How Audit Trails ensure Accuracy in clinical trails ?

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...

What is Computer system Validation and Role of CSV specialist

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...
DATA INTEGRITY IN PHARMA – ALCOA  CONCEPT

DATA INTEGRITY IN PHARMA – ALCOA CONCEPT

What is ALCOA? If this is the question in your mind then we are ready to answer your question this is one of the questions being asked when thinking of joining QA and some other departments as data integrity is very important in manufacturing, research, etc. Nowadays...

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