This platform contains proprietary regulatory intelligence workflows, audit systems, CAPA processes,
AI-assisted compliance tooling, and confidential operational logic.
Unauthorized use, duplication, redistribution, reverse engineering, commercialization, or disclosure
of this platform, in whole or in part, is strictly prohibited. Access is authorized only for approved
evaluation or internal use.
AI-generated outputs are decision-support tools only and do not replace professional QA/RA judgment.
Audit data may contain confidential compliance information.
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Authorized Users Only — Session Protected
Default admin: admin / Admin2026!
Change credentials in Settings → User Management after first login.
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No audit history yet. Create your first audit under New Audit.
⚕ CAPA Workflow
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🔴 Open & Overdue
📋 All CAPAs
📊 CAPA Analytics
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FDA Last Checked
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● UNKNOWN
ISO Last Checked
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● LIVE
EU MDR Last Checked
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● LIVE
Clinical Trials Last Checked
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● UNKNOWN
🔔 REGULATORY UPDATES
Click a button above to load regulatory updates.
💌 Subscribe to Regulatory Alerts
⚠ Alerts
Click Load Alerts to see high-risk regulatory events.
📊 Analytics
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🤖 AI Regulatory Intelligence
⚠ AI Governance Notice: Scores and predictions are generated by statistical models applied to your QMS data. They are decision-support tools only — final regulatory judgement must be made by qualified QA/RA professionals.
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🤖 AI Copilot
⚠ AI Governance Notice: This AI Copilot provides decision-support only, based on rule-based analysis of your QMS data. Final QA/RA judgment is required before taking any regulatory action.
Select an analysis above, or click AI Analyze on any Audit or CAPA card.
📚 Documents
📄
Drop PDF here or click to upload
PDF files only · Max 4 MB · Stored locally in browser
0 Documents
No documents uploaded yet. Upload a PDF above to get started.
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Select a document to view it here
Click 👁 to open a PDF · 🔗 to link to an audit finding
🔗 Records & Traceability
Enterprise record registry with sequential IDs, folder scaffold, and cross-module traceability links. Every Clinical Analysis, CAPA, Audit, and Regulatory Event is automatically assigned a traceable ID.
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Record ID
Module
Title
Status
Created
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🔗 Link Records
📝 Electronic Signature
Approval Signature — 21 CFR Part 11 compliant
⚠ By signing, you certify that this record meets all applicable requirements and that your electronic signature is the legally binding equivalent of your handwritten signature under 21 CFR Part 11.200. This action is logged immutably with timestamp, IP address, and a cryptographic hash.
⚙ Settings
👤 User Management
Manage platform users and role-based access permissions.
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💾 Backup & Restore
Full database snapshots with SHA-256 checksum verification. Daily auto-backup runs at 02:00 UTC.
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⚠ Restore Database
Restoring will overwrite all current data with the selected backup.
Confirm your admin credentials to proceed.
Restoring:
SystemAUDIVION Clean Build
Data SourcesFDA, ISO, EU MDR
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AI EnrichmentOpenAI GPT-3.5-turbo — rate limited, cached
VersionAUDIVION v5.2 — Production Architecture
🔒 Production Architecture Status
⏱
Rate Limiter
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100 calls / user / hour
ACTIVE
⚡
Response Cache
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TTL: 1 hour — deduplicates OpenAI calls
ACTIVE
🔒
Input Validation
All API inputs sanitised
Max 5000 chars · severity allow-list · XSS clean
ACTIVE
📋
21 CFR Part 11 Audit Trail
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Every AI call, cache event & server start logged
ACTIVE
⏱ Rate Limit Usage (this session)
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🤖 AI Analysis Log (persistent — all users)
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📋 21 CFR Part 11 Audit Trail
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📧 Email Providers
Configure SMTP credentials for sending regulatory alert emails. Credentials are AES-256 encrypted before storage.
No email providers configured. Click + Add Provider to set one up.
📧 Add Email Provider
Quick Setup — Select Provider:
Gmail & Yahoo require a 16-character App Password — not your regular login password.
Outlook/Office365 use your regular password.
SendGrid/Mailgun: use your API key (username = apikey).
💌 My Subscriptions
Enter your email above to view subscriptions.
🚀 Data Management
📋 Load Audit Findings — AUD-2026-0001 (F-002 to F-008)
Seeds the 7 remaining findings from the 03_Audit_Findings_Report into Audit History, linked to parent audit AUD-2026-0001.
Finding details, root causes, containment, and corrective actions are populated from the report.
Also creates CAPA records for all CRITICAL and MAJOR findings (F-002 through F-006).
If AUD-2026-0001 is already saved, company, device, and auditor data is inherited automatically.
🔬 Clinical Analysis
Upload clinical documents and let AI analyze them against ISO 14971, ISO 13485, FDA guidance, and EU MDR clinical evidence requirements.
📄 Clinical Documents
📋
Click or drag & drop PDF Clinical trials, study protocols, post-market data
📑
Click or drag & drop PDF CER, PMCF reports, literature reviews
🏥 Device Information
📋 Analysis Standards
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📋 Saved Analyses
No saved analyses yet. Run your first clinical analysis above.
🔬 Clinical Analysis Results
Running analysis...
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Running analysis...
Running analysis...
⚠ AI-generated analysis is a decision-support tool only. QA/RA professional judgment is required before use in any regulatory submission.
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New Audit
Record audit notes, findings, and observations. Saved locally in your browser and retrievable from Audit History.
Regulatory Monitor
Fetch live regulatory intelligence from FDA, ISO, and EU MDR sources. Use Check FDA / ISO / EU MDR to filter by source, or Refresh All to load everything.
Alerts
Displays only CRITICAL and HIGH severity events for immediate attention.
Analytics
Summary metrics: total events, critical count, risk breakdown by source.
⚠
Description
Affected Device(s)
Recommended Action
🔒
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