by Dr. Yashashwini Reddy | Jun 30, 2024
Important Interview Questions in Computer System Validation 1. What is data integrity in CSV? Ans: Data integrity in CSV refers to the consistency and accuracy of data through its entire lifecycle and it ensures data remains unchanged and remains in its original...
by Dr. Yashashwini Reddy | Jun 30, 2024
Computer system validation, if you are thinking about starting your career in CSV, then this article will give you an overview of what CSV is, and what is the role of CSV in the Pharma industry. CSV is a critical requirement of regulatory agencies. It aims to ensure...
by Dr. Yashashwini Reddy | Jun 10, 2024
Methods in Pharmacovigilance, this article will give you an overview of the pharmacovigilance methods and the concepts involved in it. Definition of Pharmacovigilance as per WHO: science and activities relating to detecting, assessing, understanding, and preventing...
by Dr. Yashashwini Reddy | Jun 4, 2024
Drug Master File Submission Process We have discussed the types of drug master files and their purpose in the previous article now we will learn how a DMF is submitted to the FDA in short. Procedure for DMF submission Electronic Common Technical Document (eCTD): DMFs...
by Dr. Yashashwini Reddy | May 17, 2024
In this article, we are going to learn the concept of process validation in concise . Validation is an act of proving right with documented evidence, suppose you create a new password, and the system to validate your password, asks you to re-enter so that you are...
