Loading...
Loading...
Found 49 Skills
INVOKE THIS SKILL when auditing an AI agent or LLM app for regulatory compliance. Covers EU AI Act, GPAI Code of Practice, GDPR, NIST AI RMF, Colorado AI Act, HIPAA, and ISO 42001. Scans the codebase for compliance gaps, cross-references Arize instrumentation for audit trail coverage, and produces an actionable remediation checklist tailored to the selected frameworks.
Margin operations: Reg T initial margin, maintenance margin, portfolio margin, margin call procedures, liquidation waterfall, SBLOC, and margin risk management.
Design and operate reconciliation processes that ensure data accuracy across portfolio management custodian and clearing systems. Use when building or evaluating a daily position cash or transaction reconciliation process, investigating discrepancies between internal systems and custodian records, diagnosing recurring break patterns especially from corporate actions or pricing differences, setting tolerance thresholds for position cash or market value matching, implementing three-way reconciliation across advisor system custodian and clearing firm, designing break investigation workflows with aging and escalation, normalizing data across multi-custodian feeds from Schwab Fidelity or Pershing, reconciling cost basis tax lots or accrued income across systems, evaluating reconciliation platforms like Arcesium Duco or Advent Geneva, or preparing for regulatory examinations on books and records accuracy.
ISO 13485 Quality Management System specialist for medical device companies. Provides QMS implementation, maintenance, process optimization, and compliance expertise. Use for QMS design, documentation control, management review, internal auditing, corrective actions, and ISO 13485 certification activities.
CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics. Use for CAPA investigations, 5-Why analysis, fishbone diagrams, root cause determination, corrective action tracking, effectiveness verification, or CAPA program optimization.
Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides quality system governance, management review leadership, regulatory compliance oversight, and quality performance monitoring per ISO 13485 Clause 5.5.2.
Draft privacy policies, terms of service, disclaimers, and legal notices. Creates GDPR-compliant texts, cookie policies, and data processing agreements. Use PROACTIVELY for legal documentation, compliance texts, or regulatory requirements.
Generate comprehensive compliance reports for security standards. Use when creating compliance documentation. Trigger with 'generate compliance report', 'compliance status', or 'audit compliance'.
When the user wants to optimize pharmacy supply chain operations, manage medication distribution, ensure pharmaceutical compliance, or handle controlled substances. Also use when the user mentions "pharmacy logistics," "drug distribution," "controlled substances," "340B program," "formulary management," "medication safety," "specialty pharmacy," "drug shortages," "DEA compliance," "pharmaceutical traceability," or "DSCSA compliance." For hospital materials management, see hospital-logistics. For clinical trial drugs, see clinical-trial-logistics.
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.
Deeper risk assessment for a single feature or product area when the launch review found something that needs more than a line item. Structured analysis: what could go wrong, how likely, how bad, what mitigates it. Use when user says "deep dive on this risk", "risk assessment for [feature]", "what could go wrong with", or when launch-review flags a novel issue.
FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QSR (21 CFR 820) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k), PMA, De Novo, QSR, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.