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Safety Regulation Provisions for Simulation-Based Evidence

30 Chapters
View Course Samples Online
01
Regulatory landscape for simulation-based evidence
key provisions, scope, and applicability across safety-critical industries.
Regulatorylandscape
02
Foundational concepts
verification, validation, and accreditation (VV&A) terminology and their regulatory definitions.
Foundationalverification
03
Simulation credibility framework
ASME V&V 10/20/40, NASA-STD-7009, and FDA guidance for model-informed drug development.
Simulationcredibility
04
Evidence hierarchy and admissibility
how simulation evidence is weighted against physical test and operational data.
Evidencehierarchy
05
Model development lifecycle under regulatory scrutiny
requirements capture, design, implementation, and configuration management.
developmentlifecycle
06
Verification provisions
code verification, solution verification, and software quality assurance evidence.
Verificationprovisions
07
Validation provisions
experimental design, data quality, and statistical comparison to reference data.
Validationprovisions
08
Uncertainty quantification (UQ) requirements
aleatory and epistemic uncertainty, sensitivity analysis, and propagation methods.
Uncertaintyquantification
09
Credibility assessment and maturity levels
applying the Predictive Capability Maturity Model (PCMM) and credibility evidence matrix.
Credibilityassessment
10
Documentation and traceability
regulatory submission packages, evidence logs, and audit-ready records.
Documentationtraceability
11
Independent review and peer assessment
roles, independence criteria, and review board composition.
Independentassessment
12
Qualification and certification of simulation tools
tool validation, version control, and regression testing.
Qualificationcertification
13
Data governance for simulation evidence
provenance, integrity, security, and retention requirements.
governancesimulation
14
Regulatory acceptance criteria
thresholds, acceptance sampling, and decision rules for simulation-based submissions.
Regulatoryacceptance
15
Case study
nuclear safety analysis and 10 CFR 50.46 Appendix B simulation evidence requirements.
analysisCFR
16
Case study
medical device modeling and FDA's draft guidance on computational modeling evidence.
modelingFDA
17
Case study
aerospace certification and FAA/EASA acceptance of simulation for compliance finding.
aerospacecertification
18
Case study
automotive safety and ISO 26262 / SOTIF simulation evidence provisions.
automotiveISO
19
Cross-industry harmonization
ASME V&V 40, FDA, and EMA model-informed drug development pathways.
Cross-industryharmonization
20
Risk-informed decision-making
integrating simulation evidence into probabilistic risk assessment and safety cases.
Risk-informeddecision-making
21
Regulatory audit and inspection readiness
common findings, corrective actions, and evidence gap analysis.
Regulatoryinspection
22
Simulation evidence in support of design certification
digital twins, virtual testing, and regulatory sandboxes.
Simulationevidence
23
Machine learning and AI-enabled simulation
regulatory provisions for data-driven models and explainability.
AI-enabledsimulation
24
Cloud and high-performance computing environments
compliance, reproducibility, and data sovereignty.
high-performancecomputing
25
Practical workshop
building a credibility evidence matrix for a representative safety-critical simulation.
workshopbuilding
26
Practical workshop
drafting a validation plan and UQ report for regulatory submission.
workshopdrafting
27
Practical workshop
conducting an independent review and documenting findings.
workshopconducting
28
Practical workshop
preparing an audit-ready evidence package and traceability matrix.
workshoppreparing
29
Emerging trends
regulatory science research, standardization efforts, and international mutual recognition.
Emergingregulatory
30
Capstone project
end-to-end development and defense of a simulation-based evidence package for a chosen safety application.
Capstoneend-to-end