Electronic Batch Records for Photopolymer Production: Data Capture, Recipe Enforcement, Exceptions and Auditability

An electronic batch record should capture the executed material, equipment, recipe version, operator actions, timestamps and measured results. A system may record that an operator entered a value without preventing an invalid value. Skipped steps, manual overrides, equipment alarms, repeated measurements and rework should not disappear into free-text comments. For regulated electronic records, the ability to reconstruct who changed what and when is fundamental. Balances, spectrometers, printers and cure chambers may each generate primary data. Qualification therefore depends on preserving the measured state, configuration and exception history needed to distinguish these mechanisms in production rather than relying on nominal recipe identity alone.

ER-349.