Electronic Batch Records

Complete production records compliant with 21 CFR 211.188. Each record includes operator, QA release signature, raw materials used, per-step valve actions, alarms, and deviations.

Figure 8.1 · Electronic batch records · list on the left · detailed production record on the right

21 CFR 211.188

Batch production and control records. Append-only storage, retained 7 years. All electronic signatures comply with §11.100(b) and cannot be removed from the record.