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Found 16 Skills
Manage change control for validated computerized systems. Covers change request triage (emergency, standard, minor), impact assessment on validated state, revalidation scope determination, approval workflows, implementation tracking, and post-change verification. Use when a validated system requires a software upgrade, patch, or configuration change; when infrastructure changes affect validated systems; when a CAPA requires system modification; or when emergency changes need expedited approval and retrospective documentation.
Extracts technical API constraints from OpenAPI/Swagger specs and developer docs into a contract-ready API Access & Constraints Schedule with source traceability, risk flags, and change-control language. Use when drafting legal exhibits or schedules covering API access scope, rate limits, authentication, data fields, or deprecation terms for MSAs, SOWs, or order forms.
Provides authoritative guidance on Amazon Neptune Database and Neptune Analytics for graph, knowledge-graph, and relationship-heavy workloads — fraud detection / fraud rings, agentic memory / chatbot context across sessions, recommendations, identity resolution, Gremlin / openCypher / SPARQL queries, supernode / slow traversal, Neo4j to Neptune migration / APOC compatibility, Neptune Database vs Analytics engine selection, PageRank / community detection, GraphRAG, and connectivity from Lambda / EC2 / applications. Creates and modifies Neptune Database clusters/instances and Neptune Analytics graphs on explicit user confirmation; blocks destructive operations (delete, reset-graph, failover, major upgrade) and redirects to change-control.
Update specifications with discoveries made during development. Use when implementation reveals new requirements, constraints, or design changes.
Use when deciding how big a fix should be, when scope is drifting mid-task, when a plan is being quietly trimmed to fit, or when "while you're at it" appears in any form. Encodes size-to-trigger, decompose-not-descope, and drive-to-completion. Use whenever the work is about to grow past its cause or shrink below its promise.
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.
Use when a PL/SQL change is ready to reach the database - applying a CREATE OR REPLACE, restoring from the journal, or any other write. Runs the six-step flow through pythia apply and enforces the gate - the developer sees the preview and approves in chat before anything is written, and a broken result is never reported as success.
Create Antigravity-style implementation plans with strict review gates, line-item IDs, and no code changes until the user explicitly says Execute Plan.
Expert project management covering planning, execution, stakeholder management, risk mitigation, and delivery excellence.
Repository pattern for pre-approved financial disclosures and claim language.
Internal contract: one compact frozen ACCEPTANCE.md per delivery unit, its validation ladder, anti-weakening rules, and blob-bound execution receipt. Consumed by planners, execute-phase, review-change, and loop-review-fold.
Risk & Change Management (Devil's Advocate): Identify risks, manage issues, and evaluate change requests. Use this skill to proactively detect threats, assess the impact of changes, and protect the project baseline.