Enterprise Governance

Compliance Ready

Built for Accuracy, Trust, and Regulated Content

SatelliteAI is designed for teams where accuracy matters—from fast-moving marketing organizations to highly regulated industries. Our governance, verification, and audit capabilities support regulated content workflows without slowing down operations.

Accurate before it ships
Traceable after it ships
Auditable when it matters
Governed at scale
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Why Compliance Now Matters for Search and Content

AI-era search changes the risk profile of published content. When answer systems summarize and cite content directly, a single unverified claim can create significant exposure.

That is why SatelliteAI pairs SEO and AEO optimization with verification-first governance.

  • Amplification risk: Claims can be repeated across multiple AI interfaces
  • Context loss: Content may be cited without original context or caveats
  • Brand and legal risk: Unverified claims create exposure in regulated environments
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Verification-First Governance

Content is verified before it ships, traceable after it ships, and auditable when regulators or quality teams require evidence.

U.S. FDA

Code of Federal Regulations Title 21

Regulated organizations often need controls that support labeling, claims, record integrity, and controlled processes.

21 CFR Part 801

Device Labeling

General device labeling requirements for medical devices.

  • Claims and labeling routed through approval workflows
  • Page-level edits tracked with version history
  • Claim validation logic to reduce over-claiming
21 CFR Part 809

In Vitro Diagnostics

Labeling considerations for IVD products including limitations and intended use.

  • Structured claims libraries and controlled language
  • Review workflows to reduce statement drift
  • Audit-ready traceability of changes and approvals
21 CFR Part 812

Investigational Device Exemptions

Additional controls for investigational-use materials and separation from commercial claims.

  • Permission-based publishing controls
  • Review gates preventing unauthorized promotion
  • Audit logs for regulated content changes
21 CFR Part 820

Quality System Regulation

Requirements for manufacturers of finished medical devices. Includes QMSR transition incorporating ISO 13485:2016.

  • Repeatable, controlled content workflows
  • Audit trails for inspection-style traceability
  • Governance aligned with process control expectations

21 CFR Part 11 Support

Electronic Records and Electronic Signatures

21 CFR Part 11 addresses criteria under which FDA considers electronic records and electronic signatures trustworthy, reliable, and equivalent to paper records and handwritten signatures.

  • E-signature support for approvals (who signed, what, when)
  • Immutable audit trails for regulated actions
  • Role-based access controls for separation of duties
  • Versioning and record retention patterns
Part 11 applicability depends on your specific use case and predicate rules. Many organizations use Part 11-aligned controls even when not strictly required.

Part 11-Aligned Controls

Trustworthy, reliable, equivalent

E-Signatures
Immutable Audit Trails
Role-Based Access
Version Control
European Union

EU MDR Considerations

Medical Device Regulation (EU) 2017/745 establishes requirements for safety, performance, clinical evidence, labeling, and post-market surveillance.

Technical Documentation

Content change tracking across versions and publishing events. Links between claims, evidence references, and page updates.

Lifecycle Maintenance

Workflow structure designed to support audit and review readiness throughout the device lifecycle.

Post-Market Surveillance

Governance controls supporting regulated content review with traceability of changes and approvals.

Capabilities

Governance, Verification, and Audit Readiness

SatelliteAI's compliance-ready posture is built on three layers that work together to support regulated content workflows.

1

Governance

Controls to manage how content is created, reviewed, and published.

  • Role-based permissions and approvals
  • Structured review stages
  • Publish gates and controlled change management
2

Verification

Controls to reduce incorrect or unverifiable content.

  • Claim validation logic
  • Evidence grounding and source traceability
  • Verification-first reasoning for high-risk recommendations
3

Auditability

Controls to reconstruct what happened, when, and by whom.

  • Full audit trails for key actions
  • Version history and change diffs
  • E-signature support for approval events
Outcomes

What This Enables for Regulated Teams

Marketing and content teams move faster while regulatory and quality stakeholders maintain confidence that outputs remain controlled and defensible.

Reduce Unverified Claims

Catch errors before publication, not after

Clear Change Records

Maintain audit trails for reviews and inspections

Scale Without Sacrificing Oversight

Grow content operations while maintaining control

Align SEO with Governance

Optimization within compliance constraints

FAQ

Frequently Asked Questions

SatelliteAI supports Part 11-aligned controls such as audit trails, e-signatures, and role-based access. Part 11 compliance depends on your organization's validation approach and specific predicate rule requirements.
No. SatelliteAI is designed to integrate into your existing quality and regulatory processes by supporting controlled workflows, traceability, and approval evidence.
SatelliteAI supports governed content creation, traceability, and change control that align with MDR expectations for lifecycle documentation maintenance and post-market surveillance artifacts.
SatelliteAI serves teams where accuracy matters—from life sciences and medical devices to financial services and any organization where content claims carry regulatory or brand risk. Our governance features scale from fast-moving marketing teams to highly regulated enterprise environments.

Compliance Is Operational Discipline

SatelliteAI helps teams maintain that discipline while adapting to AI-era search, where content is increasingly summarized, cited, and reused outside of its original context.

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Accuracy, traceability, and governance are now part of search visibility.