ALCOA+ and Data Integrity

March 15, 2020
Susan J. Schniepp
Susan J. Schniepp

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Pharmaceutical Technology, Pharmaceutical Technology-03-15-2020, Volume 2020 eBook, Issue 1
Page Number: 10-13

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.

Article Details

Pharmaceutical Technology
eBook: Regulatory Sourcebook, March 2020
March 2020
Pages: 10–13

Citation

When referring to this article, please cite it as S. J. Schniepp, “ALCOA+ and Data Integrity," Pharmaceutical Technology Regulatory Sourcebook eBook (March 2020).