2023 | November / December 2023

Data integrity in GxP relevant areas has been a hot topic in the pharmaceutical sector in recent years

by cyb2025

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.

ABOUT THE AUTHOR

Olena Chervonenko is an accomplished professional in pharmaceutical chemistry and quality management. With a Bachelor’s and Master’s degree in Pharmaceutical Chemistry from Odesa I.I. Mechnikov National University, she began her career as a Chemist-Analyst. Olena progressed to become a Leading Specialist, implementing GMP principles and integrating quality assurance into drug development. Later, as the Head of QA and CMC RA Departments, she successfully managed quality assurance, registration processes, pharmacovigilance and business development activities. She played a crucial role in establishing a Quality Management System (QMS) and GMP certifications. Currently, she serves as Associate Director Quality Management and Compliance at PharmaLex, where she continues to contribute her expertise in quality management and regulatory compliance.

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