TraceGuard AI

Make the value measurable before you buy

Start with the workload and labor cost your team knows today. TraceGuard applies disclosed 40% recurring-work and 50% FDA records-request planning assumptions while keeping regulatory and recall risk separate.

Your operating baseline

Estimate recurring and event value

Enter what your team knows today. TraceGuard applies two disclosed planning assumptions so you do not have to predict a future workflow you have not experienced.

40%

BAU time reduction

Applied only to qualifying manual traceability-record work.

50%

FDA request reduction

Applied to a 16-hour planning midpoint.

Include time spent locating, checking, cross-referencing, reconciling, following up on, and packaging traceability records. Exclude production work, regulatory judgment, investigations, remediation, and training.

Your estimate

Disclosed planning assumptions

Add your current qualifying workload and labor cost. The result will apply a 40% BAU reduction and show a separate 50% FDA records-request estimate.

These are planning estimates, not guaranteed savings or measured customer averages. The FDA estimate concerns formatting certain requested traceability information, not the duration of a complete inspection, investigation, audit, or recall. Actual results depend on record volume, process maturity, data quality, staffing, adoption, and supply-chain coordination. This calculator excludes recall losses, penalties, legal exposure, revenue impact, and other risk costs. TraceGuard AI does not guarantee savings, compliance, or recall prevention.

Evidence, with scope

Why speed and defensible records matter

These FDA sources establish the category-level urgency. They do not establish TraceGuard AI customer savings or guarantee an outcome.

Record response

FDA says covered records generally must be provided within 24 hours of a request, or within another reasonable time agreed to by FDA.

Timing and applicability depend on the request, the rule, and the organization. TraceGuard AI does not determine compliance.

FDA Food Traceability Rule FAQ

Records-request workload

FDA estimated that formatting certain requested traceability information into an electronic sortable spreadsheet could require 8 to 24 total staff hours.

The calculator uses the 16-hour midpoint as a planning baseline. The FDA estimate is not the duration of a complete audit, investigation, or recall and does not measure TraceGuard AI savings.

FDA final regulatory impact analysis

Readiness evidence

FDA's 2026 tabletop exercises found that most participating firms responded within 24 hours and that proactive supply-chain coordination drove the strongest results.

The exercise included 15 voluntary companies and did not publish a representative software time-saving percentage. Technology does not replace data quality or coordination.

FDA traceability-readiness report

Recall containment

FDA's final regulatory analysis explains that faster, more precise traceability can reduce the breadth and duration of recalls and withdrawals.

This is an industry-level FDA conclusion, not a promise that TraceGuard AI will prevent or reduce any particular recall.

FDA final regulatory impact analysis

Establish your baseline first

Use the baseline workbook to record current search, reconciliation, follow-up, and evidence-packaging time. Use the disclosed planning assumptions before adoption, then repeat the same measurement after adoption so actual ROI can replace the modeled estimate.

Ready to evaluate the workflow?

Test the process with a timed mock recall.

See how TraceGuard connects records, traces the lot, surfaces gaps, and produces a reviewable closeout package.

View pricing