BatchBuddy gives food manufacturers, from small-batch CPG brands to high-volume co-manufacturers, the documentation infrastructure to satisfy FDA FSMA preventive controls requirements, pass SQF and BRC audits, and trace any lot in minutes, not days.
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FSMA's preventive controls framework exists because reactive enforcement wasn't working. Auditors now expect your documentation to prove prevention, not just intent.
were rooted in documentation deficiencies, missing calibration records, incomplete corrective action logs, traceability gaps. Audits fail on paperwork, not product.
Every major GFSI scheme now requires a documented food fraud vulnerability assessment. Most food manufacturers still manage this on spreadsheets.
The FDA has moved past education. Preventive controls, supplier verification, and lot traceability are no longer new concepts, they are baseline requirements. The agency is now moving more quickly to formal enforcement actions when gaps persist. A warning letter is public. An import alert stops your product at the border.
At the same time, your retail buyers aren't waiting for the FDA. Walmart requires SQF. Whole Foods requires BRCGS or FSSC 22000. Costco conducts its own qualification audits. Without a GFSI certificate, you're not on the approved supplier list, regardless of how good your product is.
Food safety certification audits don't fail because of bad product. They fail because of missing records.
The requirements overlap significantly. The documentation infrastructure that satisfies FSMA is largely the same infrastructure that earns a strong SQF or BRC grade. BatchBuddy builds that infrastructure once, and it works for both.
| FSMA 21 CFR Part 117 Requires | SQF Ed. 9 / BRCGS Issue 9 Require | BatchBuddy Covers |
|---|---|---|
| Written food safety plan with hazard analysis | HACCP plan, supplier qualification | Batch records + CAPA + COA management |
| Preventive controls (process, allergen, sanitation, supply chain) | Lot traceability, internal audit records | FSMA 204 lot traceability chain |
| Monitoring, corrective actions, verification | CAPA logs, training documentation | CAPA + OOS workflows + training records |
| Recordkeeping | Food fraud vulnerability assessment, tamper-evident records | Cryptographic audit trail + e-signatures |
One system. Both audits.
Purpose-built for food manufacturers who need to satisfy regulatory and certification requirements simultaneously, without a dedicated compliance department.
Every production batch generates a complete, signed record, formulation, lot inputs, in-process checks, yield, QC disposition, and release signatures. FSMA 21 CFR Part 117 requires you to document preventive control monitoring at the time it's performed. BatchBuddy captures it in sequence, linked to the lot, ready for an FDA investigator or SQF auditor on demand.
FSMA Rule 204 requires high-risk food manufacturers to trace a lot within 24 hours. BatchBuddy traces every ingredient lot from supplier through production to finished goods and customer shipments, forward and backward simultaneously. One search. Complete chain. SQF and BRCGS auditors ask the same question. The answer is the same.
FSMA's supply chain program requires supplier verification for every ingredient that controls a hazard. BatchBuddy imports supplier COAs via OCR, no manual re-entry, and HMAC v2 cryptographically signs every certificate. Out-of-spec COAs trigger your OOS workflow automatically. Every supplier decision is documented and auditable.
BRCGS audits fail on corrective action gaps, actions that were taken but never documented end-to-end. BatchBuddy's CAPA module opens a structured investigation workflow the moment a deviation, OOS result, or process departure is logged. Root cause, corrective action, preventive measures, and effectiveness verification all live in one traceable record.
Food fraud cases surged 10% in 2024. Every major GFSI scheme, SQF, BRCGS, FSSC 22000, now requires a written food fraud vulnerability assessment. BatchBuddy's supplier and ingredient documentation infrastructure supports your FFVA records, linking ingredient sources, COAs, and supplier qualification directly to your food safety plan.
Every record in BatchBuddy is SHA-256 hash-chained and append-only. No user can alter, backdate, or delete a committed entry. When an FDA investigator or SQF auditor asks for the audit trail on a deviation or corrective action, the answer is immediate and unimpeachable. Data integrity is a recurring FDA enforcement focus.
BatchBuddy's bidirectional recall simulation runs on your live production data, forward to every customer shipment, backward to every supplier lot. The signed, locked report is ready for an FDA investigator, SQF auditor, or retail partner on demand. FSMA gives the FDA mandatory recall authority. Knowing your exposure before a recall is declared changes the outcome.
FSMA requires that personnel engaged in preventive control activities be qualified, trained and documented. SQF and BRCGS both expect training records current, role-specific, and searchable during an audit. BatchBuddy's Training Records module tracks completion, sign-offs, SOP version alignment, and retraining triggers.
SQF Edition 9 and BRCGS Issue 9 auditors follow a structured checklist. They will ask for your HACCP plan. They will request your CAPA log and corrective action history. They will trace a lot, forward and backward, and time how long it takes. They will ask to see your most recent supplier COA review and your training records for the staff who ran last Tuesday's production.
BatchBuddy is designed so audit readiness is the byproduct of normal operations. Every record the auditor asks for was captured at the time of the event, signed, and stored in a searchable, tamper-evident system. You don't scramble the week before. You open BatchBuddy.
FSMA Rule 204 established traceability requirements for high-risk foods, requiring food businesses to maintain Key Data Elements (KDEs) and Critical Tracking Events (CTEs), and to produce a full supply chain trace within 24 hours of an FDA request.
BatchBuddy's lot traceability tracks every CTE, receiving, transformation, creation, and shipping, and links every KDE to the batch record it belongs to. A complete FSMA 204-compliant trace runs in minutes, not hours. The signed output is ready to hand to an FDA investigator at any point during the traceability window.
A practical, requirement-by-requirement checklist covering FSMA 21 CFR Part 117 preventive controls, with SQF/BRC alignment notes and a 90-day audit readiness plan. Used by quality managers to self-assess before an unannounced inspection or certification audit.
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For Food Manufacturers & Co-Manufacturers
BatchBuddy gives food manufacturers the documentation infrastructure that satisfies FDA FSMA preventive controls requirements and earns strong SQF and BRC audit grades, automatically, at every step, from the first batch to the last shipment.
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