GXP

Electronic Records Lifecycle

The MHRA Data Integrity Definitions and Guidance provides a wide data related terminology use in support to this guidance.

The MHRA definitions are consistent to with other regulatory agencies similar terminology, including the Volume 4, EU Good Manufacturing Practice Medicinal Products for Human and Veterinary Use.

Based on a fully integrated enterprise and process control environments, these definitions are explained related with where the electronic records were originated and transferred.

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