Regulatory Compliance
Generate regulatory-compliant simulation reports for ASME, AS9100, DO-178C, and FDA.
SimPilot includes pre-built compliance templates for generating simulation reports that meet industry regulatory standards. Each template enforces the required sections, formatting, evidence requirements, and approval chains for its respective standard.
Compliance templates
ASME V&V-40 -- Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices.
Required sections:
- Question of interest and context of use
- Model risk assessment (consequence of incorrect prediction)
- Verification activities (code verification, calculation verification, mesh convergence)
- Validation activities (comparison with experimental/clinical data)
- Uncertainty quantification
- Applicability and limitations
- Credibility assessment summary
Use this template for medical device simulations where computational modeling supports regulatory submissions.
AS9100 -- Quality Management Systems for Aviation, Space, and Defense.
Required sections:
- Simulation scope and objectives
- Configuration management (software versions, solver settings, mesh parameters)
- Validation evidence (test correlation, mesh independence)
- Non-conformance and corrective actions
- Traceability matrix (requirements to simulation results)
- Approval chain with role-based signatures
Use this template for aerospace quality management documentation.
DO-178C -- Software Considerations in Airborne Systems and Equipment Certification.
Required sections:
- Software (solver) identification and version
- Verification objectives and methods
- Test cases and expected results
- Structural coverage analysis
- Problem reports and resolution
- Configuration index
- Compliance matrix
Use this template when simulation software or results feed into aviation certification processes.
FDA Simulation Report -- Computational Modeling and Simulation submissions.
Required sections:
- Device description and intended use
- Computational model description
- Verification and validation summary
- Sensitivity and uncertainty analysis
- Clinical relevance assessment
- Model limitations and applicability domain
Use this template for FDA pre-market submissions involving computational evidence.
Generating a compliance report
Select the template
Choose the applicable regulatory standard when generating a report. The template determines the required sections and formatting.
Auto-populated sections
SimPilot automatically fills sections from your project's validation record: simulation setup, mesh convergence data, solver versions, boundary conditions, and results. Acceptance criteria and evidence are pulled from the validation framework.
Review and complete
Some sections require manual input -- engineering judgment, clinical relevance statements, or risk assessments that the AI cannot determine. These are highlighted for your attention.
Approval chain
Route the report through the required approval chain. Each approver signs off on their section, and the complete approval history is embedded in the final document.
Compliance evidence export
Export all validation evidence for a project in a single package:
- Simulation setup and configuration files
- Mesh convergence study results
- Validation comparison data (simulation vs. experimental)
- Auto-validation check results
- Review history and approval records
- Complete revision history with diffs
The evidence export bundles everything an auditor needs into a single downloadable archive. No manual gathering of files from different locations.
Audit trail
Every action in SimPilot is logged for regulatory traceability:
- Case creation, modification, and deletion timestamps
- Who made each change and what was changed
- Review submissions, decisions, and comments
- Report generation and approval events
- Evidence attachment and removal
The audit trail is immutable -- entries cannot be edited or deleted after creation. This satisfies traceability requirements across all supported regulatory frameworks.