Industry
From contaminated lot to full impact map in 47 seconds.
Cortrova gives food and beverage manufacturers FDA-compliant lot traceability that maps a contaminated raw material to every batch, shipment, and customer in 47 seconds - versus the 5 to 7 days the industry still spends reconstructing it by hand. HACCP, FSMA 204, and 21 CFR Part 11 controls are wired into the workflow, not bolted on at audit time.
The challenge
- !A failed COA on receipt triggers days of spreadsheet archaeology before anyone knows which finished SKUs are affected
- !CCP monitoring lives on paper logs and clipboards that nobody reconciles until an auditor asks
- !Lot genealogy breaks at every system boundary - receiving, batching, QA hold, and shipping each keep their own records
- !Mock recalls take a week to run, so the real one is the first true test of whether the trace actually holds
- !21 CFR Part 11 evidence - audit trails, e-signatures, validation records - is reconstructed under pressure instead of captured as you work
How Cortrova answers
- ✓One continuous lot genealogy spans all five stages - receipt, batch, hold-and-release, distribution, and customer - so a forward or backward trace runs end to end without leaving the platform
- ✓Forward trace: a failed COA on a received raw material instantly maps every downstream batch, every shipment, and every customer that touched the affected lot
- ✓Backward trace: a consumer complaint resolves to the exact finished lot, the exact batch, and the exact supplier raw material, with full COA history attached
- ✓HACCP is enforced in the flow - hazard analysis, CCPs, measurable critical limits, continuous monitoring, and pre-defined corrective actions are recorded as production runs, not after
- ✓21 CFR Part 11 is built in: tamper-evident time-stamped audit trails, role-based access, permission-checked e-signatures with printed name, date, time, and meaning, and two-factor on first signing
- ✓Mock Recall runs the full impact map on demand - one source lot fanning out across SKUs, batches, distribution centers, and retail channels - in seconds, with FDA recall classification and customer notifications drafted automatically
Five stages, one trace
The lot never leaves the chain.
Every food and beverage lot moves through the same five stages, and Cortrova keeps the genealogy intact across all of them so a trace in either direction is one query, not a forensic project.
Receipt
Raw material COA is logged and a Lot ID is assigned the moment it arrives, anchoring everything downstream to a verified source.
Batch
Production CCPs are monitored against critical limits and every input lot is traced into the batch, so genealogy is built as you make product.
Hold & Release
QA testing gates the lot; micro and chem COAs are generated and the lot cannot ship until results clear the defined limits.
Distribution
Cold-chain temperature is logged and DC routing is recorded, so the trace follows the product through the supply chain, not just the plant.
Customer
Retail and QSR delivery is confirmed and the lot is closed, completing a chain that reaches from supplier raw material to the consumer.
Two frameworks, one platform
FDA and HACCP, enforced where the work happens.
Compliance is not a separate binder. The eight 21 CFR Part 11 control points and the seven HACCP principles are built into the same workflows that run production.
21 CFR Part 11
System validation, inspection-ready copies, retention and protection, role-based access, tamper-evident time-stamped audit trails, authority checks, signature manifestations (name, date, time, meaning), and two-factor on first signing.
HACCP
Hazard analysis across biological, chemical, and physical risks; CCP identification; measurable critical limits per CCP; continuous monitoring; pre-defined corrective actions per deviation; verification and audit procedures; and Codex-aligned recordkeeping.
FSMA 204
One-up one-back traceability is maintained automatically through the lot genealogy, so Key Data Elements and Critical Tracking Events are already in place when the rule applies.
Mock Recall
Run the recall before you need it.
A mock recall in Cortrova is a single action, not a week-long drill. From one contaminated source lot the platform builds the full impact map and stages the response.
One source lot fans out to 3 SKUs, 10 batches, 4 distribution centers, and 5 retail channels in the worked example
The full map is traced in 47 seconds, with FDA recall classification ready to apply
Customer notifications are drafted automatically so the team reviews and sends rather than starts from scratch
Every drill leaves a 21 CFR Part 11 record, so recall readiness is provable to an auditor
How it works
Adopting food & beverage.
Anchor every lot at receipt
Raw material COAs are logged and Lot IDs assigned on arrival, so genealogy starts at the supplier and nothing enters production untraced.
Monitor CCPs as you make product
Critical control points are watched against measurable limits during the batch, with corrective actions pre-defined for any deviation.
Gate release with QA
Micro and chem testing holds the lot until COAs clear; only released lots can ship, and the hold is part of the permanent record.
Trace on demand, recall in seconds
Forward or backward, the genealogy resolves the impact in seconds and stages recall classification and customer notifications.
Compliance frameworks
Built in, not bolted on.
FAQ
Questions, answered.
How fast can Cortrova actually trace a contaminated lot?
A mean of 47 seconds, versus the industry average of five to seven days. Because the lot genealogy is continuous across receipt, batch, hold-and-release, distribution, and customer, a forward or backward trace is a single query rather than a manual reconstruction across disconnected systems. In the worked example one contaminated source lot maps to 3 SKUs, 10 batches, 4 distribution centers, and 5 retail channels in that time.
How does Cortrova support FDA 21 CFR Part 11?
All eight control points are built into the workflow: system validation for accuracy and reliability, inspection-ready copies, defined retention and protection, role-based access limits, tamper-evident time-stamped audit trails, permission-based authority checks, signature manifestations that record printed name, date, time, and meaning, and two-factor authentication on first signing. The evidence is captured as you work, not assembled at audit time.
Is HACCP enforced or just documented?
Enforced. Hazard analysis covers biological, chemical, and physical risks; critical control points carry measurable critical limits; monitoring is continuous or on a defined schedule; corrective actions are pre-defined per CCP deviation; and verification and recordkeeping follow Codex Alimentarius and FDA guidance. The seven principles are wired into production, so a deviation drives an action and a record automatically.
Does Cortrova handle FSMA 204 traceability?
Yes. One-up one-back traceability is maintained automatically through the same lot genealogy that powers recall, so Key Data Elements and Critical Tracking Events are already in place. You can produce the records FSMA 204 requires without running a parallel system.
Can a mock recall be run on demand?
Yes. A mock recall is a single action: from one source lot Cortrova builds the full impact map across SKUs, batches, distribution centers, and retail channels, applies FDA recall classification, and drafts customer notifications. Every drill leaves a 21 CFR Part 11 record, so recall readiness is provable rather than assumed.
In the field
What food & beverage teams run.
Cut mean lot trace time from 5-7 days to 47 seconds
Map a failed receiving COA to every affected finished SKU instantly
Resolve a consumer complaint to the exact lot, batch, and supplier with full COA history
Pass SQF and FDA audits with e-records and audit trails captured as you work
Prove recall readiness with on-demand mock recalls that leave a compliant record
Get started
Built for food & beverage.
We'll tailor a demo to your environment and constraints.