Eliminate FDA 483 Observations, Warning Letters, and Consent Decrees in Medical Manufacturing.
Medical device and pharmaceutical manufacturing tolerates zero quality drift. TraceTrack automates Good Manufacturing Practices (cGMP) and 21 CFR Part 11 compliant audit trails.
The Downside of Ignoring FDA
FDA Warning Letters, product import alerts, product seizures, multi-million dollar consent decrees, and production halts.
Automated Operational Tracks for FDA
Use TraceTrack's 30-second Track Walk Builder and ambient voice AI to create, deploy, and execute:
How Trace AI Shields Your Facility.
Transform 500-page federal and international codes into ambient floor velocity and unassailable auditor proof.
The Expert Lens
Trace acts as a Medical Device Quality Assurance Director. It embeds ISO 13485 and 21 CFR 820 Quality System Regulations directly into frontline operations.
Instant Gap Analysis
Trace cross-references cleanrooms, packaging lines, and sterilizers against FDA medical device mandates, spotting uncalibrated gauges and skipped line clearances.
Auditor Walled Garden
Grant FDA investigators read-only access to an encrypted Walled Garden containing tamper-proof records with electronic signatures, biometric selfies, and exact timestamps.
Give auditors undeniable cryptographic proof of physical presence.
Create a Walled Garden that has specific hard bounds and hand it to your auditor. They don't need the app. It is cryptographically secure. It expires. This is the best way anyone has ever created to hand required data to their auditor. Sip a Diet Coke in your office instead of spending hours creating exports to hand to your auditor.
- Specific Hard Bounds: Select only the exact tracks, facilities, and date ranges they need to see—and absolutely nothing more.
- Zero user accounts or app required: Auditors open a secure, read-only guest link in any browser.
- Cryptographically sealed proof of presence: Frontline biometric selfies, GPS coordinates, and timestamped telemetry that auto-expire when the audit closes.
The Legacy Buzzword Translator
Frankenstein AI isn't the only trap legacy vendors are setting. Here is a quick translation guide for the rest of their corporate buzzwords, so you never pay for them again.
A chat window bolted onto a 10-year-old database that they charge you an extra $5,000 a year to use.
Per-seat extortion that forces your crew to share passwords, destroys your data integrity, and forces you to spend thousands of hours auditing a nightmare security rules matrix for everyone.
A guy they charge you $1,000/hr for because their software is too confusing to use out of the box.
A 15-step wizard that takes your manager three days to build a chart that only answers yesterday's questions.
No Hidden Fees or User Licenses.
No per-user fees. No locked modules. Unlimited team members forever.
Try TraceTrack totally unleashed for 3 days.
No credit cards required. No auto-billing traps.
Why a 3-day limit?
Starter Platform
First 2 LicensesIncludes your foundational 1 Site + 1 Workspace so your team can immediately build tracks and execute runs.
- Unlimited AI (No AI Credits)
- AI-led 5-Why Investigation
- Live Pit Wall Telemetry Feed
- Hands-Free Multilingual Voice Runs
- Andon TV Boards
- Walled Garden Auditor Links
- Real-time Frontline Triage Boards
- Cryptographic Selfie + GPS Seal
- Trace AI Conversational Analytics
Licenses 3–10
$300/month per license as you add more sites or departments.
- Unlimited AI (No AI Credits)
- AI-led 5-Why Investigation
- Live Pit Wall Telemetry Feed
- Hands-Free Multilingual Voice Runs
- Andon TV Boards
- Walled Garden Auditor Links
- Real-time Frontline Triage Boards
- Cryptographic Selfie + GPS Seal
- Trace AI Conversational Analytics
Licenses 11+
$250/month per license for multi-facility operations.
- Unlimited AI (No AI Credits)
- AI-led 5-Why Investigation
- Live Pit Wall Telemetry Feed
- Hands-Free Multilingual Voice Runs
- Andon TV Boards
- Walled Garden Auditor Links
- Real-time Frontline Triage Boards
- Cryptographic Selfie + GPS Seal
- Trace AI Conversational Analytics
How TraceTrack Licensing Works
Every license powers a single node in your operation: a Site (physical facility), or a Workspace (department or line).
Starter Platform ($350/month)
Includes your first 2 licenses—locking in your foundational 1 Site + 1 Workspace so your team can immediately build tracks and execute runs.
Licenses 3–10
$300/month per license as you add more sites or departments.
Licenses 11+
$250/month per license for multi-facility operations.
Always includes unlimited guest runs, kiosk execution, and zero per-seat fees.
No artificial boundaries. Connect operators, supervisors, and outside auditors at zero extra cost.
Explore Other Regulatory Frameworks
TraceTrack natively covers every major frontline compliance and safety standard.
Ready to Audit-Proof Your Operations for FDA?
Deploy FDA across your physical plant floor in under 120 seconds. Zero per-seat fees. Unlimited operators. 100% hands-free voice execution.