JVT

Building a Quality Culture that Supports Data Integrity in the Pharmaceutical Industry

Abstract

Data integrity is a fundamental regulatory requirement in the pharmaceutical industry, assuring that trustworthy and reliable data are used for decision-making during development, manufacturing, and testing of medicinal products. Complete, consistent, and accurate data throughout the data lifecycle ensures the safety, efficacy, and quality of drugs. However, global regulatory agencies have increasingly cited pharmaceutical organizations for data integrity violations, resulting in product recalls, import bans, drug shortages, and loss of trust from healthcare providers, patients, and regulatory agencies. This paper presents an overview of data integrity, defining the requirements for data reliability, providing a description of data-related issues, potential root causes, and US Food and Drug (FDA) regulatory requirements. Furthermore, this paper explores how a pharmaceutical organization can grow a healthy quality culture that would serve as the foundation in assuring good data management practices, and ultimately providing assurance of data integrity. 

This content is only available to IVT members.
Get help maintaining your knowledge . Read More!

If you are already a member and you do not have access to this article, upgrade your membership.
Need help? Read our FAQs.




Product Added Successfully

This product has been added to your account and you can access it from your dashboard. As a member, you are entitled to a total of 0 products.

Do you want access to more of our products? Upgrade your membership now!

Your Product count is over the limit

Do you want access to more of our products? Upgrade your membership now!

Product added to cart successfully.

You can continue shopping or proceed to checkout.