit-codebase` — security-focused code audit (complementary perspective)\n","# Conduct GxP Audit\n\nPlan and execute a GxP audit of computerized systems, data integrity practices, or regulated processes.\n\n## When to Use\n\n- Scheduled internal audit of a validated computerized system\n- Supplier\u002Fvendor qualification audit for GxP-relevant software\n- Pre-inspection readiness assessment before a regulatory audit\n- For-cause audit triggered by a deviation, complaint, or data integrity concern\n- Periodic review of a validated system's compliance posture\n\n## Inputs\n\n- **Required**: Audit scope (system, process, or site to audit)\n- **Required**: Applicable regulations (21 CFR Part 11, EU Annex 11, GMP, GLP, GCP)\n- **Required**: Previous audit reports and open CAPA items\n- **Optional**: System validation documentation (URS, VP, IQ\u002FOQ\u002FPQ, traceability matrix)\n- **Optional**: SOPs, training records, change control logs\n- **Optional**: Specific risk areas or concerns triggering the audit\n\n## Procedure\n\n### Step 1: Develop the Audit Plan\n\n```markdown\n# Audit Plan\n## Document ID: AP-[SYS]-[YYYY]-[NNN]\n\n### 1. Objective\n[State the purpose: scheduled, for-cause, supplier qualification, pre-inspection]\n\n### 2. Scope\n- **System\u002FProcess**: [Name and version]\n- **Regulations**: [21 CFR Part 11, EU Annex 11, ICH Q7, etc.]\n- **Period**: [Date range of records under review]\n- **Exclusions**: [Any areas explicitly out of scope]\n\n### 3. Audit Criteria\n| Area | Regulatory Reference | Key Requirements |\n|------|---------------------|------------------|\n| Electronic records | 21 CFR 11.10 | Controls for closed systems |\n| Audit trail | 21 CFR 11.10(e) | Secure, computer-generated, time-stamped |\n| Electronic signatures | 21 CFR 11.50 | Manifestation, legally binding |\n| Access controls | EU Annex 11, §12 | Role-based, documented |\n| Data integrity | MHRA guidance | ALCOA+ principles |\n| Change control | ICH Q10 | Documented, assessed, approved |\n\n### 4. Schedule\n| Date | Time | Activity | Participants |\n|------|------|----------|-------------|\n| Day 1 AM | 09:00 | Opening meeting | All |\n| Day 1 AM | 10:00 | Document review | Auditor + QA |\n| Day 1 PM | 13:00 | System walkthrough | Auditor + IT + System Owner |\n| Day 2 AM | 09:00 | Interviews + evidence collection | Auditor + Users |\n| Day 2 PM | 14:00 | Finding consolidation | Auditor |\n| Day 2 PM | 16:00 | Closing meeting | All |\n\n### 5. Audit Team\n| Role | Name | Responsibility |\n|------|------|---------------|\n| Lead Auditor | [Name] | Plan, execute, report |\n| Subject Matter Expert | [Name] | Technical assessment |\n| Auditee Representative | [Name] | Facilitate access and information |\n```\n\n**Got:** Audit plan approved by quality management and communicated to auditee at least 2 weeks before the audit.\n**If fail:** Reschedule if auditee cannot provide required documentation or personnel.\n\n### Step 2: Conduct Opening Meeting\n\nAgenda:\n1. Introduce audit team and roles\n2. Confirm scope, schedule, and logistics\n3. Explain finding classification system (critical\u002Fmajor\u002Fminor)\n4. Confirm confidentiality agreements\n5. Identify auditee escorts and document custodians\n6. Address questions\n\n**Got:** Opening meeting documented with attendance record.\n**If fail:** If key personnel are unavailable, reschedule affected audit activities.\n\n### Step 3: Collect and Review Evidence\n\nReview documentation and records against audit criteria:\n\n#### 3a. Validation Documentation Review\n- [ ] URS exists and is approved\n- [ ] Validation plan matches system category and risk\n- [ ] IQ\u002FOQ\u002FPQ protocols executed with results documented\n- [ ] Traceability matrix links requirements to test results\n- [ ] Deviations documented and resolved\n- [ ] Validation summary report approved\n\n#### 3b. Operational Controls Review\n- [ ] SOPs current and approved\n- [ ] Training records demonstrate competence for all users\n- [ ] Change control records complete (request, assessment, approval, verification)\n- [ ] Incident\u002Fdeviation reports handled per SOP\n- [ ] Periodic review conducted on schedule\n\n#### 3c. Data Integrity Assessment\n- [ ] Audit trail enabled and not modifiable by users\n- [ ] Electronic signatures meet regulatory requirements\n- [ ] Backup and recovery procedures documented and tested\n- [ ] Access controls enforce role-based permissions\n- [ ] Data is attributable, legible, contemporaneous, original, accurate (ALCOA+)\n\n#### 3d. System Configuration Review\n- [ ] Production configuration matches validated state\n- [ ] User accounts reviewed — no shared accounts, inactive accounts disabled\n- [ ] System clocks synchronized and accurate\n- [ ] Security patches applied per approved change control\n\n**Got:** Evidence collected as screenshots, document copies, interview notes with timestamps.\n**If fail:** Record \"unable to verify\" as an observation and note the reason.\n\n### Step 4: Classify Findings\n\nClassify each finding by severity:\n\n| Classification | Definition | Response Required |\n|---------------|------------|-------------------|\n| **Critical** | Direct impact on product quality, patient safety, or data integrity. Systematic failure of a key control. | Immediate containment + CAPA within 15 business days |\n| **Major** | Significant departure from GxP requirements. Potential to impact data integrity if uncorrected. | CAPA within 30 business days |\n| **Minor** | Isolated deviation from procedure. No direct impact on data integrity or product quality. | Correction within 60 business days |\n| **Observation** | Opportunity for improvement. Not a regulatory requirement. | Optional — tracked for trend analysis |\n\nDocument each finding:\n\n```markdown\n## Finding F-[NNN]\n**Classification:** [Critical \u002F Major \u002F Minor \u002F Observation]\n**Area:** [Audit trail \u002F Access control \u002F Change control \u002F etc.]\n**Reference:** [Regulatory clause, e.g., 21 CFR 11.10(e)]\n\n**Observation:**\n[Objective description of what was found]\n\n**Evidence:**\n[Document ID, screenshot reference, interview notes]\n\n**Regulatory Expectation:**\n[What the regulation requires]\n\n**Risk:**\n[Impact on data integrity, product quality, or patient safety]\n```\n\n**Got:** Every finding has classification, evidence, and regulatory reference.\n**If fail:** If classification is disputed, escalate to the audit program manager for adjudication.\n\n### Step 5: Conduct Closing Meeting\n\nAgenda:\n1. Present findings summary (no new findings should be raised)\n2. Review finding classifications\n3. Discuss preliminary CAPA expectations and timelines\n4. Confirm next steps and report timeline\n5. Acknowledge auditee cooperation\n\n**Got:** Closing meeting documented with attendance. Auditee acknowledges findings (acknowledgement ≠ agreement).\n**If fail:** If auditee disputes a finding, document the disagreement and escalate per SOP.\n\n### Step 6: Write Audit Report\n\n```markdown\n# Audit Report\n## Document ID: AR-[SYS]-[YYYY]-[NNN]\n\n### 1. Executive Summary\nAn audit of [System\u002FProcess] was conducted on [dates] against [regulations].\n[N] findings were identified: [n] critical, [n] major, [n] minor, [n] observations.\n\n### 2. Scope and Methodology\n[Summarize audit plan scope, criteria, and methods used]\n\n### 3. Findings Summary\n| Finding ID | Classification | Area | Brief Description |\n|-----------|---------------|------|-------------------|\n| F-001 | Major | Audit trail | Audit trail disabled for batch record module |\n| F-002 | Minor | Training | Two users missing annual GxP training |\n| F-003 | Observation | Documentation | SOP formatting inconsistencies |\n\n### 4. Detailed Findings\n[Include full finding details from Step 4 for each finding]\n\n### 5. Positive Observations\n[Document areas of good practice observed during the audit]\n\n### 6. Conclusion\nThe overall compliance status is assessed as [Satisfactory \u002F Needs Improvement \u002F Unsatisfactory].\n\n### 7. Distribution\n| Recipient | Role |\n|-----------|------|\n| [Name] | System Owner |\n| [Name] | QA Director |\n| [Name] | IT Manager |\n\n### Approval\n| Role | Name | Signature | Date |\n|------|------|-----------|------|\n| Lead Auditor | | | |\n| QA Director | | | |\n```\n\n**Got:** Report issued within 15 business days of the closing meeting.\n**If fail:** If delayed beyond 15 days, notify stakeholders and document the reason.\n\n### Step 7: Track CAPA and Verify Effectiveness\n\nFor each finding requiring a CAPA:\n\n```markdown\n## CAPA Tracking\n| Finding ID | CAPA ID | Root Cause | Corrective Action | Due Date | Status | Effectiveness Check |\n|-----------|---------|------------|-------------------|----------|--------|-------------------|\n| F-001 | CAPA-2025-042 | Configuration oversight during upgrade | Enable audit trail, verify all modules | 2025-04-15 | Open | Scheduled 2025-07-15 |\n| F-002 | CAPA-2025-043 | Training matrix not updated | Complete training, update tracking | 2025-05-01 | Open | Scheduled 2025-08-01 |\n```\n\n**Got:** CAPAs assigned, tracked, and effectiveness verified per defined timeline.\n**If fail:** Unresolved CAPAs escalate to QA management and are flagged in the next audit cycle.\n\n## Validation\n\n- [ ] Audit plan approved and communicated before audit\n- [ ] Opening and closing meetings documented with attendance\n- [ ] Evidence collected with timestamps and source references\n- [ ] Every finding has classification, evidence, and regulatory reference\n- [ ] Audit report issued within 15 business days\n- [ ] CAPAs assigned with due dates for all critical and major findings\n- [ ] Previous audit CAPAs verified for closure effectiveness\n\n## Pitfalls\n\n- **Scope creep**: Expanding the audit scope during execution without formal agreement leads to incomplete coverage and disputes.\n- **Opinion-based findings**: Findings must reference specific regulatory requirements, not personal preferences.\n- **Adversarial tone**: Audits are collaborative quality improvement exercises, not interrogations.\n- **Ignoring positives**: Reporting only findings without acknowledging good practices undermines trust.\n- **No effectiveness check**: Closing a CAPA without verifying the fix actually works is a recurring regulatory citation.\n\n## Related Skills\n\n- `perform-csv-assessment` — full CSV lifecycle assessment (URS through validation summary)\n- `setup-gxp-r-project` — project structure for validated R environments\n- `implement-audit-trail` — audit trail implementation for electronic records\n- `write-validation-documentation` — IQ\u002FOQ\u002FPQ protocol and report writing\n- `security-audit-codebase` — security-focused code audit (complementary perspective)\n",{"name":5,"locale":23,"license":14,"metadata":24,"translator":31,"description":32,"allowed-tools":33,"source_commit":34,"source_locale":35,"translation_date":36},"caveman-lite",{"tags":25,"author":26,"domain":27,"version":28,"language":29,"complexity":30},"gxp, audit, capa, inspection, compliance, quality-assurance","Philipp Thoss","compliance","1.0","multi","advanced","Julius Brussee homage — caveman","Conduct a GxP audit of computerized systems and processes. Covers audit planning, opening meetings, evidence collection, finding classification (critical\u002Fmajor\u002Fminor), CAPA generation, closing meetings, report writing, and follow-up verification. Use for scheduled internal audits, supplier qualification audits, pre-inspection readiness assessments, for-cause audits triggered by deviations or data integrity concerns, or periodic compliance posture reviews of validated systems.\n","Read Write Edit Bash Grep Glob","82c77053","en","2026-04-19","master","f483e54f3ad5f202a77d45f2e57f8d970b71195f","skills_library\u002Fconduct-gxp-audit",2,"https:\u002F\u002Fgithub.com\u002Froohe\u002Fagentic-super-skills","https:\u002F\u002Fgithub.com\u002Froohe","yoou.link","2026-05-19 15:56:07",{"source":8,"skillName":5,"commands":46,"prompt":56,"zipAvailable":57},[47,50,53],{"tool":48,"command":49},"npx","npx skills add roohe\u002Fagentic-super-skills --skill conduct-gxp-audit",{"tool":51,"command":52},"bunx","bunx skills add roohe\u002Fagentic-super-skills --skill conduct-gxp-audit",{"tool":54,"command":55},"pnpm","pnpm dlx skills add roohe\u002Fagentic-super-skills --skill conduct-gxp-audit","安装技能，技能地址：https:\u002F\u002Fgithub.com\u002Froohe\u002Fagentic-super-skills\u002Fblob\u002Fmaster\u002Fskills_library\u002Fconduct-gxp-audit\u002FSKILL.md",true,[59],{"path":60,"resourceType":61,"resourceTypeDesc":62,"sizeBytes":63,"sourceHtmlUrl":64},"references\u002FCITATIONS.bib","REFERENCE","参考文档",2358,"https:\u002F\u002Fgithub.com\u002Froohe\u002Fagentic-super-skills\u002Fblob\u002Fmaster\u002Fskills_library\u002Fconduct-gxp-audit\u002Freferences\u002FCITATIONS.bib",[66,73,80,87,94,101],{"skillNo":67,"name":68,"nameZh":6,"description":69,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":6,"repositoryNo":12,"starsCount":13,"licenseSpdxId":14,"licenseFileUrl":6,"sourceHtmlUrl":70,"categories":71,"keywords":72,"publishedAt":18},"01M73D865CZME2FCMKA4PQM348","zarr-python","Chunked N-D arrays for cloud storage. Compressed arrays, parallel I\u002FO, S3\u002FGCS integration, NumPy\u002FDask\u002FXarray compatible, for large-scale scientific computing pipelines.","https:\u002F\u002Fgithub.com\u002Froohe\u002Fagentic-super-skills\u002Fblob\u002Fmaster\u002Fskills_library\u002Fzarr-python\u002FSKILL.md",[],[],{"skillNo":74,"name":75,"nameZh":6,"description":76,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":6,"repositoryNo":12,"starsCount":13,"licenseSpdxId":14,"licenseFileUrl":6,"sourceHtmlUrl":77,"categories":78,"keywords":79,"publishedAt":18},"01M73D7Z64J4ABWZJD7P44XBBF","youtube-downloader","Download and process YouTube content for research. Use when: downloading competitor videos for analysis; extracting audio for podcasts; getting transcripts for content repurposing; archiving webinars; research content curation","https:\u002F\u002Fgithub.com\u002Froohe\u002Fagentic-super-skills\u002Fblob\u002Fmaster\u002Fskills_library\u002Fyoutube-downloader\u002FSKILL.md",[],[],{"skillNo":81,"name":82,"nameZh":6,"description":83,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":6,"repositoryNo":12,"starsCount":13,"licenseSpdxId":14,"licenseFileUrl":6,"sourceHtmlUrl":84,"categories":85,"keywords":86,"publishedAt":18},"01M73D7K8778TGZV3GJFR3703D","yc-pitch-deck","Create a compelling startup pitch deck that follows the structure proven to raise billions from top investors. Master the YC and Sequoia formats that get founders funded. Use when: **Fundraising** to create investor pitch decks; **YC application** to structure your narrative; **Demo Day prep** to craft your 2-minute pitch; **Angel investors** to communicate your opportunity; **Partnership pitches** to structure compelling asks","https:\u002F\u002Fgithub.com\u002Froohe\u002Fagentic-super-skills\u002Fblob\u002Fmaster\u002Fskills_library\u002Fyc-pitch-deck\u002FSKILL.md",[],[],{"skillNo":88,"name":89,"nameZh":6,"description":90,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":6,"repositoryNo":12,"starsCount":13,"licenseSpdxId":14,"licenseFileUrl":6,"sourceHtmlUrl":91,"categories":92,"keywords":93,"publishedAt":18},"01M73D70KJSE0E8Z28YMNNRT04","x-twitter-scraper","Use when the user needs X (Twitter) data or confirmation-gated X actions through Xquik: tweet search, user lookup, follower extraction, media download, monitoring, webhooks, MCP, SDKs, posting, likes, DMs, and profile updates. Requires a Xquik API key. Never ask for X login material.","https:\u002F\u002Fgithub.com\u002Froohe\u002Fagentic-super-skills\u002Fblob\u002Fmaster\u002Fskills_library\u002Fx-twitter-scraper\u002FSKILL.md",[],[],{"skillNo":95,"name":96,"nameZh":6,"description":97,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":6,"repositoryNo":12,"starsCount":13,"licenseSpdxId":14,"licenseFileUrl":6,"sourceHtmlUrl":98,"categories":99,"keywords":100,"publishedAt":18},"01M73D6ED01GV077R7K4NZNFZJ","write-vignette","Create R package vignettes using R Markdown or Quarto. Covers vignette setup, YAML configuration, code chunk options, building and testing, and CRAN requirements for vignettes. Use when adding a Getting Started tutorial, documenting complex workflows spanning multiple functions, creating domain-specific guides, or when CRAN submission requires user-facing documentation beyond function help pages.","https:\u002F\u002Fgithub.com\u002Froohe\u002Fagentic-super-skills\u002Fblob\u002Fmaster\u002Fskills_library\u002Fwrite-vignette\u002FSKILL.md",[],[],{"skillNo":102,"name":103,"nameZh":6,"description":104,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":6,"repositoryNo":12,"starsCount":13,"licenseSpdxId":14,"licenseFileUrl":6,"sourceHtmlUrl":105,"categories":106,"keywords":107,"publishedAt":18},"01M73D69YJR0BK3NFHE0CYG3EF","write-validation-documentation","Write IQ\u002FOQ\u002FPQ validation documentation for computerized systems in regulated environments. Covers protocols, reports, test scripts, deviation handling, and approval workflows. Use when validating R or other software for regulated use, preparing for a regulatory audit, documenting qualification of computing environments, or creating and updating validation protocols and reports for new or re-qualified systems.","https:\u002F\u002Fgithub.com\u002Froohe\u002Fagentic-super-skills\u002Fblob\u002Fmaster\u002Fskills_library\u002Fwrite-validation-documentation\u002FSKILL.md",[],[]]