Abstract

REVIEW ON 21 CFR PART 11 IN PHARMACEUTICAL INDUSTRY

Shruti Chougule*, Sayali Pawar, Dr. S. S. Tanavade and Dr. K. A. Wadkar

ABSTRACT

This review aims to identify ways for complying with the Food and Drug Administration's (FDA) regulation 21 CFR part 11 on electronic records and signatures, as well as realising the organisational benefits that can be gained by using electronic records. The document begins with a background chapter that includes an introduction to the FDA, the history of the rule, and a summary of the decision. The ruling's many requirements are classified and described under a number of topics. In the framework of the regulation, two of the tools utilised to accomplish compliance, system validation and risk management, are studied. A multi-step compliance framework is created, focusing on both the technical and organisational aspects of compliance.

Keywords: FDA, organizational change, 21 CFR part 11.