Solution Briefs

Operational workflows for regulated evidence review

Each brief describes a specific compliance workflow, the operational trigger, and how Tiebreaker AI structures evidence to support faster, clearer decisions.

Example Assessment View
Requirement AreaCoverage Status
🏢
Company Information
Registration and ownership
✓Well Covered
💰
Financial Stability
Financial health and continuity
✓Well Covered
⚙️
Quality Management
QMS documentation
−Partially Covered
📋
Regulatory Compliance
Licenses and certifications
✕Not Covered
🔒
Information Security
Security policies and controls
✓Well Covered
Readiness Score
72%

Supplier Verification

Supplier Verification Readiness

Structure supplier documentation review against selected frameworks. Surface gaps before procurement approval.

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Example Assessment View
Requirement AreaCoverage Status
🏥
ISO 13485
Medical device QMS
✓Well Covered
🔐
SOC 2
Trust service criteria
✓Well Covered
📄
21 CFR Part 820
Quality system regulation
−Partially Covered
🔁
CAPA
Corrective actions
✕Not Covered
📦
Supplier Management
Supplier controls
✓Well Covered
Readiness Score
71%

Framework Alignment

Multi-Framework Alignment

See how evidence aligns across multiple frameworks without redundant review.

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Example Assessment View
Requirement AreaCoverage Status
🔒
Information Security
Policies and safeguards
✓Well Covered
👥
Privacy & Data Handling
Data use and retention
−Partially Covered
💼
Financial Stability
Health and continuity
✓Well Covered
⚖️
Regulatory Compliance
Licenses and legal obligations
−Partially Covered
🚨
Incident & Breach
Response documentation
✕Not Covered
Readiness Score
68%

Third-Party Risk

Third-Party Risk Assessment Readiness

Streamline third-party risk reviews with structured evidence mapping and clear coverage visibility.

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Example Assessment View
Requirement AreaCoverage Status
👤
Management Responsibility
Leadership and quality policy
✓Well Covered
⚙️
Design Controls
Design and development process
✓Well Covered
🔁
CAPA (820.100)
Corrective and preventive action
−Partially Covered
📄
Document Controls
Document management system
✓Well Covered
📦
Purchasing Controls
Supplier qualification
✕Not Covered
Readiness Score
68%

Medical Devices

FDA 21 CFR Part 820 Evidence Review

Map device manufacturer and supplier documentation against Quality System Regulation requirements.

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Example Assessment View
Requirement AreaCoverage Status
⚙️
Quality Management
QMS scope and policies
✓Well Covered
⚠️
Risk Management
Risk assessment and controls
✓Well Covered
🎨
Design Controls
Design control documentation
−Partially Covered
🔁
CAPA Management
Corrective and preventive action
✕Not Covered
📦
Supplier Controls
Supplier qualification records
✓Well Covered
Readiness Score
66%

Medical Devices

ISO 13485 Supplier Documentation Workflow

Map supplier qualification documentation to ISO 13485 supplier control requirements by control area.

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Example Assessment View
Requirement AreaCoverage Status
🔒
Security Policy
Policies and technical controls
✓Well Covered
🔑
Access Control
User access management
✓Well Covered
🚨
Incident Response
Incident handling procedures
✕Not Covered
🔐
Encryption at Rest
Data encryption controls
−Partially Covered
📦
Vendor Management
Third-party oversight
✓Well Covered
Readiness Score
64%

Vendor Risk

SOC 2 Vendor Intake Review

Review vendor SOC 2 reports and policies against internal control requirements. Surface gaps before onboarding.

View solution brief
Example Assessment View
Requirement AreaCoverage Status
📜
Export License
Export authorization
✓Well Covered
🌐
Country of Origin
Origin certification
✓Well Covered
🏅
Product Certifications
Regional product compliance
−Partially Covered
📦
Customs Documentation
Customs and tariff records
✕Not Covered
⚖️
Sanctions Screening
Restricted party review
✓Well Covered
Readiness Score
70%

Global Trade

Cross-Border Supplier Verification

Validate supplier compliance for global trade and regulatory requirements across different regions.

Coming soon
Example Assessment View
Requirement AreaCoverage Status
⚖️
Code of Conduct
Ethics and conduct standards
✓Well Covered
🔒
Data Privacy Policy
Data handling and privacy
−Partially Covered
🛡️
Information Security
Security policy framework
✓Well Covered
📦
Supplier Policy
Supplier governance standards
✕Not Covered
📋
Records Retention
Retention schedules and policy
✓Well Covered
Readiness Score
62%

Policy Governance

Internal Policy Mapping

Align internal policies with external frameworks for stronger governance and easier audits.

Coming soon

New Solution Briefs are continuously being added across additional frameworks, supplier workflows, and regulated operational environments.

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Select a framework and upload a redacted document set to explore the workflow.

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📅

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