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Data supporting the quality and safety of product must meet the ALCOA+ elements in order to avoid regulatory citations for data integrity issues.
Data supporting the quality and safety of product must meet the ALCOA+ elements in order to avoid regulatory citations for data integrity issues.
Read this article in Pharmaceutical Technology’s March 2020 Regulatory Sourcebook.
Pharmaceutical Technology
eBook: Regulatory Sourcebook, March 2020
March 2020
Pages: 10–13
When referring to this article, please cite it as S. J. Schniepp, “ALCOA+ and Data Integrity," Pharmaceutical Technology Regulatory Sourcebook eBook (March 2020).