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HCL Technologies

Design History File Remediation for Therapeutic product

Design History File Remediation for Therapeutic product

The DHF is a set of documents or records that is used for demonstrating the drug product is designed and developed in accordance with Good Manufacturing Practice (GMP) requirements and design control requirements as per regulations and most of the DHF documents are considered as living documents. Design History File is a part of Safe Medical Devices Act introduced by U.S. Congress with the intention of setting new standards for medical devices that can cause or contribute to the injury, serious illness or death of a patient. The Design History File is a core requirement set out by the U.S. Food and Drug Administration (FDA); its counterparts, the Technical File and Design Dossier are required for the EU's regulatory body.

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