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Found 8 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.
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.
Expert project management covering planning, execution, stakeholder management, risk mitigation, and delivery excellence.
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.
Repository pattern for pre-approved financial disclosures and claim language.
Create Antigravity-style implementation plans with strict review gates, line-item IDs, and no code changes until the user explicitly says Execute Plan.
Update specifications with discoveries made during development. Use when implementation reveals new requirements, constraints, or design changes.