Podcast
Questions and Answers
Maintaining data governance and data integrity is not essential for compliance in the pharmaceutical industry.
Maintaining data governance and data integrity is not essential for compliance in the pharmaceutical industry.
False
ALCOA+ standards only focus on electronic records in pharmaceutical organizations.
ALCOA+ standards only focus on electronic records in pharmaceutical organizations.
False
Quality control (QC) laboratories do not play a crucial role in assuring the quality and safety of pharmaceutical products.
Quality control (QC) laboratories do not play a crucial role in assuring the quality and safety of pharmaceutical products.
False
The FDA has never observed noncompliance related to data integrity and governance in the pharmaceutical industry.
The FDA has never observed noncompliance related to data integrity and governance in the pharmaceutical industry.
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The European Medicines Agency (EMA) does not establish rules related to data integrity for pharmaceutical organizations.
The European Medicines Agency (EMA) does not establish rules related to data integrity for pharmaceutical organizations.
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The FDA's 2018 document on Data Integrity and Compliance With Drug CGMP is no longer considered valid as of January 2024.
The FDA's 2018 document on Data Integrity and Compliance With Drug CGMP is no longer considered valid as of January 2024.
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The ALCOA+ principle refers to ensuring data security through availability, longevity, and traceability of data records.
The ALCOA+ principle refers to ensuring data security through availability, longevity, and traceability of data records.
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The World Health Organization (WHO) did not follow the FDA's guidance on Data Integrity and Compliance with CGMP.
The World Health Organization (WHO) did not follow the FDA's guidance on Data Integrity and Compliance with CGMP.
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The FDA defines data integrity as the permanence and accuracy of electronic data only.
The FDA defines data integrity as the permanence and accuracy of electronic data only.
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Global knowledge about data-integrity standards has led to fewer regulatory gaps in the pharmaceutical industry.
Global knowledge about data-integrity standards has led to fewer regulatory gaps in the pharmaceutical industry.
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