OLENA CHERVONENKO
Associate Director Quality Management & Compliance, PharmaLex

Abstract

Data integrity has emerged as a crucial topic in the pharmaceutical sector, spanning various areas such as pharmaceutical development, clinical trials, manufacturing, and quality control. This article highlights the significance of data integrity and its impact on ensuring the quality, efficacy, and safety of medicines. It emphasizes the need for the Pharmaceutical Quality System (PQS) to analyze and monitor data integrity throughout the product lifecycle. The ALCOA+ principle, encompassing attributes like attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available, is introduced as a reference for data integrity. Additionally, the article emphasizes the importance of conducting a Data Integrity Risk Assessment (DIRA) to identify and mitigate risks, along with the validation and control measures for computerized systems used in GxP-relevant environments. It concludes value for self-inspections and external assessments to ensure compliance with data integrity guidelines.

The Universe of data, its integrity and necessity
The world around us provides us with an abundance of data at every moment of every day and we constantly analyze this data to make decisions. In this process, the attributability, accuracy, legibility, permanence, contemporaneousness, and originality of the data we receive are of utmost importance.

So, what does “data” mean? Data is a formalized representation of information suitable for communication, interpretation, or processing, according to ISO/IEC 2382:2015. Data integrity is the property of data where accuracy and consistency are preserved regardless of changes made, according to the same ISO/IEC standard.

Pharmaceutical companies heavily rely on data for their business operations. From pharmaceutical development and preclinical research to clinical trials, manufacturing and the registration dossier, data sets play a crucial role in ensuring the quality, efficacy, and safety of medicines, as well as building trust in the brand. The Pharmaceutical Quality System (PQS) plays a vital role in analyzing data integrity.

A significant ...