DATA INTEGRITY IN PHARMA: A CRUCIAL IMPERATIVE

Rajpure Pranjal Madhukar*, Devade Omkar Ashok, V. K. Redasani and Kadam Shruti Sunil

ABSTRACT

Data integrity is of paramount importance in the pharmaceutical industry to ensure the safety, efficacy, and quality of products. This review article explores the challenges faced by pharmaceutical companies in maintaining data integrity throughout the product lifecycle, from research and development to manufacturing and distribution. It discusses the regulatory requirements, including guidelines from regulatory bodies such as the FDA and EMA, and highlights the consequences of data integrity breaches. Furthermore, the article examines various strategies and technologies available to mitigate these challenges, including the implementation of robust data management systems, training programs for personnel, and the use of advanced analytical techniques. By addressing these challenges proactively, pharmaceutical companies can uphold data integrity standards and safeguard public health. Terms such as ALCOA, ALCOA+ plays a major role in the integrity of data and been used by various regulatory agencies such as FDA, MHRA etc.

Keywords: USFDA, Data Integrity, ALCOA, Regulatory Body.