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Big Picture

Regulated Environments

Organizations in regulated industries operate under strict compliance requirements that affect how software is deployed, updated, and licensed. These requirements vary by industry and jurisdiction but share common themes around audit trails, data privacy, security controls, and operational governance.

Big Picture addresses regulatory requirements through consistent capabilities that work across different regulatory frameworks: comprehensive audit trails, vendor-controlled mirrors, local license servers, cryptographic signing, and policy-driven update governance.

When This Guidance Applies

Section titled “When This Guidance Applies”

This guidance applies when you ship software to:

  • Healthcare organizations subject to HIPAA or similar regulations
  • Financial institutions subject to SOX, PCI-DSS, or banking regulations
  • Government agencies requiring FedRAMP compliance or security clearances
  • Organizations in other regulated industries with strict compliance requirements

Regulated customers typically require strict controls over software updates, comprehensive audit trails, self-hosted infrastructure options, and the ability to operate within their own network boundaries.

Common Regulatory Themes

Section titled “Common Regulatory Themes”

Regulated industries share common requirements that Big Picture addresses:

  • Audit trails: Comprehensive logs that document all system activity for compliance reporting
  • Data privacy: Minimal data collection and support for local operation within organizational boundaries
  • Security controls: Cryptographic signing, role-based access control, and secure key management
  • Self-hosted operation: Vendor-controlled mirrors and local license servers that operate within organizational networks
  • Policy governance: Explicit policy controls that respect organizational requirements and change management processes

These capabilities reduce compliance complexity by providing consistent mechanisms that work across different regulatory frameworks.

Industry-Specific Guidance

Section titled “Industry-Specific Guidance”

  • Healthcare Environments Guidance for shipping software into healthcare and HIPAA-regulated environments. Covers HIPAA compliance requirements, clinical environment constraints, and operational considerations for healthcare IT systems.

  • Financial Services Guidance for shipping software into banks and financial institutions. Addresses SOC2 requirements, SOX compliance, PCI-DSS considerations, and banking IT controls.

  • Government and Public Sector Guidance for shipping software into government and public sector environments. Covers FedRAMP compliance, air-gapped deployment, security clearance requirements, and government IT controls.

  • Common Regulatory Requirements Overview of shared regulatory themes across industries and how Big Picture addresses them. Covers audit trails, data privacy, security controls, vendor-controlled mirrors, and local license server deployment.

Key Capabilities for Regulated Environments

Section titled “Key Capabilities for Regulated Environments”

Self-Hosted Infrastructure

Section titled “Self-Hosted Infrastructure”

Regulated environments often require software to operate within organizational network boundaries. Big Picture supports:

  • Vendor-controlled mirrors that allow organizations to host updates within their networks
  • Local license servers that operate independently of cloud infrastructure
  • Air-gapped operation for sensitive systems
  • Outbound-only operation that doesn’t require inbound firewall rules

Comprehensive Audit Trails

Section titled “Comprehensive Audit Trails”

Regulated organizations must maintain audit logs and demonstrate compliance. Big Picture provides:

  • Detailed logs of license usage, update decisions, and policy changes
  • Timestamped records with user context for all administrative actions
  • Exportable logs that integrate with compliance and audit systems
  • Signed update metadata that provides cryptographic proof of update sources

Security and Access Controls

Section titled “Security and Access Controls”

Regulated environments require strict security controls. Big Picture provides:

  • Cryptographic signing of all update decisions and license leases
  • Role-based access control for administrative functions
  • Secure key management for signing and license operations
  • Local signature verification that doesn’t require network access

Policy-Driven Governance

Section titled “Policy-Driven Governance”

Regulated environments require operational governance over software updates. Big Picture supports:

  • Explicit update policies that respect organizational requirements
  • Version pinning and staged rollouts
  • Change management integration
  • Emergency update procedures for security patches

Next Steps

Section titled “Next Steps”