FDA 21 CFR Part 11 compliant electronic batch records — generated on every production run — with e-signatures, lot traceability, and a tamper-evident audit trail. Starting at $149/month.
14 days completely free • No credit card required • Cancel anytime
Every time you run a production batch in Batch Buddy, the system automatically builds a complete electronic batch record — capturing everything an FDA inspector or quality auditor would look for.
You shouldn't need a six-figure budget to have FDA-compliant batch records.
| Feature | Batch Buddy | MasterControl / TrackWise | Paper / Spreadsheets |
|---|---|---|---|
| Electronic Batch Records (EBR) | ✓ Included | ✓ Included | ✗ |
| 21 CFR Part 11 Compliant | ✓ | ✓ | ✗ |
| Lot Traceability | ✓ Built in | ✓ | ✗ Manual |
| Formulation Management | ✓ Built in | Add-on / extra cost | Spreadsheet only |
| FIFO Inventory Control | ✓ Built in | Separate ERP needed | ✗ |
| COA Management | ✓ Built in | Add-on | ✗ |
| Starting Price | $149/month | $50,000–$250,000/year | Free — but not compliant |
| Implementation Time | Same day | 3–12 months | N/A |
| Contract Required | No — cancel anytime | Annual contracts | — |
Built for growing manufacturers who need FDA-compliant documentation without enterprise complexity.
Vitamins, nutraceuticals, protein powders, and functional foods. Track every capsule batch from raw material lot to finished label — with FDA GMP documentation built in.
Packaged foods, beverages, sauces, and specialty items. FIFO expiry rotation, allergen tracking, and batch records that satisfy FDA FSMA and HACCP requirements.
Skincare, haircare, and personal care products. Batch record documentation, ingredient lot tracking, and COA management for FDA-regulated cosmetics facilities.
Manage batch records for multiple client brands with proper IP separation. Client-tagged formulations, team-based access controls, and audit trails for every customer production run.
Manage your own formulations while your CM handles production. Keep full batch record visibility and ensure your manufacturing partner is meeting your documentation standards.
Building your first FDA-compliant manufacturing operation? Start with proper batch records from day one — without paying for systems designed for Fortune 500 pharmaceutical companies.
Batch record software — also called electronic batch record (EBR) software — captures and permanently stores all the information about a manufacturing production run. This includes ingredients used, lot numbers, quantities, operator identities, yield, deviations, and quality checks. It replaces paper-based batch manufacturing records (BMRs) and helps manufacturers meet FDA GMP documentation requirements.
Yes. Batch Buddy's electronic batch records include tamper-evident audit trails, e-signatures with operator identity verification, role-based access controls, and permanent record storage — all meeting FDA 21 CFR Part 11 requirements for electronic records in regulated manufacturing environments.
Batch Buddy's traceability search lets you enter any raw material lot number or batch number and instantly see the complete supply chain: which inventory batches were received, which production runs used them, what finished goods were produced, and which shipments went out. This gives you full recall readiness in under 30 seconds.
Batch Buddy is built with FSMA 204 supply chain traceability principles in mind. The lot-level ingredient tracking, production linkage, and shipment records support the key data element (KDE) requirements for food manufacturers subject to FSMA 204 traceability rules.
You can start generating electronic batch records on the same day you sign up. Batch Buddy doesn't require a multi-month implementation project or dedicated IT staff. Most users have their first formulation loaded and a production run documented within an hour of registering.
Batch Buddy is purpose-built for manufacturing operations — formulation, batch records, inventory, production, and cost management. It is not a full quality management system (QMS) covering document control, CAPA, or training management. For most small and mid-size supplement, food, and cosmetics manufacturers, Batch Buddy covers the core compliance documentation they actually need.
Start your 14-day free trial today. No implementation fees, no long-term contract, no six-figure price tag.
14 days completely free • No credit card required • Cancel anytime
Batch record software starting at $149/month. FDA 21 CFR Part 11 compliant.