Back to BatchBuddy ✅ QMS | MANUFACTURER + ENTERPRISE

Quality that runs
itself. Because
it's structural.

Most QMS tools are checklists. BatchBuddy's quality system is integrated into every production step. Operators cannot close a batch without completing required checks, and training status is enforced before a run begins.

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Training Matrix

Real-time operator qualification status. Blocks production if any required training is lapsed.

CAPA System

CAPAs linked directly to batch deviations and OOS events. No manual cross-referencing.

COA Generation

Certificates of Analysis auto-generated from batch test results. E-signature ready.

OOS Investigations

Out-of-spec results trigger structured investigation workflows, not just email threads.

Quality Events Are Documented Automatically

Every deviation, every investigation, every CAPA is linked to the batch that triggered it, with a tamper-evident audit trail.

Operator qualification enforced at run start

If any operator on a run has expired training for a required SOP, the system blocks production. Not a warning. A hard stop.

CAPA auto-linked from yield anomaly flags

When YieldGuard™ flags a deviation, a CAPA record is pre-populated with the batch reference, lot number, and deviation data. Your QA fills in the root cause.

COAs generated from batch test data, not typed manually

Enter test results once. The COA populates automatically with spec pass/fail, lot details, and is e-signature ready for release.

Quality Module Coverage

Training Records & Matrix

Manufacturer+

CAPA & OOS Investigations

Manufacturer+

COA Generation (single & bulk)

Manufacturer+

Electronic Batch Records

Enterprise

Yield Anomaly Detection

Manufacturer+

Operator Qualification History

Manufacturer+

Process-Loss Step Tracking

Manufacturer+

API-driven COA automation

Enterprise

Quality that prevents failures, not just documents them.

Start a Manufacturer trial and the full quality suite is active from day one.

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Quality that runsitself. Because it's structural.

Quality Events Are Documented Automatically

Quality Module Coverage

Quality that prevents failures, not just documents them.

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Quality that runs
itself. Because
it's structural.