Batch production records with a gated QA release

What it does

Every batch runs against a specific approved formula version, with steps, ingredient consumption, in-process checks, and batch testing recorded as the batch happens, not reconstructed afterward.

Second-person verification is enforced by role: whoever verifies a step cannot be the same person who performed it. Release is gated on nine checks, including any open blocking quality event; bypassing a blocker requires the elevated override permission and a reason recorded in the audit trail.

What's in it

• Batch lifecycle with steps, consumption, in-process checks, and batch tests.
• Second-person verification enforced through separate verify and production permissions.
• Nine-point QA release gate with signed, reasoned override.
• Potency-adjusted dispense math from the operator-confirmed assay.
• Per-lot reserve sample records with disposal tracking under 21 CFR 111.83.

Primary sources

• 21 CFR 111.83: reserve samples

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