quality-nonconformance
quality-nonconformance
Codified expertise for quality control, non-conformance investigation, root cause analysis, corrective action, and supplier quality management in regulated manufacturing.
THE SKILLS DIRECTORY
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radio-sdr
radio-sdr
Authorized RF/SDR security research: signal identification, replay-feasibility study in shielded labs, and wireless protocol analysis outside regulated bands.
stellar-asset-clawback-compliance
stellar-asset-clawback-compliance
Regulated Stellar asset clawback architecture register: issuer authorization flags, claimable balance revocations, and regulatory audit trail.
auditing-part11-trails
auditing-part11-trails
Generates and verifies 21 CFR Part 11-style audit trails — who/what/when, electronic signatures, and tamper-evidence — for OpenMed pipelines in GxP and clinical-trial (GCP) settings. Use when the user runs OpenMed in a regulated/validated environment and needs an attributable, time-stamped, tamper-evident record of each processing action, electronic-signatu…
tooluniverse-product-safety-surveillance
tooluniverse-product-safety-surveillance
Post-market safety surveillance and recall/adverse-event RETRIEVAL across the full spectrum of FDA-regulated products that are NOT covered by the drug-AE signal skills: medical devices, food / dietary supplements / cosmetics, veterinary drugs, and drug supply (shortages). Orchestrates openFDA endpoints (MAUDE device adverse events + device recalls + 510(k),…
tooluniverse-gene-regulatory-networks
tooluniverse-gene-regulatory-networks
Gene regulatory network analysis — TF-target inference (JASPAR motifs, ChIP-seq), motif scanning, eQTL integration, perturbation evidence (knockout/overexpression). Use for 'which TF regulates gene X', 'which genes does TF Y target', regulatory pathway reconstruction. Distinguishes direct (binding) vs indirect (co-expression) regulatory evidence.
tooluniverse-product-safety-surveillance
tooluniverse-product-safety-surveillance
Post-market safety surveillance and recall/adverse-event RETRIEVAL across the full spectrum of FDA-regulated products that are NOT covered by the drug-AE signal skills: medical devices, food / dietary supplements / cosmetics, veterinary drugs, and drug supply (shortages). Orchestrates openFDA endpoints (MAUDE device adverse events + device recalls + 510(k),…
tooluniverse-gene-regulatory-networks
tooluniverse-gene-regulatory-networks
Gene regulatory network analysis — TF-target inference (JASPAR motifs, ChIP-seq), motif scanning, eQTL integration, perturbation evidence (knockout/overexpression). Use for 'which TF regulates gene X', 'which genes does TF Y target', regulatory pathway reconstruction. Distinguishes direct (binding) vs indirect (co-expression) regulatory evidence.
tooluniverse-product-safety-surveillance
tooluniverse-product-safety-surveillance
Post-market safety surveillance and recall/adverse-event RETRIEVAL across the full spectrum of FDA-regulated products that are NOT covered by the drug-AE signal skills: medical devices, food / dietary supplements / cosmetics, veterinary drugs, and drug supply (shortages). Orchestrates openFDA endpoints (MAUDE device adverse events + device recalls + 510(k),…
bio-gene-regulatory-networks-coexpression-networks
bio-gene-regulatory-networks-coexpression-networks
Build weighted gene co-expression networks to identify modules of co-regulated genes, relate them to phenotypes, and find hub genes using WGCNA, hdWGCNA, MEGENA, CEMiTool, and Gaussian graphical models. Covers signed-network choice, soft-threshold selection, module preservation, and the marginal-vs-partial-correlation distinction. Use when finding co-expres…
bio-workflow-management-cwl-workflows
bio-workflow-management-cwl-workflows
Authors portable, strongly-typed bioinformatics pipelines in the Common Workflow Language (CWL v1.2) as CommandLineTool/Workflow/ExpressionTool documents, validated with cwltool and run at scale on Toil/Arvados/Calrissian. Use when deciding CWL (portability/provenance/regulated) vs Nextflow/WDL/Snakemake; declaring secondaryFiles for indexed companions (.ba…
agent-authority-charter-builder-arkadiy-miteiko
agent-authority-charter-builder-arkadiy-miteiko
Creates an Agent Authority Charter for enterprise or regulated AI agents before deployment. Use this Skill when a user needs to define what an AI agent is allowed to do, who delegated authority to it, what actions are permitted or prohibited, when human approval is required, what evidence must be preserved, and how the agent can be suspended, revoked, or es…
fintech-agreement-drafting-stephane-boghossian
fintech-agreement-drafting-stephane-boghossian
An end-to-end method for drafting and finalising a complex, multi-pillar regulated fintech agreement — from intake to signature. Authored from a senior fintech lawyer's manual: a licensed payment-services provider engaging a counterparty across agent cash-in/cash-out, QR payments, wallet e-payments, and a marketplace, each with its own regulatory profile. R…
runtime-admissibility-review
runtime-admissibility-review
Determines whether a specific AI-agent action, output, recommendation, or proposed commitment remains admissible for execution or institutional reliance under current authority, delegated scope, evidence, facts, policy, risk, escalation, and revocation conditions. Use this Skill before an enterprise or regulated AI agent executes, updates records, triggers …
srl-session-wrapper
srl-session-wrapper
Wrap a learning session in a plan → monitor → reflect cycle. Use at the start of any substantial study session to set goals, mid-session to check strategy, and at session end to consolidate what changed. Builds self-regulated learning as a habit.
hipaa-mobile-health
hipaa-mobile-health
Addresses HIPAA compliance for mobile health (mHealth) applications, wearable devices, and remote patient monitoring. Covers OCR guidance on mobile device PHI, FDA-regulated mobile medical applications, FTC Health Breach Notification Rule for non-HIPAA apps, BYOD policies, and encryption requirements for ePHI on mobile platforms. Keywords: mHealth, mobile h…
data-security-compliance-and-regulated-data
data-security-compliance-and-regulated-data
Guides agents through regulated-data security and compliance workflows for PII, PCI, HIPAA, PHI, and similar obligations. Use when data products handle sensitive fields, regulated records, control evidence, or audit-bound publish paths.
lineage-pii-and-governance
lineage-pii-and-governance
Applies governance, lineage, ownership, and sensitive-data controls to data changes. Use when a pipeline touches published datasets, regulated information, or shared business metrics.
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