The GMP Native™ Operating System

The GMP Native™ Operating System for regulated CPG manufacturers.

Not a module. Not a checklist.
The way the whole thing works.

Enterprise-grade compliance at SMB pricing. Live in days, not 18 months.

Explore the compliance controls →
eMR Batch Records
QMS Quality Control
MES Production Guide
PLM / ERP Formula & Inventory
YieldGuard Profit Protection
Gate 3 of 7 · Line Clearance
EBR · BB-2241 · Line Clearance REQUIRED BEFORE START
Pre-production checks 21 CFR Part 111
Previous batch materials & labels removed
Equipment cleaned — Log #CL-0421 attached
Lot #A-7823 verified in-spec for this formula ←
Operator qualified: Vitamin C Blend SOP
Copilot
SUGGESTED · PENDING CONFIRMATION
Lot #A-7823 potency 96.2% — recommends weigh-in target 10.39 kg to maintain label claim. Operator must confirm before it applies.
Confirm adjustment requires operator e-sig
Start Production Run
⚠ 2 checks remaining — button unlocks when all are attested
HMAC-SHA256 hash chain: active, every entry locked on save
BatchBuddy manufacturing assistant

Who this is for

Supplement & nutraceutical brands
21 CFR Part 111 compliance & COA management
Contract manufacturers & co-packers
Multi-brand batch records & audit trails
Cosmetics & personal care formulators
ISO 22716 GMP & MoCRA documentation
Food & beverage producers
FSMA, SQF & BRC lot traceability

You already have a batch record system. It’s a spreadsheet, a notebook, and your memory. It works, right up until the day someone asks you to prove it.

Compliance is built into production. Every batch is audit-ready by default.

3 hrs
Audit prep time
Was 3 days
< 4 min
Full lot recall trace
FSMA 204: 24 hr window
92%
Reduction in batch errors
Close-out & release
< 2 hrs
Batch close-out time
Was half a shift

Based on our Customer Zero results , your numbers will vary.

01 Formulate ─ 02 Source ─ 03 Plan ─ 04 Execute ─ 05 Certify ─ 06 Fulfill ─ 07 Optimize
STAGE 01

Formulate with
precision and cost clarity.

Build every formula once. Every ingredient, potency, supplier, and cost lives in one place: structured, versioned, and ready to go into production on day one.

  • Unlimited formulations with versioning. Roll back or fork a variant without losing history
  • Potency-based auto-scaling: when your COA assay comes in low, required quantity adjusts automatically
  • Live cost-per-unit calculated as you build, from raw material to finished packaging
  • Label claim verification: the system confirms ingredient quantities match your label before a run starts
Formulation deep dive
Formula Builder · Immune Defense Stack v3.2
Immune Defense Stack v3.2
✓ Label Claim MATCHED
Ingredient Qty Unit Potency COA
Vitamin C (Ester-C) 500 mg 98.4% ✓
Zinc Glycinate 25 mg 99.1% ✓
Elderberry 4:1 Extract 200 mg 96.2% ↑ ✓
Quercetin 50 mg 97.8% ✓
Cost / Unit
$0.42
Margin
68%
Start Production Run →
STAGE 02

Source ingredients.
Receive lots. Lock COAs.

Every ingredient that walks through your door gets a lot number, a COA, and a traceable chain. Before it ever touches a batch.

  • Purchase orders generated from MRP shortages, sent to your supplier network in one click
  • COA inbox: suppliers upload certificates directly, or your team imports via OCR. Potency values auto-populate the ingredient lot.
  • Supplier e-signatures: invite your supplier to sign their COA directly inside BatchBuddy, logged to the audit trail
  • FIFO enforced automatically: oldest lot gets picked first, per GMP, no operator decision required
Procurement & inventory deep dive
Purchase Orders · Sourcing Hub
PO # Supplier Status ETA
PO-1847 Sacred Legacy ✓ RECEIVED Aug 1
PO-1848 Love Water ● IN TRANSIT Aug 5
PO-1849 Koichi ○ PENDING Aug 8
COA Inbox 2 Pending Review
Zinc Glycinate · Lot ZG-4491 · Love Water Review →
Elderberry Ext. · Lot EB-2847 · Love Water Review →
STAGE 03

Plan production.
MRP catches shortages first.

Material Requirements Planning calculates exactly what you need for every order on your books. Shortages surface before you start the run, not midway through it.

  • Production scheduling with per-run material availability checks (green means go, yellow means order first)
  • Shortage alerts with one-click PO creation to resolve. From gap to order in under 60 seconds
  • Daily pick lists generated automatically: exactly which lots to pull, in FIFO order, before the shift starts
  • AI copilot flags demand spikes, staggers runs, and recommends PO timing to protect your lead times
MRP & demand planning deep dive
Production Schedule · Week of Aug 4
Run Formula Units Materials
RUN-091 Immune Stack 1,200 ● READY
RUN-092 Sleep Complex 800 △ SHORT
RUN-093 Joint Support Elite 600 ● READY
1 shortage · Melatonin 10mg · RUN-092
Need 48 g · Have 12 g · Shortfall 36 g Create PO →
Pick lists generated · 847 materials staged View Pick List →
STAGE 04

Run the batch.
The record writes itself.

Electronic Batch Records guide your operators step-by-step. Every weigh-in, every blend time, every QC reading is captured with a timestamp, lot number, and the operator who did it, locked to the HMAC chain on save.

  • Step-by-step EBR: custom process steps, mandatory fields, and approval checkpoints enforced at runtime
  • HMAC-SHA256 hash chain: every entry is cryptographically locked on save; tampering is permanently detectable
  • 21 CFR Part 11 e-signatures: re-authenticated, role-enforced, with separate supervisor approval required (Enterprise)
  • Yield anomaly detection: statistical z-score analysis flags low-yield runs the moment the record closes
EBR & compliance deep dive
EBR · BB-2255 · Joint Support Elite · IN PROGRESS
Operator: M. Rodriguez Shift: Aug 3, 08:00 Batch: 600 units
✓ 1. Pre-weigh verification & line clearance COMPLETE
✓ 2. Ingredient weigh-in: 6 components COMPLETE
● 3. Blend 45 min @ 800 RPM IN PROGRESS
4. QC sampling (3-point) PENDING
5. Encapsulation & yield recording PENDING
6. QA supervisor e-signature release PENDING
HMAC chain: ACTIVE · Every entry locked on save Step 3 of 6
STAGE 05

Quality controls that
can be proven, not just claimed.

CAPAs, OOS investigations, and the audit trail all live in one place. When an inspector asks, the answer is one click away, not a file-cabinet hunt.

  • CAPA & OOS investigations: open, track, and close quality events with full audit trail, e-signatures, and resolution documentation
  • HMAC-SHA256 hash chain: cryptographically tamper-evident audit trail; any alteration is permanently detectable
  • Auditor portal: give your external auditor a read-only view of the audit trail and batch records; no data export required
  • Recall drill simulation: run a cryptographically signed recall report in under 4 minutes; FSMA 204 ready by default
Compliance controls deep dive Run a recall drill
Quality & Compliance Hub
Open Quality Events
CAPA-014 Low yield · BB-2231 · Joint Support Elite HIGH 1d
OOS-007 Zinc lot AB-4419 · resolved CLOSED ✓
Audit Trail Integrity
Chain verification: INTACT
4,847
Records hashed
312
E-signatures
14:32
Last verified
Run Recall Drill → Export Audit Package
STAGE 06

Ship product.
Give every brand full visibility.

From invoicing to carrier labels, your fulfillment workflow lives alongside your batch records. Your brand clients see their order status in real time. No email threads, no status calls.

  • Fulfillment pipeline: each order shows exactly what stage it’s in, from formula through EBR completion to ready-to-ship
  • Multi-carrier shipping via Shippo: UPS, FedEx, USPS. Rate shop and print labels without leaving the order screen
  • Invoicing & AR: generate invoices, track payment status, and sync to QuickBooks in one step
  • Client portal: branded login for your brand clients; they see order status and tracking without seeing your formulas or pricing
Fulfillment & AR deep dive Client Portal →
Customer Orders · Fulfillment Tracker
Order Customer Stage Action
#4821 Whimsy Cookie Co ✓ EBR Complete Ship →
#4822 Ethereal ● Shipped · FedEx Track
#4823 Ivy Balm ○ Formula Stage View
Client portal: 3 brands active · Whimsy Cookie Co last viewed 2h ago Manage Portal →
STAGE 07

Intelligence that
protects your margins.

Most manufacturers discover a bad ingredient lot weeks after it has touched multiple batches. YieldGuard catches the deviation the moment a run closes, telling you exactly which lots to quarantine.

  • Cost intelligence: formula-level profitability updated in real time as ingredient costs change; margin tracked from raw to shelf
  • Statistical yield anomaly detection: z-score analysis flags batches more than 1.5σ below baseline, automatically
  • Suspect lot cross-referencing: when yield drops, every batch sharing that ingredient lot is flagged across your full production history
  • AI compliance assistant: 14 human-confirmed workflows that cut documentation time across purchasing, production, quality, and orders (Enterprise)
Yield intelligence deep dive AI Copilot →
Cost Intelligence · YieldGuard™
Formula Profitability
Formula Margin vs. Target
Immune Defense Stack v3.2 68.2% ▲ +4.1%
Sleep Complex 61.8% ▼ −2.3% ⚠
Joint Support Elite 72.1% ▲ +6.8%
YieldGuard™ Anomaly Detected z = −2.4σ
Zinc Glycinate · Lot AB-4419 · 3 affected batches. Shared lot flagged across production history.
Open CAPA → Quarantine Lot
THE ARCHITECTURE DIFFERENCE

Some platforms discourage compliance mistakes.
BatchBuddy prevents them.

There's a meaningful gap between software that logs what happened and software that makes the wrong thing detectable and unapprovable.

The inventory-first approach
  • — Login identifies you: e-signatures use your active session. No re-authentication at the point of action.
  • — Configurable approval chains: workflows can be adjusted, skipped, or self-approved by the same person who made the change.
  • — Activity log: records what happened. Doesn't cryptographically prove it hasn't been altered since.
  • — Traceability report: tells you which lots were affected. Doesn't generate a signed recall document you can hand an investigator.
  • — Compliance as a layer: QMS features were added after the inventory core. The system wasn't designed around a regulated workflow from the start.
The GMP Native™ way
  • Re-authenticated e-signatures (Enterprise): 21 CFR Part 11 requires it. Password re-entry is enforced at every regulated action, not assumed from login.
  • Two-person control enforced in code (Enterprise): supervisor approval is a hard gate at the route level. The operator cannot approve their own batch record.
  • HMAC-SHA256 hash chain: every entry is cryptographically locked on save. Any alteration is permanently and mathematically detectable.
  • Signed recall drill report: cryptographically signed PDF in under 4 minutes. Hand it to an FDA investigator on the spot. FSMA 204 ready.
  • Compliance is the foundation: GMP controls were written into the data model before the first feature. There's no layer to bolt on because it was never separate.
HOW WE COMPARE

Built for supplement & food manufacturers.
Not bolted on for them.

Inventory platforms add compliance as a layer. Batch Buddy was purpose-built for 21 CFR Part 111, FSMA, and MoCRA from the ground up.

Capability
Other platforms
Batch Buddy
GMP / 21 CFR Part 111 controls Active day one, no configuration
✗ Not available, or sold as optional add-on modules configured after purchase
Active from first login. Every route, every action is GMP-gated. No setup, no toggles.
21 CFR Part 11 e-signatures Enterprise Re-authentication at every regulated action
✗ Login-level signer ID: your active session signs for you. No password re-entry at the point of action.
Password re-entry enforced at every sign. Supervisor approval is a hard gate. Operators cannot approve their own batch records. Enterprise tier.
Tamper-evident audit trail HMAC-SHA256 hash chain, append-only
✗
Activity log, not a hash chain. Each entry is a standalone row in a database. An admin, a vendor patch, or a bug can alter or delete a record and the log has no way to detect it. "Tamper-evident" here means the UI shows who clicked what. The underlying data carries no cryptographic proof that it hasn't changed since it was written.
HMAC-SHA256 hash-chained: every record encodes a keyed cryptographic seal of the one before it. Edit, reorder, or delete any entry and the chain breaks permanently. There is no admin override that can restore it silently. This is what cryptographic tamper-evidence actually means under 21 CFR Part 11.
FSMA 204 recall readiness Signed drill report in < 4 minutes
✗ Traceability lookup: can tell you which lots were affected, but produces no signed recall document.
One-click signed PDF recall report. Forward and back lot chain, cryptographically signed. Hand it to an FDA investigator on the spot.
CAPA, OOS & yield anomaly detection Full quality event management
✗ Not available or partial. Quality events handled in a separate system or spreadsheet.
Built into the batch record system. Open, track, and close CAPAs with e-signatures and resolution docs. No separate QMS.
AI compliance assistant 14 human-confirmed workflows
✗ Not available. Requires manual workflows, external automation tools, or custom scripting.
14 actions across purchasing, production, and quality: every one requires explicit human sign-off before it writes. Enterprise tier.
Transparent self-serve pricing No sales call required to start
✗ From $299–600+/mo. Implementation fees common. Sales call often required before pricing is shared.
From $149/mo, published and self-serve. Start a free trial today.
See the full feature-by-feature breakdown →

Compared against Katana, Wherefour, and 7 more competitors →

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BatchBuddy is live on Zapier. Trigger automations when orders arrive, batches complete, or stock runs low. No code required.

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TRANSPARENT PRICING

Professional Plans That Scale With You

Start with what you need today. Upgrade seamlessly as you grow. All plans include a 14-day free trial.

14-Day Free Trial, cancel anytime, no long-term commitment

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Monthly
Annual Save 20%

Formulator

Individual workspace

$149 /month
Save $298 with annual billing
21 CFR Part 11-aligned audit trail included
  • Up to 100 formulations
  • Advanced formulation workspace
  • Full ingredient library
  • Production run tracking with GMP controls
  • Tamper-evident audit trail
  • FIFO inventory management
  • Customer orders & invoicing
  • Basic shipping integration
  • Email support
Start Free Trial

Professional

Teams + Integrations

$349 /month
Save $698 with annual billing
21 CFR Part 11-aligned audit trail included
  • Everything in Formulator
  • Unlimited formulations
  • MRP & demand planning
  • Full lot traceability & recall readiness
  • Recall simulation drill reports
  • HMAC-signed, audit-ready PDF reports FSMA 204-aligned lot traceability, two-step forward/back chain
  • Team collaboration (up to 5 members)
  • QuickBooks & Shopify integration
  • Multi-carrier shipping (Shippo)
  • Client portal ($49/mo add-on)
  • Supplier network & cost intelligence
  • Track pricing from formula to finished packaging
  • Priority email support
Start Free Trial
MOST POPULAR

Manufacturer

Quality & compliance

$749 /month
Save $1,498 with annual billing
YieldGuard™ quality suite included
  • Everything in Professional
  • Electronic Batch Records (EBR): step-by-step process control
  • COA module full lifecycle + e-signatures
  • Training records & Training Matrix
  • CAPA & OOS investigations
  • Advanced analytics dashboard
  • Yield anomaly detection
  • Team collaboration (up to 15 members)
  • Operator qualification history
  • Client portal included
  • Scheduled support calls
Start Free Trial

Enterprise

Unlimited + API

$1,499 /month
Save $3,598 with annual billing
  • Everything in Manufacturer
  • AI Compliance Assistant (14 workflows)
  • Receives inventory, creates batches, logs adjustments confirmation required before every write
  • Unlimited team members & departments
  • Full REST API for ERP integration
  • Advanced COA automation + bulk processing
  • API-driven COA generation, bulk OCR import, advanced workflows
  • Webhook subscriptions
  • Electronic Batch Records (EBR)
  • HMAC e-signatures (21 CFR Part 11 controls)
  • Dedicated account manager
  • Phone/video support & custom training
Start Free Trial
ADD-ON

Client Portal

Give your brand owners and clients their own secure login to track order status, production progress, and shipments in real time without a single phone call or email.

  • Branded login portal for your clients
  • Real-time order & production tracking
  • Shipment tracking with carrier links
  • Secure no formulas or pricing exposed
$49 /month

Included with Manufacturer and Enterprise. Add-on for Professional.

Start Free Trial

All plans include: 14-day free trial • Cancel anytime • No setup fees • No long-term contracts

You just make product. BatchBuddy makes sure every batch is already audit-ready.

Your next FDA audit is closer than you think

Stop running a GMP operation
from a spreadsheet.

Every day you wait is another batch record in a folder, another lot number in a tab, another audit you're not ready for. BatchBuddy fixes this, permanently.

Start Your Free Trial Hidden Cost Calculator
21 CFR Part 11-aligned controls from day one First batch record in under 30 minutes Cancel anytime, no lock-in

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