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← Document libraryBatch Record Review
Fictional document for the demonstration.
§6.1 Review before release
The batch record is reviewed in full by Quality Assurance before release. A batch cannot be released with an open entry.
§6.2 Second-person verification
Critical steps, including weighing and dispensing, require a second-person verification signed in the batch record at the time of the operation. A missing verification is a deviation and the batch is held until it is resolved.