JVT

Ensuring Data Integrity During Validation

Most of these guidance documents describe the recommended guidelines for achieving data integrity for electronic systems in the pharmaceutical industry. Regulatory agencies have become very active in inspecting companies for compliance with data integrity requirements. Data integrity is a predicate rule requirement that applies to all GMP regulated records including validation documents, data and information. During validation, companies generate critical GMP data during the lifecycle of regulated systems. This includes process, cleaning, product and system data that is a key indicator of the...

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