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Attributable Data Integrity in Modern Biopharma Using ALCOA Principles
This article is the first in a five-part series providing contemporary, practical, and useful examples of data integrity within each of the five.
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Data integrity
Compliance with drug
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The Data Integrity Body of Knowledge Expands with New Pending Guidances
Some of the contemporary guidance documents for data integrity in biopharmaceuticals and medical devices, both released and in draft, are explained.
United states
United kingdom
International society for pharmaceutical engineering
Inspection co
Expert committee on specifications for pharmaceutical preparations
European union
World health organization guidance
International conference on harmonisation
Drug administration
World health organization
European commission
Regulatory agency
Inspection convention
European medicines agency
Health canada
Expert committee
The Data Integrity Body of Knowledge Expands with New Pending Guidances
Some of the contemporary guidance documents for data integrity in biopharmaceuticals and medical devices, both released and in draft, are explained.
United states
United kingdom
International society for pharmaceutical engineering
Inspection co
Expert committee on specifications for pharmaceutical preparations
European union
World health organization guidance
International conference on harmonisation
Drug administration
World health organization
European commission
Regulatory agency
Inspection convention
European medicines agency
Health canada
Expert committee
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