Supplement batch record software: do you need it, and which option fits a small maker?
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Does a small supplement maker need batch record software yet? What 21 CFR 111 asks of the records and how six software routes compare, read November 1, 2026.
Bottom line: Not necessarily yet. The dietary supplement rule requires a batch production record for every batch but lets records be kept as originals, true copies or electronic records, and it names no software. Software earns a look when record volume, signers or outside requests outgrow paper, and electronic records must meet 21 CFR Part 11.