Using Electronic Batch Records (EBR) to Optimize Manufacturing Efficiency

In an effort to ensure product quality and patient safety, the pharmaceutical and biotech industries are governed by strict regulations. As part of these regulations, the FDA requires that detailed production records be kept for each batch of a product produced by a pharmaceutical company. These records need to be accessible to regulators and can be used to confirm that raw material inventory is properly controlled, relevant procedures have been followed, necessary quality checks have been performed, and employee identities and training levels are verified.

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