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Hierarchical Process Architecture For Regulatory Verification

Straits transforms thousands of disconnected regulatory requirements into an intuitive, deterministic tree structure. Every regulation, clause, and engineering artifact connects directly to a verified cryptographic source of truth.

Process Tree Architecture • Non-Editable Showcase

Live Attestation Tree Flowchart

Visualizing hierarchical parent-child relationships from Master Quality Plan down to individual clause artifacts.

Full Web App
ROOT NODE100% Tree Health
Enterprise Quality & Compliance Master Plan

Unified Root Attestation Anchor • Multi-Framework Harmonization Engine

SHA-256: 8f2a9c...3d1b•Cryptographically Sealed
BRANCH 0118 Clauses Linked
ISO 13485:2016 Medical Devices QMS

Target Quality Management System mapped to FDA 21 CFR Part 820 requirements.

Clause 7.3 • Design Verification100% Validated
Artifact: fmea_revB.pdf4.2 MB
Clause 8.2 • CAPA ProtocolAttested
Artifact: CAPA-2026-004Signed
BRANCH 02Class B Software
IEC 62304 Medical Device Software

Software life-cycle processes, automated unit testing, and continuous CI/CD traceability.

Section 5.1 • Software PlanningCI/CD Linked
Pipeline: GitHub ActionsBuild #1429
Section 5.5 • Integration TestingPassed
Telemetry: Coverage99.4% Verified
BRANCH 03Continuous Attestation
SOC 2 Type II Security Controls

Automated trust services criteria for security, availability, and confidentiality.

CC6.1 • Zero-Trust AccessEnforced
IAM Sync: Okta / RBACActive
CC7.2 • Vulnerability ScanningCleared
Scanner: 0 Critical CVEsPassed
Tree Verification Status:All 3 Branches Attested • 0 Non-Conformances Detected
Deterministic Flowchart Model • Straits Smart Editor
CAPABILITY 01 • PROCESS MODELING

Modular Multi-Level Tree Modeling

Deconstruct complex compliance workflows into modular trees with unlimited hierarchical depth. Every process node maintains bidirectional references to regulatory clauses and design history.

Unlimited parent-child tree recursion with auto-balancing
Reusable process blocks synchronized across audit cycles
Bidirectional hyperlinking between procedures and standards
Hierarchical Tree Explorer
Click node to inspect
Node PropertiesInteractive Live Inspector
Selected Node
ISO 14971 Risk Analysis (FMEA)
Parent Anchor
ROOT → Design Controls (§7.3)
Linked Artifacts
FMEA_Risk_Table_Rev3.pdfSHA-256 Valid
Status: Complete0 Unresolved Gaps
Dynamic Clause Checklist & Evidence Vault

Click checkmarks to verify completion

3 of 4 Verified
ISO 13485 §7.3.3
Design Input Requirements & User Need Traceability
1.8 MB
FDA 21 CFR 820.30(f)
Design Verification Protocol & Benchtop Test Logs
4.2 MB
IEC 62304 §5.5
Automated Software Unit & Integration Coverage Report
820 KB
EU MDR Annex II §4
Post-Market Surveillance & Vigilance Plan
2.1 MB
Dossier Completion Index75% Complete
CAPABILITY 02 • DOCUMENTATION & CHECKLISTS

Dynamic Checklists & Evidence Vault

Attach rich verification evidence directly to process nodes. Generate context-aware checklists tailored to target certification frameworks, with full audit trail history.

Automatic questionnaire generation based on active standards
Cryptographic document sealing with immutable revision logs
AI-powered full-text semantic search across complete dossiers
CAPABILITY 03 • COMPLIANCE MAPPING

Cross-Standard Harmonization & Gap Detection

Map common operational procedures simultaneously across ISO, FDA, SOC 2, and EU MDR. Real-time coverage analytics eliminate redundant documentation and pinpoint regulatory blind spots.

Single procedure fulfills multiple regulatory requirements
Automated clause diff detection across revised standards
Immutable tamper-proof audit trail for regulatory inspectors
Regulatory Framework Coverage Index
98.4% Overall Harmonization
ISO 13485:2016 (Medical Devices)18/18 Clauses (100%)
FDA 21 CFR Part 820 (QMSR)24/25 Clauses (96%)
EU MDR 2017/745 (Annex I GSPR)31/32 Clauses (97%)
SOC 2 Type II (Security Controls)14/14 Clauses (100%)
Harmonization Insight: Section 7.3 design verification artifacts automatically satisfied FDA 820.30(f) and EU MDR GSPR 17.2 with zero duplicate documentation.
Live Collaborative Audit Session
3 Reviewers Active
Dr. Sarah ChenLead Auditor
Alex RiveraQA Director
Straits AI Assistant
Straits AI Recommendation Engine
Clause §8.5.2

Notice: Your CAPA protocol in Section 8.2 references an outdated SOP (v2.1). Recommend updating citation to SOP-QA-089 v3.0 to maintain ISO 13485 §8.5.2 alignment.

10:42 AM: Dr. Sarah Chen approved ISO 14971 Risk VerificationSigned
10:45 AM: AI Assistant auto-mapped 4 GitHub CI pull requestsSynced
CAPABILITY 04 • COLLABORATION & AI

Real-Time Auditor Mesh & AI Copilot

Empower regulatory consultants, internal QA engineers, and external Notified Body auditors to review live dossiers simultaneously. Intelligent AI assistants proactively flag discrepancies before inspectors do.

Multi-user simultaneous editing with presence tracking
Intelligent gap identification and clause remediation prompts
Automated auditor workload balancing and task queues
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