by Dr. Yashashwini Reddy | Oct 18, 2024
Understanding the Difference Between Out of Trend (OOT) and Out of Specification (OOS) in Pharmaceuticals In the pharmaceutical industry, maintaining product quality and regulatory compliance is critical. Two key terms often encountered in quality control are Out of...
by Dr. Yashashwini Reddy | Oct 10, 2024
Unveiling the Role of the Analytical Quality Assurance (AQA) Department in Pharma In the world of pharmaceuticals, quality is everything. That’s where the Analytical Quality Assurance (AQA) department steps in, ensuring that every drug produced meets strict...
by Dr. Yashashwini Reddy | Oct 8, 2024
The Importance of Access Systems in the Pharmaceutical Industry In the pharmaceutical industry, maintaining stringent security, regulatory compliance, and product integrity is critical. One essential tool in achieving these goals is the use of access control systems....
by Dr. Yashashwini Reddy | Sep 22, 2024
Understanding Data Integrity and Its Importance in Pharmaceuticals In the pharmaceutical industry, data integrity refers to the accuracy, consistency, and reliability of data throughout its lifecycle. It ensures that data, whether recorded electronically or manually,...
by Dr. Yashashwini Reddy | Jul 2, 2024
What is an Audit trail? In this article, we will learn about what an audit trail is, why it is required, and the contents of an audit trail. An audit trail is a 21 CFR Part 11 compliance requirement. These 21 CFR Part 11 deals with electronic records and electronic...
