Merge feat/fda-auditor into main

2026-03-05 16:05:22 +01:00
parent f255b9163a 3b31911cdb
commit c2616f5bd4
8 changed files with 204 additions and 35 deletions
--- a/CATALOG.md
+++ b/CATALOG.md
@@ -2,7 +2,7 @@

 Generated at: 2026-02-08T00:00:00.000Z

-Total skills: 979
+Total skills: 980

 ## architecture (67)

@@ -132,7 +132,7 @@ calculations | startup, business, analyst, market, opportunity | startup, busine
 | `startup-financial-modeling` | This skill should be used when the user asks to \\\"create financial projections", "build a financial model", "forecast revenue", "calculate burn rate", "est... | startup, financial, modeling | startup, financial, modeling, skill, should, used, user, asks, projections, model, forecast, revenue |
 | `whatsapp-automation` | Automate WhatsApp Business tasks via Rube MCP (Composio): send messages, manage templates, upload media, and handle contacts. Always search tools first for c... | whatsapp | whatsapp, automation, automate, business, tasks, via, rube, mcp, composio, send, messages, upload |

-## data-ai (180)
+## data-ai (179)

 | Skill | Description | Tags | Triggers |
 | --- | --- | --- | --- |
@@ -237,7 +237,6 @@ calculations | startup, business, analyst, market, opportunity | startup, busine
 | `dbt-transformation-patterns` | Master dbt (data build tool) for analytics engineering with model organization, testing, documentation, and incremental strategies. Use when building data tr... | dbt, transformation | dbt, transformation, data, analytics, engineering, model, organization, testing, documentation, incremental, building, transformations |
 | `documentation-generation-doc-generate` | You are a documentation expert specializing in creating comprehensive, maintainable documentation from code. Generate API docs, architecture diagrams, user g... | documentation, generation, doc, generate | documentation, generation, doc, generate, specializing, creating, maintainable, code, api, docs, architecture, diagrams |
 | `documentation-templates` | Documentation templates and structure guidelines. README, API docs, code comments, and AI-friendly documentation. | documentation | documentation, structure, guidelines, readme, api, docs, code, comments, ai, friendly |
-| `drizzle-orm-expert` | Expert in Drizzle ORM for TypeScript — schema design, relational queries, migrations, and serverless database integration. Use when building type-safe databa... | drizzle, orm | drizzle, orm, typescript, schema, relational, queries, migrations, serverless, database, integration, building, type |
 | `embedding-strategies` | Select and optimize embedding models for semantic search and RAG applications. Use when choosing embedding models, implementing chunking strategies, or optim... | embedding, strategies | embedding, strategies, select, optimize, models, semantic, search, rag, applications, choosing, implementing, chunking |
 | `fal-audio` | Text-to-speech and speech-to-text using fal.ai audio models | fal, audio | fal, audio, text, speech, ai, models |
 | `fal-generate` | Generate images and videos using fal.ai AI models | fal, generate | fal, generate, images, videos, ai, models |
@@ -790,7 +789,7 @@ scripts. | bash | bash, pro, defensive, scripting, automation, ci, cd, pipelines
 | `workflow-automation` | Workflow automation is the infrastructure that makes AI agents reliable. Without durable execution, a network hiccup during a 10-step payment flow means lost... |  | automation, infrastructure, makes, ai, agents, reliable, without, durable, execution, network, hiccup, during |
 | `x-twitter-scraper` | X (Twitter) data platform skill — tweet search, user lookup, follower extraction, engagement metrics, giveaway draws, monitoring, webhooks, 19 extraction too... | [twitter, x-api, scraping, mcp, social-media, data-extraction, giveaway, monitoring, webhooks] | [twitter, x-api, scraping, mcp, social-media, data-extraction, giveaway, monitoring, webhooks], twitter, scraper, data |

-## security (116)
+## security (118)

 | Skill | Description | Tags | Triggers |
 | --- | --- | --- | --- |
@@ -830,6 +829,8 @@ scripts. | bash | bash, pro, defensive, scripting, automation, ci, cd, pipelines
 | `docker-expert` | Docker containerization expert with deep knowledge of multi-stage builds, image optimization, container security, Docker Compose orchestration, and productio... | docker | docker, containerization, deep, knowledge, multi, stage, image, optimization, container, security, compose, orchestration |
 | `dotnet-backend` | Build ASP.NET Core 8+ backend services with EF Core, auth, background jobs, and production API patterns. | dotnet, backend | dotnet, backend, asp, net, core, ef, auth, background, jobs, api |
 | `ethical-hacking-methodology` | This skill should be used when the user asks to "learn ethical hacking", "understand penetration testing lifecycle", "perform reconnaissance", "conduct secur... | ethical, hacking, methodology | ethical, hacking, methodology, skill, should, used, user, asks, learn, understand, penetration, testing |
+| `fda-food-safety-auditor` | Expert AI auditor for FDA Food Safety (FSMA), HACCP, and PCQI compliance. Reviews food facility records and preventive controls. | fda, food, safety, auditor | fda, food, safety, auditor, ai, fsma, haccp, pcqi, compliance, reviews, facility, records |
+| `fda-medtech-compliance-auditor` | Expert AI auditor for Medical Device (SaMD) compliance, IEC 62304, and 21 CFR Part 820. Reviews DHFs, technical files, and software validation. | fda, medtech, compliance, auditor | fda, medtech, compliance, auditor, ai, medical, device, samd, iec, 62304, 21, cfr |
 | `find-bugs` | Find bugs, security vulnerabilities, and code quality issues in local branch changes. Use when asked to review changes, find bugs, security review, or audit ... | find, bugs | find, bugs, security, vulnerabilities, code, quality, issues, local, branch, changes, asked, review |
 | `firebase` | Firebase gives you a complete backend in minutes - auth, database, storage, functions, hosting. But the ease of setup hides real complexity. Security rules a... | firebase | firebase, gives, complete, backend, minutes, auth, database, storage, functions, hosting, ease, setup |
 | `firmware-analyst` | Expert firmware analyst specializing in embedded systems, IoT security, and hardware reverse engineering. | firmware, analyst | firmware, analyst, specializing, embedded, iot, security, hardware, reverse, engineering |
--- a/README.md
+++ b/README.md
@@ -1,6 +1,6 @@
-# 🌌 Antigravity Awesome Skills: 979+ Agentic Skills for Claude Code, Gemini CLI, Cursor, Copilot & More
+# 🌌 Antigravity Awesome Skills: 980+ Agentic Skills for Claude Code, Gemini CLI, Cursor, Copilot & More

-> **The Ultimate Collection of 979+ Universal Agentic Skills for AI Coding Assistants — Claude Code, Gemini CLI, Codex CLI, Antigravity IDE, GitHub Copilot, Cursor, OpenCode, AdaL**
+> **The Ultimate Collection of 980+ Universal Agentic Skills for AI Coding Assistants — Claude Code, Gemini CLI, Codex CLI, Antigravity IDE, GitHub Copilot, Cursor, OpenCode, AdaL**

 [![License: MIT](https://img.shields.io/badge/License-MIT-yellow.svg)](https://opensource.org/licenses/MIT)
 [![Claude Code](https://img.shields.io/badge/Claude%20Code-Anthropic-purple)](https://claude.ai)
@@ -42,7 +42,7 @@ This repository provides essential skills to transform your AI assistant into a
 - [🎁 Curated Collections (Bundles)](#curated-collections)
 - [🧭 Antigravity Workflows](#antigravity-workflows)
 - [📦 Features & Categories](#features--categories)
- [📚 Browse 979+ Skills](#browse-979-skills)
+- [📚 Browse 980+ Skills](#browse-980-skills)
 - [🤝 How to Contribute](#how-to-contribute)
 - [💬 Community](#community)
 - [☕ Support the Project](#support-the-project)
@@ -341,7 +341,7 @@ The repository is organized into specialized domains to transform your AI into a

 Counts change as new skills are added. For the current full registry, see [CATALOG.md](CATALOG.md).

-## Browse 979+ Skills
+## Browse 980+ Skills

 We have moved the full skill registry to a dedicated catalog to keep this README clean, and we've also introduced an interactive **Web App**!

@@ -503,7 +503,6 @@ This collection would not be possible without the incredible work of the Claude
 - **[MojoAuth/skills](https://github.com/MojoAuth/skills)**: Production-ready MojoAuth guides and examples for popular frameworks like Node.js, Next.js, React, Java, .NET Core, Go, iOS, and Android.
 - **[Xquik-dev/x-twitter-scraper](https://github.com/Xquik-dev/x-twitter-scraper)**: X (Twitter) data platform — tweet search, user lookup, follower extraction, engagement metrics, giveaway draws, monitoring, webhooks, 19 extraction tools, MCP server.
 - **[shmlkv/dna-claude-analysis](https://github.com/shmlkv/dna-claude-analysis)**: Personal genome analysis toolkit — Python scripts analyzing raw DNA data across 17 categories (health risks, ancestry, pharmacogenomics, nutrition, psychology, etc.) with terminal-style single-page HTML visualization.
- **[nagisanzenin/claude-code-production-grade-plugin](https://github.com/nagisanzenin/claude-code-production-grade-plugin)**: Production Grade — 14-agent autonomous pipeline for full-project delivery. Requirements, architecture, backend, frontend, testing, security, code review, infrastructure, SRE, documentation. Two-wave parallel execution (MIT).

 ### Inspirations

--- a/data/aliases.json
+++ b/data/aliases.json
@@ -59,6 +59,7 @@
    "error-diagnostics-analysis": "error-diagnostics-error-analysis",
    "error-diagnostics-trace": "error-diagnostics-error-trace",
    "error-diagnostics-debug": "error-diagnostics-smart-debug",
+    "fda-medtech-auditor": "fda-medtech-compliance-auditor",
    "finishing-a-branch": "finishing-a-development-branch",
    "framework-migration-migrate": "framework-migration-code-migrate",
    "framework-migration-upgrade": "framework-migration-deps-upgrade",
--- a/data/bundles.json
+++ b/data/bundles.json
@@ -283,6 +283,8 @@
        "docker-expert",
        "dotnet-backend",
        "ethical-hacking-methodology",
+        "fda-food-safety-auditor",
+        "fda-medtech-compliance-auditor",
        "find-bugs",
        "firebase",
        "firmware-analyst",
--- a/data/catalog.json
+++ b/data/catalog.json
@@ -1,6 +1,6 @@
 {
  "generatedAt": "2026-02-08T00:00:00.000Z",
-  "total": 979,
+  "total": 980,
  "skills": [
    {
      "id": "00-andruia-consultant",
@@ -9871,31 +9871,6 @@
      ],
      "path": "skills/dotnet-backend-patterns/SKILL.md"
    },
-    {
-      "id": "drizzle-orm-expert",
-      "name": "drizzle-orm-expert",
-      "description": "Expert in Drizzle ORM for TypeScript — schema design, relational queries, migrations, and serverless database integration. Use when building type-safe database layers with Drizzle.",
-      "category": "data-ai",
-      "tags": [
-        "drizzle",
-        "orm"
-      ],
-      "triggers": [
-        "drizzle",
-        "orm",
-        "typescript",
-        "schema",
-        "relational",
-        "queries",
-        "migrations",
-        "serverless",
-        "database",
-        "integration",
-        "building",
-        "type"
-      ],
-      "path": "skills/drizzle-orm-expert/SKILL.md"
-    },
    {
      "id": "dropbox-automation",
      "name": "dropbox-automation",
@@ -10701,6 +10676,60 @@
      ],
      "path": "skills/fastapi-templates/SKILL.md"
    },
+    {
+      "id": "fda-food-safety-auditor",
+      "name": "fda-food-safety-auditor",
+      "description": "Expert AI auditor for FDA Food Safety (FSMA), HACCP, and PCQI compliance. Reviews food facility records and preventive controls.",
+      "category": "security",
+      "tags": [
+        "fda",
+        "food",
+        "safety",
+        "auditor"
+      ],
+      "triggers": [
+        "fda",
+        "food",
+        "safety",
+        "auditor",
+        "ai",
+        "fsma",
+        "haccp",
+        "pcqi",
+        "compliance",
+        "reviews",
+        "facility",
+        "records"
+      ],
+      "path": "skills/fda-food-safety-auditor/SKILL.md"
+    },
+    {
+      "id": "fda-medtech-compliance-auditor",
+      "name": "fda-medtech-compliance-auditor",
+      "description": "Expert AI auditor for Medical Device (SaMD) compliance, IEC 62304, and 21 CFR Part 820. Reviews DHFs, technical files, and software validation.",
+      "category": "security",
+      "tags": [
+        "fda",
+        "medtech",
+        "compliance",
+        "auditor"
+      ],
+      "triggers": [
+        "fda",
+        "medtech",
+        "compliance",
+        "auditor",
+        "ai",
+        "medical",
+        "device",
+        "samd",
+        "iec",
+        "62304",
+        "21",
+        "cfr"
+      ],
+      "path": "skills/fda-medtech-compliance-auditor/SKILL.md"
+    },
    {
      "id": "ffuf-claude-skill",
      "name": "ffuf-claude-skill",
--- a/skills/fda-food-safety-auditor/SKILL.md
+++ b/skills/fda-food-safety-auditor/SKILL.md
@@ -0,0 +1,57 @@
+---
+name: fda-food-safety-auditor
+description: "Expert AI auditor for FDA Food Safety (FSMA), HACCP, and PCQI compliance. Reviews food facility records and preventive controls."
+---
+
+# FDA Food Safety Auditor
+
+## Overview
+
+This skill transforms your AI assistant into a specialized FDA Food Safety Auditor. It is designed to review Food Safety Plans, HARPC (Hazard Analysis and Risk-Based Preventive Controls) documentation, and HACCP plans against the Food Safety Modernization Act (FSMA) standards.
+
+## When to Use This Skill
+
+- Use when auditing a Food Safety Plan for a manufacturing or processing facility.
+- Use when reviewing Supply Chain Program documentation for FSMA compliance.
+- Use when preparing for a routine FDA food facility inspection.
+- Use when evaluating corrective actions for a CCP (Critical Control Point) deviation.
+
+## How It Works
+
+1. **Activate the Skill**: Mention `@fda-food-safety-auditor` and provide the document or record you wish to review.
+2. **Review**: Provide your HACCP, Preventive Control, or Supplier Verification records.
+3. **Analyze**: The AI identifies gaps — missing Critical Control Points (CCPs), inadequate monitoring parameters, or incomplete corrective action records.
+4. **Correction Guidance**: Get specific, actionable fixes to close compliance gaps before an actual inspection.
+
+## Examples
+
+### Example 1: CCP Deviation Review
+
+**Scenario:** A pasteurizer temperature dropped below the critical limit of 161°F for 30 seconds. The operator brought it back up and logged “fixed temperature.” No product was quarantined.
+
+**Finding:**
+
+```text
+FDA AUDIT FINDING
+Severity: Major / Critical
+Citation: 21 CFR 117.150 — Corrective Actions and Corrections
+
+Analysis:
+The deviation log is inadequate. Dropping below a critical limit means
+the product may be unsafe. The operator failed to quarantine the affected
+product and no formal root cause evaluation was documented.
+
+Required Actions:
+1. Place all product produced during the deviation window on hold.
+2. Conduct a risk assessment to determine product disposition.
+3. Document a formal Corrective Action identifying the root cause
+   (e.g., valve failure, calibration drift).
+4. Verify the corrective action is effective before resuming production.
+```
+
+## Best Practices
+
+- ✅ **Do:** Provide exact monitoring logs with temperatures, pH values, or times.
+- ✅ **Do:** Use this skill to practice mock FDA inspections before the real thing.
+- ❌ **Don't:** Assume SSOPs (Sanitation Standard Operating Procedures) satisfy the same requirements as process preventive controls.
+- ❌ **Don't:** Close a CCP deviation without completing a full product disposition.
--- a/skills/fda-medtech-compliance-auditor/SKILL.md
+++ b/skills/fda-medtech-compliance-auditor/SKILL.md
@@ -0,0 +1,60 @@
+---
+name: fda-medtech-compliance-auditor
+description: "Expert AI auditor for Medical Device (SaMD) compliance, IEC 62304, and 21 CFR Part 820. Reviews DHFs, technical files, and software validation."
+---
+
+# FDA MedTech Compliance Auditor
+
+## Overview
+
+This skill transforms your AI assistant into a specialized MedTech Compliance Auditor. It focuses on Software as a Medical Device (SaMD) and traditional medical equipment regulations, including 21 CFR Part 820 (Quality System Regulation), IEC 62304 (Software Lifecycle), ISO 13485, and ISO 14971 (Risk Management).
+
+## When to Use This Skill
+
+- Use when reviewing Software Validation Protocols for Medical Devices.
+- Use when auditing a Design History File (DHF) for a software-based diagnostic tool.
+- Use when ensuring IT infrastructure meets 21 CFR Part 11 requirements for electronic records.
+- Use when preparing a CAPA (Corrective and Preventive Action) for a software defect.
+
+## How It Works
+
+1. **Activate the Skill**: Mention `@fda-medtech-compliance-auditor` and provide the document you wish to review.
+2. **Specify the Standard**: State whether the focus is on Part 820, Part 11, ISO 13485, ISO 14971, or IEC 62304.
+3. **Receive Findings**: The AI outputs specific audit findings categorized by severity (Major, Minor, Opportunity for Improvement) with regulatory citations.
+4. **Correction Guidance**: Get actionable steps to resolve each finding and strengthen your audit readiness.
+
+## Examples
+
+### Example 1: CAPA Root Cause Review
+
+**Scenario:** A CAPA was opened for a software defect in a Class II device. The documented root cause is “developer error — unclear requirements.” The corrective action is developer retraining.
+
+**Finding:**
+
+```text
+FDA AUDIT FINDING
+Severity: Major
+Citation: 21 CFR 820.100(a)(2) / IEC 62304 Section 5.1
+
+Analysis:
+"Developer error" is a symptom, not a root cause. Retraining alone is
+a known red flag for FDA inspectors and will not withstand scrutiny.
+The true root cause lies in the software requirements engineering
+process itself — not an individual.
+
+Required Actions:
+1. Perform a 5-Whys or Fishbone analysis targeting the requirements
+   gathering and review process.
+2. Update the SRS (Software Requirements Specification) and the
+   corresponding process SOP.
+3. Document an effectiveness check with a measurable criterion
+   (e.g., zero requirements-related defects in next 3 releases).
+4. Do not close the CAPA on retraining alone.
+```
+
+## Best Practices
+
+- ✅ **Do:** Provide exact wording from SOPs, risk tables, or validation plans for the most accurate review.
+- ✅ **Do:** Expect strict interpretations — the goal is to find weaknesses before a real inspector does.
+- ❌ **Don't:** Forget to link every software defect to a clinical risk item in your ISO 14971 risk file.
+- ❌ **Don't:** Assume "we tested it and it works" satisfies IEC 62304 software verification requirements.
--- a/skills_index.json
+++ b/skills_index.json
@@ -4399,6 +4399,26 @@
    "source": "community",
    "date_added": "2026-02-27"
  },
+  {
+    "id": "fda-food-safety-auditor",
+    "path": "skills/fda-food-safety-auditor",
+    "category": "uncategorized",
+    "name": "fda-food-safety-auditor",
+    "description": "Expert AI auditor for FDA Food Safety (FSMA), HACCP, and PCQI compliance. Reviews food facility records and preventive controls.",
+    "risk": "unknown",
+    "source": "unknown",
+    "date_added": null
+  },
+  {
+    "id": "fda-medtech-compliance-auditor",
+    "path": "skills/fda-medtech-compliance-auditor",
+    "category": "uncategorized",
+    "name": "fda-medtech-compliance-auditor",
+    "description": "Expert AI auditor for Medical Device (SaMD) compliance, IEC 62304, and 21 CFR Part 820. Reviews DHFs, technical files, and software validation.",
+    "risk": "unknown",
+    "source": "unknown",
+    "date_added": null
+  },
  {
    "id": "ffuf-claude-skill",
    "path": "skills/ffuf-claude-skill",