Data integrity violations: A challenge to the pharmaceutical industry

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International Journal of Pharmaceutical Quality Assurance


Data integrity refers to data reliability throughout the data lifecycle. Terminology “ALCOA” means that the data should be attributable, legible, contemporaneously recorded, original, and accurate. “ALCOA Plus” was introduced later. Violation of the integrity of data is termed as a breach of data integrity. It can take place in various fields, but not limited to manufacturing, quality control (QC), quality assurance (QA), and research. Some of the reasons for breach in data integrity are fabrication or duplication of data, out of specification, out of trend, back-dating, manipulation of data, inadequate standard operating procedures (SOPs), common usernames, and shared passwords. A study to assess the impact of data integrity violations based on the US FDA warning letters was conducted. The majority of data integrity breaches belonged to QC. The frequency of letters based on the country has been presented in the form of a graph. China and India received the highest number of letters for breach of data integrity in the year 2018 and 2017 respectively. It can be concluded that it is important to enforce data integrity and develop strategies for the same. The study is beneficial to understand the reason, affected field of work and remediation methods for data integrity, and improve regulatory compliance.

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