The GMP Native^™ Operating System

The GMP Native^™ Operating System for regulated 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

No credit card required • Cancel anytime • First batch record in 30 minutes

Built by a Manufacturer, for Manufacturers. Engineered for the way you actually run a batch.

EBR · BATCH BB-2241 · IN PROGRESS

1. Weigh-in: Turmeric Extract COMPLETE

2. Blend: 45 min at 800 RPM COMPLETE

3. QC sampling: 3 points IN PROGRESS

4. Encapsulation PENDING

5. QA e-signature release PENDING

Copilot suggestion

Step 3 assay: 98.4%, within spec. Suggest confirming and proceeding to Encapsulation.

Confirm & Continue Review individually

HMAC hash chain: active, every entry locked on save

COMPLIANCE INFRASTRUCTURE

Compliance that works
with you,
not something you work around.

🔥

“We failed an audit because we couldn’t find the paperwork.”

One cryptographically signed audit trail, inspection-ready on demand. No more all-nighters before an audit.

💸

“We didn’t catch the bad batch until we’d already sold it.”

YieldGuard flags anomalies in real time during the run, not after the recall.

📋

“We’re spending more time documenting than manufacturing.”

BatchBuddy automates the documentation layer so your team stays on the floor, not at a desk.

See how every control works →

One-click audit readiness

Manufacturer & above

Full batch history, lot traceability, production records, QC results, deviations, e-signatures, and an immutable audit trail. Complete and exportable in one action. No reconstruction, no consulting layer, no manual assembly. The record exists because the work was done correctly, not because someone assembled it afterward.

21 CFR Part 11 alignment

Role-based access, identity-verified approvals, and complete change history, enforced at the execution layer, not bolted on. FDA electronic record requirements are met by default, not by configuration.

Cryptographic audit trail

Every record is SHA-256 chained. Tamper-evident by design, so any change is permanently detectable. If an inspector asks who changed something and when, the answer is one click away.

E-signature enforcement

QA approvals, CAPAs, and batch releases require cryptographically bound signatures tied to authenticated users. Sign-offs cannot be skipped. They are enforced at the point of action, not requested after the fact.

Full lot traceability

Forward and backward, supplier to shipment, captured as production runs, not reconstructed after. FSMA 204 readiness by default. One search returns the complete chain.

BUILT-IN PROTECTIONS | READY FROM DAY ONE

These aren't settings you configure. They're safeguards woven into every workflow so your team is always on the right track.

Every release is signature-complete

BatchBuddy automatically collects all required QA signatures before a batch can be released. Your team ships with confidence, and every release is audit-ready.

FIFO is automatic, always

The system follows oldest-lot-first rotation by default, per GMP. Your operators pick materials; BatchBuddy makes sure they're always working from the right lot.

Yield is captured at close, every time

Runs close with yield documented, automatically prompted at completion. No chasing numbers after the fact, and no gaps in your batch record.

AI suggests; you decide

Every AI-proposed action is surfaced for your review before anything changes. Your team stays in control. The copilot is here to save time, not to act without you.

Your audit trail is always trustworthy

Every record is SHA-256 chained and append-only. Once committed, nothing can be altered or backdated. You get an audit trail you can stand behind in any inspection.

Permissions that actually hold

Access controls are enforced at the server level, not just the UI. Each team member can only take actions appropriate to their role. No workarounds, no accidental approvals.

MORE THAN ERP

From Static Records to Autonomous Actions

ERPs store data. BatchBuddy executes. Three capabilities no generic ERP can match.

Potency-Based Scaling

When your Vitamin C assay comes in at 94% instead of 100%, BatchBuddy automatically increases the required quantity so your finished product hits label claim every time.

Expected potency: 100%

Actual assay: 94.2%

Adjusted quantity: +6.2% quantity increase

No more manual math. No more label claim risk.

Write-Access AI Copilot

Most AI tools generate reports. BatchBuddy's copilot takes action, creating POs, starting runs, receiving inventory, and logging QC results. Every action needs your sign-off before it's committed.

14 actions across 5 areas of your operation:

Production Inventory Quality Purchasing Formulas & Orders

Enterprise plan. Every action audit-trailed.

24-Hour Implementation

SAP takes 6 to 18 months and a consulting team. BatchBuddy is built for operators, not IT. Import your formulas and produce your first compliant batch record on day one.

Import existing formulas (paste or CSV)

AI builds your ingredient library

First batch record in under 30 minutes

No consultants. No migration project. No downtime.

Works alongside your existing systems: SAP | NetSuite | Dynamics 365 | Odoo | QuickBooks

Start Enterprise Trial

14-day free trial • No credit card required • Full REST API for ERP sync

WHAT CHANGES ON DAY ONE

The operational gains are measurable.
The compliance posture is permanent.

3 days

becomes

3 hours

Audit prep time

One click generates a complete audit-ready batch record with e-signatures, deviation log, and tamper-evident hash. No binder assembly.

< 4 min

average time to complete

Full lot trace

Bidirectional recall trace

FSMA 204 gives you 24 hours. BatchBuddy surfaces every affected batch, supplier lot, and customer shipment in under 4 minutes.

92%

reduction in

Batch errors

Close-out & release errors

Yield must be recorded. Signatures must be collected. Deviations must be resolved. The system refuses to close a run that isn't complete.

2×

production volume at

Same headcount

Operational leverage

MRP plans the run. The copilot flags the shortages. QA reviews the record. Your team makes decisions. Not spreadsheets.

Based on customer-reported outcomes. Individual results vary by operation size and prior tooling.

COMPLETE LAB-TO-SHELF PLATFORM

Everything You Need. Nothing You Don't.

Four integrated pillars that cover the entire supplement manufacturing workflow from R&D to revenue.

Plan & Procure

Design formulas, plan material needs, and source ingredients all in one place.

Formulation management Ingredient library MRP & demand planning Supplier network Purchase orders CSV import & migration

MRP deep dive →

Make & Control

Run production with full traceability, compliance documentation, and quality controls built in.

Production scheduling Daily pick lists Batch execution Lot traceability COA & EBR 21 CFR Part 11 controls Audit readiness workspace Yield anomaly detection

EBR & compliance deep dive →

Sell & Get Paid

Manage customer orders, generate invoices, track payments, and ship from one dashboard.

Customer orders Invoicing & AR Payment tracking Client portal Shipping (UPS/FedEx/USPS)

Invoicing & AR deep dive →

Optimize & Integrate

Drive margins with cost intelligence from ingredients to finished packaging sync to QuickBooks, and automate with AI and API.

Cost intelligence Formula-to-packaging costing QuickBooks sync Team workspaces Enterprise API AI copilot

AI Copilot deep dive →

PROFIT PROTECTION ENGINE

Stop losing margin to invisible yield problems.

Most manufacturers only discover a bad ingredient lot weeks after it has touched multiple batches. BatchBuddy's Yield anomaly detection catches the deviation the moment a run closes — and automatically cross-references every suspect lot in your history.

Statistical z-score analysis

Compares each batch yield against the historical baseline for that formulation. Flags results more than 1.5 standard deviations below average — Warning or Critical severity, automatically.

Suspect lot cross-referencing

When a yield anomaly is detected, the system cross-references every ingredient lot used in that batch against your full production history. Shared lots across low-yield batches are flagged immediately.

21 CFR Part 11-aligned reports

Every anomaly generates a timestamped investigation report with z-score, severity, suspect lots, and full audit trail. If an FDA inspector asks — the answer is already documented.

Protect your margins from day one

Professional & Enterprise plans • No setup required

From spreadsheet chaos to audit confidence

You're up and running faster than you think.

Most teams complete their first real production run in BatchBuddy within their first week.

Connect your ingredient library

Import from CSV or paste directly. Set par levels, assign suppliers, and receive stock with full lot and CoA tracking. No manual re-entry, ever.

Your inventory is live in under 30 minutes.

Build formulas. Launch batch records.

Create your formula once, spin up production runs in clicks. Operator, timestamp, lots consumed, all captured automatically. No clipboards, no Excel.

Your first digital batch record, done today.

Full traceability, built in

Every lot traces from supplier → production → customer shipment, in both directions. FSMA 204 requires records within 24 hours of an FDA request, one search delivers the full chain, automatically.

Run a cryptographically signed recall drill →

Pull any document in seconds

FDA inspection, COA request, internal review: one click pulls a complete evidence package, COA PDF, frozen test results, and full audit trail in a single ZIP. No folder hunting.

Audit season goes from panic to routine.

Start Free Trial

14 days completely free • No credit card required • Cancel anytime

Built by people who've run supplement operations

We built the system we wished we had.

BatchBuddy was designed by contract manufacturers who lived through the spreadsheet chaos: batch record errors, last-minute inventory scrambles, audit anxiety. Every feature exists because we needed it first.

~20 min

Batch records that used to take half a day

Manufacturers consistently report completing batch records in under 20 minutes once formulations and inventory are set up compared to hours of manual spreadsheet work.

BatchBuddy · Based on reported user outcomes

Day 1

21 CFR Part 11-aligned controls built in from the moment you log in

Every action formula change, production run, inventory adjustment is automatically timestamped, user-attributed, and tamper-evident. No configuration required.

BatchBuddy · Built-in, not bolted on

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

No hidden costs • No long onboarding • Start using instantly

Not sure which plan fits? We'll walk you through it in 30 minutes.

See how we compare vs. the competition →

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
GMP-ready electronic batch records
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
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

Manufacturer

Quality & compliance

$749 /month

Save $1,498 with annual billing

YieldGuard™ quality suite included

Everything in Professional
COA module full lifecycle + e-signatures
Training records & Training Matrix
CAPA & OOS investigations
Recall simulation drill reports
HMAC-signed, audit-ready PDF reports FSMA 204-aligned lot traceability, two-step forward/back chain
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
Agentic AI Copilot (14 actions)
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

The GMP Native^™ Operating System for regulated manufacturers.

Compliance that works
with you,
not something you work around.