Governance & Program Info
Pharmacy Automation & Smart Formulary Management — Governance
Cross-builder institution context and per-item ownership, due dates, status, and next actions for the governance-relevant checklist items in this builder.
Institution context
Program info
Applies across every builder in the app. Stored locally; nothing leaves the browser.
Checklist governance
Items (0 of 16 marked complete)
Annotate ownership, due date, status, and next action. Items on the left come from the builder's governance / compliance phases.
05 · Governance & Compliance
Align to FDA AI/ML-enabled pharmacy automation draft guidance (March 2026)
Map the verification model to the FDA's March 2026 draft guidance — predetermined change control plan, validation expectations, post-market monitoring.
05 · Governance & Compliance
IEC 62304 software lifecycle and ISO 13485 QMS alignment
If the model is a medical device or a component of one, IEC 62304 software lifecycle and ISO 13485 quality system apply.
05 · Governance & Compliance
21 CFR Part 11 electronic records and signatures
Verification decisions, model versions, and pharmacist approvals are electronic records — Part 11 controls apply.
05 · Governance & Compliance
NIST AI RMF 1.0 alignment
NIST AI Risk Management Framework 1.0 as the governance scaffold — Govern / Map / Measure / Manage functions.
05 · Governance & Compliance
Map HIPAA 45 CFR 160/164 controls across the ML stack
Inventory which controls (access, audit, encryption, minimum necessary) apply to training, feature store, inference, and audit log.
05 · Governance & Compliance
DEA Controlled Substances Act compliance for schedule dispensing
Schedule II–V dispensing logs, biometric witness, and discrepancy resolution under DEA rules.
05 · Governance & Compliance
USP <797> sterile / <800> hazardous compounding controls
If the program touches compounding, USP <797> / <800> controls on containment, BUD, and documentation apply to the ML layer.
05 · Governance & Compliance
State pharmacy board and NABP compliance documentation
Maintain the per-state compliance matrix for automated dispensing, tech-check-tech, and AI-verification allowances.
05 · Governance & Compliance
ISMP guideline alignment for safe dispensing
ISMP Medication Safety guidelines — high-alert list, LASA, bar-code at bedside, error-prone abbreviations.
05 · Governance & Compliance
503A / 503B facility classification (if applicable)
Outsourcing facilities under 503B have cGMP obligations; 503A pharmacy compounding is state-regulated — scope the model accordingly.
05 · Governance & Compliance
Complete model documentation package
Purpose, data lineage, assumptions, limitations, known failure modes, validation results — all components auditors and the medication-safety committee expect.
05 · Governance & Compliance
Independent model validation
Second-line or external team validates model logic, training data, and performance claims. Independent of development.
05 · Governance & Compliance
Change management and model versioning
Who approves model updates, what validation is required, how are changes versioned and rolled back, what is the audit trail.
05 · Governance & Compliance
ONC HTI-2 DSI alignment (where decision support applies)
Where verification crosses into clinical decision support, ONC's Health Data, Technology, and Interoperability rule DSI criteria apply.
05 · Governance & Compliance
Explainability / reason-code infrastructure
Saliency maps, per-feature contribution, and substitution rationale per decision — required for pharmacist review, dispute resolution, and audit.
05 · Governance & Compliance
Medication-safety committee reporting cadence
Verification miss rate, flag rate, override rate, and substitution override rate reported to medication-safety committee on published cadence.