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Model Requalification After Design and Solver Changes

30 Chapters
View Course Samples Online
01
Course overview
scope, regulatory context, and the requalification lifecycle for models affected by design or solver changes.
regulatoryrequalification
02
Change classification
distinguishing design changes from solver changes, and their impact on model validity and qualification status.
classificationdistinguishing
03
Regulatory and quality frameworks
applicable standards (e.g., FDA, EMA, ISO) and internal SOPs governing model requalification.
Regulatoryframeworks
04
Model inventory and change impact assessment
identifying affected models, dependencies, and criticality for requalification prioritization.
inventoryassessment
05
Design change documentation
capturing change rationale, version control, and traceability for requalification evidence.
documentationcapturing
06
Solver change characterization
understanding numerical method updates, solver version changes, and their potential effects on simulation results.
characterizationunderstanding
07
Risk assessment for requalification
applying risk-based approaches to determine the extent of requalification testing.
assessmentrequalification
08
Requalification planning
defining scope, acceptance criteria, resources, and timelines in a requalification plan.
Requalificationplanning
09
Test case selection and design
choosing representative and edge-case scenarios to verify model performance after changes.
selectionchoosing
10
Reference data and benchmarks
establishing or updating reference datasets for regression testing and solver verification.
Referencebenchmarks
11
Regression testing execution
running automated and manual tests, capturing results, and comparing against baseline.
Regressionexecution
12
Statistical analysis of requalification results
equivalence testing, tolerance intervals, and acceptance sampling.
Statisticalanalysis
13
Handling deviations and failures
investigation, root cause analysis, and corrective actions during requalification.
Handlingdeviations
14
Solver verification and validation
confirming solver accuracy, stability, and convergence after updates.
verificationvalidation
15
Design change verification
ensuring model geometry, materials, and boundary conditions reflect the design change correctly.
verificationensuring
16
Model documentation updates
revising model reports, specifications, and user guides to reflect requalification outcomes.
documentationrevising
17
Change control and approval workflow
routing requalification evidence through quality systems and obtaining sign-off.
approvalworkflow
18
Case study
requalification after a CAD design change in a structural model.
requalificationCAD
19
Case study
requalification after a solver upgrade in a computational fluid dynamics model.
requalificationcomputational
20
Case study
combined design and solver change in a multiphysics model.
combinedmultiphysics
21
Automation and tooling
scripting regression tests, managing test suites, and integrating with CI/CD pipelines.
Automationscripting
22
Data integrity and audit trails
ensuring ALCOA+ principles in requalification records and electronic signatures.
integrityensuring
23
Training and competency
preparing users for new solver versions and updated model workflows.
Trainingcompetency
24
Communication and stakeholder management
reporting requalification status to project teams and regulators.
Communicationstakeholder
25
Post-requalification monitoring
ongoing performance tracking and periodic review to maintain qualified state.
Post-requalificationmonitoring
26
Common pitfalls and lessons learned
avoiding scope creep, insufficient testing, and documentation gaps.
pitfallsavoiding
27
Regulatory submission considerations
presenting requalification evidence in filings and inspections.
Regulatorysubmission
28
Integrating requalification with model lifecycle management
linking to version control, change logs, and retirement.
Integratingrequalification
29
Future trends
machine learning-assisted regression testing, cloud-based solvers, and continuous qualification.
learning-assistedregression
30
Capstone project
develop a complete requalification plan and execute a mock requalification for a representative model.
Capstonecomplete