FOOD AND BEVERAGE
For plants working under 21 CFR Part 117 and customer or certification scheme audits.
THE LOAD
Preventive controls and the food safety plan
Supplier verification
Allergen control
Sanitation records
Traceability and recall readiness
Customer and retailer audits, often more demanding than the regulator
USE CASES
01
Supplier certificate of analysis checked against specification
02
Allergen changeover and sanitation record completeness
03
Preventive control monitoring records and corrective actions
04
Lot genealogy from raw material to shipment
05
Recall simulation and traceability exercise
06
Customer audit and certification scheme preparation
07
Certificate expiry and audit dates
Worked example (illustrative)
A supplier CoA for a flour lot shows a result within the supplier's limit but outside the plant's specification. The agent flags the lot and the finished-goods lots that used it.
REGULATIONS
21 CFR Part 117
FDA Food Traceability Rule
FDA Food Safety Modernization Act preventive controls for human food, 21 CFR Part 117; FDA Food Traceability Rule under FSMA section 204 (21 CFR Part 1, Subpart S), which applies to foods on the Food Traceability List. FDA will not enforce it before July 20, 2028.
Release, certify or disposition a batch
Close a deviation, investigation or CAPA
File anything with an authority
Write to your systems outside the transitions you approve
Send a message without a named person's approval
Contact a regulatory authority or a customer
Promote itself to a higher autonomy level
Make you compliant. Compliance decisions and accountability stay with you.
FAQ
Which regulations do the food and beverage agents work with?
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21 CFR Part 117, the FDA preventive controls rule for human food, and the FDA Food Traceability Rule under FSMA section 204 (21 CFR Part 1, Subpart S), which applies to foods on the Food Traceability List.
When will FDA enforce the Food Traceability Rule?
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FDA will not enforce it before July 20, 2028.
What happens when a supplier CoA is within the supplier's limit but outside our specification?
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The agent flags the lot and the finished-goods lots that used it.
Does an agent make the decision?
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No. The agents never release, certify or disposition a batch, never file anything with an authority, and never send a message without a named person's approval.
Send an export for one batch or lot and see the workspace run on your own data.
