FDA 21 CFR Part 11-aligned electronic batch records with e-signatures, step-by-step process control, lot traceability, and a tamper-evident audit trail. Included in the Manufacturer plan ($749/month).
14 days completely free • No credit card required • Cancel anytime
When you run a production batch in BatchBuddy, the EBR workflow structures and captures a complete electronic batch record - everything an FDA inspector or quality auditor would look for, recorded step by step as your team works through the run.
You shouldn't need a six-figure budget to have 21 CFR Part 11-aligned batch records.
| Feature | BatchBuddy | MasterControl / TrackWise | Paper / Spreadsheets |
|---|---|---|---|
| Electronic Batch Records (EBR) | ✓ Included | ✓ Included | ✗ |
| 21 CFR Part 11-Aligned | ✓ | ✓ | ✗ |
| 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 | $749/month (EBR) | $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 21 CFR Part 11-aligned 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 support FDA FSMA and HACCP recordkeeping.
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 21 CFR Part 11-aligned 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. BatchBuddy's electronic batch records include tamper-evident audit trails, HMAC v3 cryptographic e-signatures with operator identity verification, role-based access controls, and permanent record storage, all mapping to FDA 21 CFR Part 11 requirements for electronic records in regulated manufacturing environments. Like all software vendors in this category, Part 11 alignment is self-declared per standard industry practice; FDA does not certify software.
BatchBuddy'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.
BatchBuddy 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. BatchBuddy 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.
BatchBuddy is purpose-built for manufacturing operations, formulation, batch records, inventory, production, cost management, CAPA, and GMP training records. It is not a general-purpose QMS with dedicated document control workflows or formal change control management. On the Manufacturer plan and above, CAPA lifecycle management and Training Records (including the Training Matrix and expiration tracking) are fully included. For most small and mid-size supplement, food, and cosmetics manufacturers, BatchBuddy 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
Electronic Batch Records included in the Manufacturer plan ($749/month). FDA 21 CFR Part 11-aligned.