Batch Traceability Software: from Weigh Step to Mock Recall
Start from one batch and name every input lot, step, check and customer, then work back from a supplier lot. Capture the links as the work happens.
In Short
- Record lots at the step, not afterwards.
- Retention periods differ by sector.
- Test the trace on a real batch.
Inventory & Traceability: the Practical Operations Guide
From goods-in to dispatch: practical controls for locations, usable stock, movements, counting, picking and traceability. Use it with or without V5.
- Follow a lot both ways.
- Reconcile a trace before acting on it.
- Run a timed trace exercise.
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Inventory & Traceability: the Practical Operations Guide
From goods-in to dispatch: practical controls for locations, usable stock, movements, counting, picking and traceability. Use it with or without V5.
Batch traceability means you can start from one batch and name the input lots, equipment, people, checks and customers linked to it, then work the other way from a supplier lot. US rules ask for these records in different words for drugs, supplements, food and meat. Software helps only when the links are captured as the work happens. Sources checked 3 Oct 2026.
What a batch record has to show
For drugs, 21 CFR 211.188 requires a batch production and control record for each batch, including the dates, the identity of major equipment and lines used, the specific identification of each batch of component or in-process material used, weights and measures, in-process and laboratory results, and who performed and checked each significant step. Traceability software should capture those same facts at the step, not rebuild them from slips afterwards.
Retention Differs by Sector
Drug batch records are kept at least 1 year after the batch expiration date (21 CFR 211.180(a)). Supplement records are kept 1 year past shelf life, or 2 years beyond distribution of the last batch where no shelf life is used (21 CFR 111.605).
Minimum Record Retention by Rule
| Product | Period | Rule |
|---|---|---|
| Drugs | At least 1 year after batch expiry | 21 CFR 211.180(a) |
| Dietary supplements | 1 year past shelf life, or 2 years after last distribution | 21 CFR 111.605 |
| Meat and poultry | 2 years after 31 Dec of the transaction year | 9 CFR 320.3 |
| FSMA 204 foods | 2 years | 21 CFR 1.1455(d) |
- Drugs
- Period
- At least 1 year after batch expiry
- Rule
- 21 CFR 211.180(a)
- Dietary supplements
- Period
- 1 year past shelf life, or 2 years after last distribution
- Rule
- 21 CFR 111.605
- Meat and poultry
- Period
- 2 years after 31 Dec of the transaction year
- Rule
- 9 CFR 320.3
- FSMA 204 foods
- Period
- 2 years
- Rule
- 21 CFR 1.1455(d)
More on retention Differs by Sector
Meat and poultry records under 9 CFR 320 are kept 2 years after 31 December of the transaction year (320.3). FSMA 204 records for foods on the Food Traceability List are kept 2 years (21 CFR 1.1455(d)). Check the rule that applies to your product rather than one blanket period.
Where rework and re-blends break the chain
A reworked lot or a partial bag returned to stock is where ERP-only batch tracking often loses the link, because the movement is posted later or as an adjustment. Record rework as an input to the receiving batch, with quantity and the approval that allowed it, so the trace forward from the original lot includes the new batch.
Samples, Retains and Unexplained Differences
Quality samples, retains and scrap leave a batch too. If they are not recorded, the quantities do not reconcile and the gap needs explaining.
More on samples, Retains and Unexplained Differences
Record each sample against its parent lot with purpose and quantity, and let reviewers see yield differences against the limits set in the master record.
Test the trace before you need it
Pick a real finished batch and a real supplier lot. Trace both ways, including partial quantities, rework and several customers, and check the result against source records.
Worked Example: a Trace Exercise
- 09:00Supplier lot FL-2031 chosen; forward trace startedQuality
- 09:20Three batches found, one including rework from B-1180Quality
- 10:05Five customer shipments and stock on hand listedQuality
- 10:30Result checked against source records; one missing sample record notedQA manager
More on test the trace before you need it
Record who ran the exercise, how long it took and what was missing. Use your own result as the benchmark; no single time target applies to every business.
Questions
Can we run batch traceability on paper?
Yes. The rules require complete and accurate records, not software. Paper becomes hard to search when batches include rework, partial lots or many customers, and traces take longer to verify.
How long must batch records be kept?
It depends on the rule: drugs at least 1 year after batch expiry (211.180), supplements 1 year past shelf life or 2 years after last distribution (111.605), meat and poultry 2 years after the year end (9 CFR 320.3), FSMA 204 records 2 years (1.1455).
Does FSMA 204 apply to every food?
No. It applies to foods on FDA's Food Traceability List and to the entities that handle them, with exemptions. When it applies, records must be provided to FDA within 24 hours of a request or a reasonable time FDA agrees (1.1455(c)).
What does V5 do here?
V5 records lots through receiving, dispensing, production, rework and shipping, and can trace forwards and backwards from a lot or shipment. Your people decide on holds, recalls and notifications.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
Keep reading
- Lot Traceability Software: a Practical Genealogy Guide
Ingredient Traceability: Records, Lot Links and Bakery Examples
Chemical Traceability Software: Batch, Lot and SDS Records
Meat Traceability Software: 9 CFR 320 and Mock Recalls
Traceability Software Buyer's Guide: Capabilities to Test
FSMA 204 Food Traceability Readiness Guide