BatchBuddy Newsroom

FOR IMMEDIATE RELEASE
Media Contact: press@batchbuddy.ai

AUSTIN, TX — A growing number of supplement, cosmetics, and food manufacturers are discovering that the electronic records their compliance software produces may not meet the standard FDA investigators actually apply during inspections. During a 21 CFR Part 11 review, FDA investigators look for evidence that electronic records cannot be altered without detection — a requirement most mainstream compliance platforms fail to satisfy.

The problem is structural. Most electronic batch record and quality management systems store records in mutable databases with no cryptographic verification layer. A record can be changed, backdated, or deleted by a sufficiently privileged user with no permanent forensic trace. From a regulatory standpoint, these records are legally vulnerable.

BatchBuddy, a GMP-aligned manufacturing operations platform built for supplement, food, and cosmetics manufacturers, has taken a different approach. Every record written to the platform is protected by a SHA-256 hash chain and a HMAC v3 cryptographic e-signature system, making any tampering detectable by the platform's own audit infrastructure. The system meets the data integrity standard FDA investigators apply, not just the minimum technical checklist.

"We built BatchBuddy because we ran a GMP facility and couldn't find software that actually held up the way the FDA expected," said Kelly Hackett, CEO and co-founder. "Data integrity isn't a checkbox. It's the reason your records mean something during an inspection."

BatchBuddy's cryptographic audit trail is available on all plans starting at $149/month, with no implementation fee. The platform is designed for small and mid-size manufacturers who need enterprise-grade compliance infrastructure without the six-figure implementation cost that has historically reserved it for large operations.

BatchBuddy is a GMP-aligned manufacturing operations platform built for supplement, food, and cosmetics manufacturers. Learn more at batchbuddy.ai.

FOR IMMEDIATE RELEASE
Media Contact: press@batchbuddy.ai

AUSTIN, TX — BatchBuddy today announced general availability of its AI Copilot, a write-access AI assistant embedded directly inside its manufacturing operations platform. The Copilot is the first in its category to combine plain-language manufacturing commands with a compliance-native architecture that logs every AI action to the same FDA 21 CFR Part 11 audit trail used by human operators, with explicit human confirmation required before any action is committed.

The Copilot supports 14 confirmed write actions, including receiving inventory, creating production runs, adjusting batch quantities, recording quality checks, and initiating CAPA investigations. Unlike AI assistants that answer questions or surface information, BatchBuddy's Copilot executes operations inside the manufacturing system — the equivalent of a skilled operator who can be directed in plain English.

"Every AI action goes through the same audit infrastructure as a human action," said Cholee Hackett, CTO and co-founder. "That's not a nice-to-have in a regulated environment. It's the only way we were willing to ship it."

The Copilot is tier-gated by design. Trial-tier users have access to informational queries. Write actions are available on Professional and Enterprise plans. Enterprise-only write actions — including production run initiation — are restricted to Enterprise subscribers, with the architecture enforced at the API level, not the UI level.

The AI Copilot is available immediately to all BatchBuddy subscribers on eligible plans. Pricing begins at $149/month with no implementation fee. Learn more at batchbuddy.ai.

BatchBuddy is a GMP-aligned manufacturing operations platform built for supplement, food, and cosmetics manufacturers. Learn more at batchbuddy.ai.

FOR IMMEDIATE RELEASE
Media Contact: press@batchbuddy.ai

AUSTIN, TX — BatchBuddy, a GMP-aligned manufacturing operations platform for supplement, food, and cosmetics manufacturers, today announced its public launch. The company was founded in Austin, TX in 2024 by Kelly Hackett, a career supplement formulator and GMP facility operator, and Cholee Hackett, a self-taught engineer who built the first working version of the platform over a single weekend as a birthday gift for her husband.

That first version — a functional electronic batch record system — is now a full manufacturing operations platform with formula management, potency-based scaling, AI-powered compliance assistance, cryptographic audit trails, and FSMA 204-ready traceability. BatchBuddy replaces the combination of spreadsheets, paper batch records, and legacy ERPs that most small and mid-size manufacturers still rely on, at a starting price of $149/month with no implementation fee.

The platform targets a segment of the market that enterprise vendors have historically underserved: manufacturers doing serious volume who cannot afford the $50,000–$250,000 implementation costs of legacy systems like TraceLink, MasterControl, or SAP. BatchBuddy is designed to be operational within 24 hours of signup.

"Kelly spent years running a facility with nothing but spreadsheets and paper," said Cholee Hackett, CTO. "I saw how much time he lost every week to systems that weren't built for what he was actually doing. So I built one that was."

"The software that exists in this space was built by people who never ran a batch," added Kelly Hackett, CEO. "We built BatchBuddy from the inside — from the floor of a GMP facility — and it shows."

BatchBuddy is available today at batchbuddy.ai. Plans start at $149/month with a 14-day free trial and no credit card required to start.

BatchBuddy is a GMP-aligned manufacturing operations platform built for supplement, food, and cosmetics manufacturers. Learn more at batchbuddy.ai.