21 CFR Part 11 Aligned FSMA 204 Ready PLM / ERP

The AI Operating System for Your Factory Floor.

The PLM / ERP built for supplement, food & cosmetics manufacturers.

The confidence of knowing your factory is audit-ready at any moment meets the magic of telling an AI to handle complex manufacturing workflows in plain English.

No credit card required • Cancel anytime • First batch record in 30 minutes
Copilot Active
We just received 500kg of Whey Protein Isolate, lot WPI-2026-003. Update inventory, check the CoA for potency, and scale tomorrow's Muscle Blend run to match.
3 actions queued:
Inventory updated 500 kg Whey Protein Isolate, lot WPI-2026-003
CoA potency checked 94.2% assay, scaling formula to compensate
Muscle Blend run scaled adjusted to 531 kg for 100% label claim at 94.2% potency
Every decision audit-trailed • 21 CFR Part 11-aligned controls
Batch Buddy AI manufacturing assistant
21 CFR Part 11-Aligned
|
FSMA 204 Ready
|
SHA-256 Immutable Audit Trails
|
ISO 22716 / SQF / BRC
|
Live in 24 Hours
BUILT FOR REGULATED MANUFACTURING

An AI Brain You Can Trust With Your FDA Audit

Every AI decision flows through the same compliance architecture that protects your manual processes because intelligence without accountability is just a liability.

Human-in-the-Loop

The AI proposes, you approve. Every critical action requires explicit human confirmation before execution no autonomous overrides on regulated processes.

SHA-256 Audit Chain

Every AI decision is cryptographically chained to a tamper-proof audit trail. If an FDA auditor asks "who changed this and why," the answer is one click away.

E-Signatures Built In

CAPA closures, batch releases, and COA approvals require identity-verified electronic signatures the same 21 CFR Part 11 controls your QA team expects.

Compliance Gates

The AI cannot bypass role-based access, skip required fields, or release a batch without proper approvals. Intelligence operates within the rules, not around them.

MORE THAN ERP

From Static Records to Autonomous Actions

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

Potency-Based Scaling

When your Vitamin C assay comes in at 94% instead of 100%, Batch Buddy 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. Batch Buddy'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 confirmed write actions:
Start production Complete batch Log run cost Receive inventory Adjust inventory Add ingredient Log deviation Quarantine/release Create CAPA Create PO Add customer Create order Import formula Update costs

Enterprise plan. Every action audit-trailed.

24-Hour Implementation

SAP takes 6–18 months and a consulting team. Batch Buddy 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

PROFIT PROTECTION ENGINE

Your Batches Talk.
We Make Sure You're Listening.

When a batch completes, Batch Buddy automatically checks for yield anomalies. If something's off, it tells you now, identifies the suspect ingredient lot, and shows you every other batch it touched.

Instant Anomaly Detection
Statistical analysis flags yield deviations the moment a batch completes. No manual review needed.
Suspect Lot Cross-Referencing
Traces ingredient lots from low-yield batches across your production history to find the common denominator.
Audit-Ready Investigation Reports
Every anomaly generates a timestamped report with full lot traceability, ready for 21 CFR Part 11 inspection.
Start Protecting Your Margins

Manufacturer plan and above • Runs automatically on completed batches

Yield Anomaly Detected CRITICAL
// Autonomous analysis triggered automatically
Batch: PRD-2026-0847 (Magnesium Complex 120ct)
Yield: 82.3% (avg: 96.8% across 14 runs)
Deviation: 2.7σ below mean
SUSPECT LOT IDENTIFIED:
Magnesium Citrate (Lot: MC-2026-1142)
Used in 3 batches all yielded below threshold:
PRD-2026-0839 → 84.1%
PRD-2026-0843 → 86.7%
PRD-2026-0847 → 82.3% (current)
RECOMMENDED: Quarantine lot MC-2026-1142.
Contact supplier for COA re-test.
Early
catch bad lots before they ship
Instant
vs. weeks with spreadsheets
21 CFR
audit-ready evidence
YIELDGUARD™ QUALITY MANAGEMENT

Train Your Team.
Prove It to Auditors.

GMP training records, SOP qualifications, and equipment certifications, all in one place. See who's qualified for what, and catch expiring certifications before they become audit findings.

  • Training Matrix Operator-by-topic status grid. Green, yellow, red, at a glance, no binder digging.
  • Expiration Tracking "Due soon" alerts fire 30 days before a certification expires. No last-minute scrambles before an audit.
  • Operator Validation ENTERPRISE Warns at production start when an operator's training is lapsed. Never blocks production, just documents the gap.
  • CAPA & OOS Investigations Full CAPA lifecycle: root cause analysis, severity tracking, and CSV audit export.
Manufacturer tier & above Operator validation: Enterprise only
Training Matrix Preview
Operator GMP Blending SOP Tablet Press
Sarah M. Current Current Current
James K. Current Due Soon
Maria L. Expired Current Current
Training Advisory: Maria L. GMP training expired on 2026-02-15. Renewal recommended before next production run.
RECALL SIMULATION

When FDA calls, you have hours, not days.
Prove you're ready before they ask.

Most manufacturers find out they weren't ready during an actual recall. Batch Buddy lets you find out during a drill with a cryptographically signed, tamper-evident report that holds up to regulatory scrutiny.

  • Live data. Instant trace. No import step, no re-entry. The trace runs on your actual inventory, batch records, and shipment data already in the system.
  • HMAC v3 cryptographic signing. Mathematically commits to the complete data state, signer identity, role, and signing timestamp. Tamper-evident. Permanently locked. An enterprise-tier control at this price point.
  • CAPA in the same system. Any gap found during the drill links directly to a corrective action in the same session, without a separate QMS integration.
Manufacturer tier & above Learn more
Recall Drill 4 Steps
1
Enter the suspect lot
Lot number + recall class. That's the only manual input required.
2
Automatic bidirectional trace
Forward: lot → production runs → finished goods → customer shipments. Backward: finished goods → all upstream suppliers. Simultaneously, on your live data.
3
Review the impact summary
Units at risk, shipped, on hand, customers affected calculated automatically from your live records.
4
Sign and lock the report
Response time documented automatically. HMAC v3 signed and permanently locked. Audit-ready for FDA, NSF/SQF/BRC, or brand owner review.
Response time documented HMAC v3 signed Permanently locked FSMA 204-aligned
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

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

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)

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 Barcode scanning

From Spreadsheets to Audit-Ready in One Day

Built for supplement, food, and cosmetics manufacturers who've outgrown Excel without the cost or complexity of an ERP.

What you're probably using now

Spreadsheets

Excel • Google Sheets • Manual records

  • No tamper-evident audit trail
  • No lot traceability
  • No electronic batch records
  • One FDA inspection away from a serious problem
VS
from $149/month · no credit card required

Batch Buddy

FDA-ready PLM-ERP built for supplement manufacturers

  • 21 CFR Part 11-aligned controls from day one
  • First batch record in under 30 minutes
  • No credit card required to start
Start Free Trial 14 Days
VS
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.

1
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.
2
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.
3
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.

4
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

⚡ ENTERPRISE AI COPILOT

An AI That Actually Does the Work

Most AI tools answer questions. BatchBuddy's copilot takes action analyze your production schedule, identify material shortages, create purchase orders, adjust for potency, and more. All from a simple chat.

MRP shortage analysis Create purchase orders Receive inventory Start production Complete batch + QC Log deviations Quarantine lots +5 more
Your confirmation required before every write. All actions audit-trailed with 21 CFR Part 11-aligned controls.
Try Enterprise Free for 14 Days →
No credit card required  ·  14 confirmed write actions
BatchBuddy AI Copilot
What do I need to buy for the next 30 days?
MRP Shortage Analysis
Based on 3 scheduled production runs, you have 2 shortages:
Turmeric Extract URGENT
Need 45 kg · On hand: 12 kg · Short 33 kg
Potency-adjusted: your formula targets 50% curcuminoids, last lot tested 45%
Magnesium Citrate
Need 80 kg · On hand: 55 kg · Short 25 kg
Create a PO for the turmeric extract from NutraChem
Create Purchase Order
Turmeric Extract · 33 kg · NutraChem
Last price: $42.00/kg · Est. total: $1,386.00
✓ PO created for 33 kg Turmeric Extract from NutraChem. Logged and audit-trailed.
Enterprise plan  ·  21 CFR Part 11-aligned audit controls
Client Portal Acme Supplements
Order #ORD-2026-0847
Omega-3 Fish Oil 1000mg · 10,000 units
In Production
Production Progress 72%
Batch
BT-2026-0412
Est. Ship
Mar 28, 2026
Ingredients sourced Mar 15
QC passed Mar 18
Encapsulation in progress
FOR CONTRACT MANUFACTURERS

Give Your Clients Their Own Portal

Stop fielding "where's my order?" calls. Each client gets their own secure login to track order status, production progress, and shipment tracking without seeing other clients' data or your margins.

Real-Time Order Visibility
Clients see production status, estimated ship dates, and tracking numbers the moment they're available.
Complete Data Isolation
Each client only sees their own orders. Your formulations, costs, and other clients' data stay completely private.
Hours Saved Every Week
Every status question a client answers themselves is time your team gets back for production.
Start Free Trial Add-on for Professional · Included with Enterprise
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.

Batch Buddy · Based on reported user outcomes
★★★★★

"We went from spending half a Friday building batch records to getting them done in 20 minutes. Our inventory discrepancies are gone no more waste, and we're producing on schedule for the first time."

— Nate Stickle, Founder Nova · Austin, TX
★★★★★

"In our first month we ran 200 inventory receipts through the AI Copilot. Every lot number, expiry date, and supplier cost captured and audit-trailed automatically zero manual entry errors. It's the first time our records have been 100% clean going into an audit."

— Sissy Lee, Founder Sacred Legacy
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.

Batch Buddy · Built-in, not bolted on

Built for Growing Manufacturers at Every Stage

Whether you're launching your first product or managing multiple production lines, Batch Buddy scales with your business.

Supplement Manufacturers

Dietary supplements, vitamins, nutraceuticals, and functional ingredients

  • Potency-based formula scaling (assay compensation)
  • Label claim verification against active ingredients
  • 21 CFR Part 11-aligned batch records & audit trails
  • COA management with spec matching
  • Ingredient lot traceability from raw material to finished good
Food & Beverage Producers

Specialty foods, beverages, functional foods, and contract packing

  • FSMA 204 traceability (one-up/one-back in 24 hours)
  • Allergen tracking across formulas and production lines
  • Yield anomaly detection to catch waste before it compounds
  • Recall simulation drill reports for SQF/BRC audits
  • Supplier COA validation and quarantine workflows
Cosmetics & Personal Care

Skincare, haircare, OTC topicals, and contract manufacturing

  • ISO 22716 GMP-ready batch documentation
  • Stability and shelf-life tracking per lot
  • Multi-client blind formulation access for contract labs
  • Packaging BOM management tied to production runs
  • E-signature workflows for batch release and QC approvals
All plans include: 21 CFR Part 11-aligned controls • FSMA 204 traceability • Complete audit trails • Real-time cost intelligence
Built for: Health & Supplements Beauty & Personal Care Food & Beverage Contract Manufacturing Nutraceuticals & Functional Foods Private Label Brands Startups & Scale-Ups
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.

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
MOST POPULAR

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

Enterprise-Grade Cryptographic Integrity. Manufacturer Plan Pricing.

Batch Buddy's HMAC v3 cryptographic signing, with published canonical string specs, version history, and independent verifiability, delivers the same tamper-evident audit trail architecture typically found in platforms priced at five to six figures annually. See the full specification on our Trust page.

MATERIAL REQUIREMENTS PLANNING

Never Run Out of Raw Materials Again

Batch Buddy's MRP engine looks at your production schedule and your current inventory, then tells you exactly what's short before the production floor finds out the hard way.

Demand Aggregation
Rolls up every scheduled production run to calculate total ingredient demand across your planning horizon.
Shortage Detection
Compares demand against on-hand stock and open POs. Flags shortages in red before they stall production.
Actionable Shortage Reports
Export shortages to CSV or view them inline. See exactly which suppliers carry each short ingredient with costs pre-loaded from your library.
Try MRP Free for 14 Days Professional & Enterprise plans
MRP Summary Next 30 Days 3 shortages
Vitamin C (Ascorbic Acid)
Need: 120 kg • On hand: 145 kg
Covered
Magnesium Glycinate
Need: 80 kg • On hand: 22 kg • Short 58 kg
Shortage
Fish Oil (EPA/DHA)
Need: 200 kg • On hand: 50 kg • PO pending: 100 kg • Short 50 kg
Shortage
Gelatin Capsule Shells
Need: 500k units • On hand: 800k units
Covered
Real MRP data from your production schedule • Updated in real time
Accounts Receivable This Month $42,800 outstanding
INV-2026-0089 • Acme Supplements
Omega-3 Complex • 10,000 units • $18,500
Paid
INV-2026-0090 • NutriVita Co.
Vitamin D3 5000 IU • 25,000 units • $24,300
Due in 12 days
INV-2026-0091 • GreenLife Labs
Magnesium Glycinate • 5,000 units • $8,750
Overdue 5 days
Invoiced
$51,550
Collected
$18,500
Overdue
$8,750
Order → Invoice → Payment • Full lifecycle in one platform
INVOICING & ACCOUNTS RECEIVABLE

Get Paid Faster. Stop Chasing Invoices.

Turn completed orders into professional invoices with one click. Track payments, flag overdue accounts, and see your cash position at a glance without switching to a separate accounting tool.

One-Click Invoice Generation
Create invoices directly from fulfilled orders. Line items, quantities, and pricing auto-populated.
Payment Tracking & Aging
See outstanding balances, aging buckets, and payment history per customer. Never lose track of who owes what.
QuickBooks Sync Professional+
Invoices and payments sync to QuickBooks automatically. No double-entry, no reconciliation headaches.
Start Free Trial Invoicing on all plans • QuickBooks sync on Professional+
COMPLIANCE & TRACEABILITY • 21 CFR PART 11-ALIGNED CONTROLS

Batch Records, COA, and Audit Trails Without the Enterprise Price Tag

Enterprise batch record systems like MasterControl and TrackWise cost $50,000–$250,000 per year. Batch Buddy delivers electronic batch records (EBR) built for real manufacturers, starting at $149/month.

Every production run automatically generates a complete electronic batch record: ingredients used with exact lot numbers, quantities, operator identity, yield calculations, deviations, and a tamper-evident audit trail with e-signatures. Designed for FDA inspection readiness if you ever face an audit or need to issue a recall, your records are ready instantly.

Electronic Batch Records
Generated on every production run
Lot Traceability
Raw material to finished good in seconds
E-Signatures & Audit Trail
21 CFR Part 11-aligned, tamper-evident
FIFO Inventory Control
Automatic expiry rotation per GMP
COA Management Manufacturer+
Full lifecycle COA with AI-powered supplier import, database-level immutability, and one-click audit packages
Recall Readiness
Full supply chain trace for FDA GMP
14 days completely free • No credit card required • Cancel anytime
Sample Batch Record
Auto-generated by Batch Buddy
COMPLETE
BATCH NUMBER
BT-2026-0042
FORMULA
Omega-3 Complex 1000mg
BATCH SIZE
50,000 capsules
YIELD
98.4%
INGREDIENTS USED
Fish Oil (EPA/DHA) Lot #FO-8821 50.0 kg
Vitamin E (d-alpha) Lot #VE-0034 2.5 kg
Gelatin Capsule Shell Lot #GC-1102 12.0 kg
OPERATOR E-SIGNATURE
J. Martinez 2026-03-04 09:17 UTC
AUDIT TRAIL
21 CFR Part 11 ✓
Every production run generates a record like this automatically. No manual data entry.
Audit Readiness Score
Live compliance dashboard
87%
Overall Readiness 87%
COMPLIANCE CHECKLIST
Training Records All operators current
CAPA Actions 12 closed, 0 overdue
Batch Records 100% complete with e-signatures
SOP Review 2 documents due for annual review
Audit Trail Hash-chain integrity verified
Updated in real-time as your team works. No manual checklists.
AUDIT READINESS WORKSPACE • INDUSTRY FIRST

Walk Into Every Audit Confident

Most manufacturers spend days sometimes weeks scrambling to prepare for FDA or ISO audits. Batch Buddy's Audit Readiness Workspace tells you exactly where you stand, right now, at a glance.

Unlike traditional ERP systems that just log data and leave you to figure out compliance yourself, the Audit Readiness Workspace proactively aggregates your training status, open CAPAs, batch record completeness, document review dates, and audit trail integrity into a single live score. You'll know what's ready and what needs attention before an auditor ever asks.

Live Readiness Score
Real-time compliance percentage across all areas
Gap Detection
Flags overdue training, open CAPAs, and missing records
Team Accountability
See which operators need updated training or qualifications
Always Current
Updates automatically as your team completes tasks
Recall Simulation Drills
Documented mock recall evidence with HMAC-attested signed reports
Recall Simulation Prove readiness before FDA asks
Run a full bidirectional trace on your live production data. Response time documented automatically. HMAC v3 signed report permanently locked. One export presentable to an FDA inspector or NSF/SQF/BRC auditor on demand.
FSMA 204-aligned 21 CFR Part 11 controls Manufacturer plan & above
See how recall simulation works →
Not available in competing PLM/ERP systems at this price point

Supplier Network

Invite your suppliers to join the Batch Buddy network and streamline your sourcing. When your supplier is on the platform, their ingredients and pricing flow directly into your formulations and purchase orders no more manual price lookups or back-and-forth emails.

Invite
Your Own Suppliers
Direct
Ingredient Integration
Built-in
RFQ Workflow
Network
Effect Growth
Marketplace Search Results
Organic Magnesium Glycinate
NutriSource Labs
$12.50/kg Min: 25kg
Vitamin D3 (5000 IU)
PureLab Supplies
$8.75/kg Min: 10kg

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. Batch Buddy fixes this, permanently.

21 CFR Part 11-aligned controls from day one First batch record in under 30 minutes Cancel anytime, no lock-in