Save team time
Model a 40% reduction in qualifying record work, then replace the estimate with your measured baseline.
FSMA 204 readiness for PCQI and food-safety teamsReview the records.
Review the records.
Assess the recall.
Determine and report.
Replace record-search scramble with a repeatable traceability workflow. TraceGuard AI helps your team find evidence faster, test recall response, and produce a defensible closeout package while keeping the final determination with your PCQI.
Built for readiness work. TraceGuard AI does not certify regulatory compliance.
Value you can measure
Recover time. Reallocate attention. Prove the process.
Start with your current hours and labor cost. Use disclosed planning assumptions before adoption, then replace the model with your own measured operational evidence.
Respond with evidence
Keep linked lot, supplier, shipment, customer, and document records ready for review and export.
Prepare for requests
Model record retrieval and evidence packaging separately using FDA workload research and a disclosed 50% planning reduction.
FDA's regulatory analysis explains that faster, more precise traceability can reduce the breadth and duration of recalls and withdrawals. This category-level finding is not a promise of TraceGuard AI customer savings. Review the FDA analysis.
One complete readiness loop
Review. Assess. Determine.
The product carries your team from the source records to the closeout report, so findings become documented actions instead of getting lost after a drill.
Review
Find the information
Bring suppliers, ingredients, lots, shipments, customers, and documents into one reviewable record trail.
Assess
Run the mock recall
Test the real process with a timer, backward and forward trace, volume reconciliation, outreach, and evidence review.
Determine
Close out the result
Give the PCQI the evidence to record the team's determination, assign findings and actions, sign, and export the report.
The deliverable
Finish with a report your team can review, sign, and act on.
TraceGuard AI turns the mock recall evidence into a structured closeout record. The software organizes the facts; your PCQI or authorized reviewer makes and signs the determination.
- A clear response timeline and lot scope
- Backward and forward trace evidence
- Volume reconciliation and quality review
- Findings, corrective actions, determination, and signature
TraceGuard AI
Mock Recall Report
Lot scope, evidence, and closeout
- Target lot
- Product and recall scope
- Response time
- Phase timestamps
- Trace evidence
- Supplier to customer
- Reconciliation
- Volumes and exceptions
- Quality review
- COAs and temperatures
- Outreach
- Requests and evidence
- Findings
- Actions and owners
- Determination
- PCQI sign-off
Verification ID and approval dateSupporting files included
Guided mock recall
A practiced process, not a scramble.
Run the same four-phase workflow every time and preserve the evidence behind the team's decision.
- Phase 01
Set the scope
Choose the target lot, define forward and backward trace scope, and start the response timer.
- Phase 02
Trace the lot
Connect supplier, ingredient, production, shipment, customer, and supporting-document evidence.
- Phase 03
Assess readiness
Reconcile volume, review COAs and temperatures, document outreach, and resolve evidence gaps.
- Phase 04
Determine and report
Record the PCQI determination, approve the closeout, and export the signed Mock Recall Report.
Supporting capabilities
The supporting tools stay connected to the readiness outcome.
Connected companies
Keep supplier and customer relationships attached to the lots and shipments they support.
COA tracking
Track Certificates of Analysis, requirements, temperatures, and quality evidence alongside the lot.
Faster record intake
Use FDA product search and AI-assisted document import to reduce manual entry, with human review before use.
Founding Customer Offer
Turn fewer record-search hours into more time for quality work.
Compare the subscription with your own operating baseline. Starter is $199 and Growth is $499 per month for the first 100 customers. The ROI calculator discloses its planning assumptions separately from price.
Starter
First 100 customersThe complete review, mock recall, determination, and reporting workflow for a single-site team.
$199/month
Switch to annual for a lower effective monthly cost.
Up to 5 users
- Records Library
- Manual record entry
- FDA product search
- Mock recall workflow
- Backward and Forward Trace
- Signed Mock Recall Report and evidence package
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Growth
Team PlanFirst 100 customersTeam recall operations with supplier follow-up, document tracking, and priority support.
$499/month
Switch to annual for a lower effective monthly cost.
Unlimited users
- Everything in Starter
- Advanced supplier outreach workflow
- Document status tracking
- Draft queue for team follow-up
- Priority support
- Guided setup recommended
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Plan Comparison
Starter covers the full readiness loop: review records, assess with a timed mock recall, record the PCQI determination, and export the report. Growth adds stronger team operations and support.
Need a business case? The ROI calculator shows recurring and FDA records-request estimates without assigning a value to compliance or recall risk.
| Capability | Starter | Growth |
|---|---|---|
| Best for | Single-site SMB food manufacturer | Recurring QA recall-readiness team |
| Users | Up to 5 | Unlimited |
| Records Library | Included | Included |
| Manual record entry | Included | Included |
| FDA product search | Included | Included |
| Mock recalls | Included | Included |
| Backward / Forward Trace | Included | Included |
| Audit-ready exports | Included | Included |
| Supplier outreach | Basic | Advanced workflow |
| Document tracking | Basic status | Full follow-up status |
| Support | Standard | Priority |
| Onboarding | Self-guided | Guided setup recommended |