Batch records overview

A batch record is the documented, step-by-step history of a single production run. It is how regulated manufacturers — food, cosmetics, supplements, and other cGMP/FDA-governed products — prove a batch was made correctly.

Why batch records matter

Where a work order tracks what you made and how much, a batch record tracks how you made it: the procedure followed, the materials and lots used, in-process checks, and who signed off at each step. This gives you an audit trail for quality reviews, recalls, and inspections.

How it fits together

1. You build a reusable master batch record that defines the procedure for a product.
2. When you run production, Fiddle creates an issued batch record — a working copy for that specific batch.
3. Operators follow the steps, record actual quantities and measurements, and capture sign-offs.
4. The completed record is reviewed, signed, and locked as a permanent document.

A batch record is a controlled document. Once signed and closed it should not be edited — corrections are made through a documented amendment, never by overwriting.

What a batch record captures

Element	Purpose
Procedures	The ordered manufacturing steps to follow
Materials & lots	Exactly which lots were consumed, for traceability
In-process checks	Measurements and quality gates during the run
Sign-offs	Who performed and who verified each step

Next steps

Start with procedures, then build a master batch record.