Abstract

AN ILLUSTRATIVE REVIEW ON THE IMPORTANCE OF ELECTRONIC DATA HANDLING IN PHARMACEUTICAL INDUSTRY

Dr.Vijaya Barge, *Mr. Abhilash Bhosale, Ms. Shubhangi Darekar

Abstract

In pharmaceutical quality system, data integrity is a key issue that needs to be addressed in a functionalized manner and its importance is directed towards each and every aspect of is quality system. Data integrity is the extent to which all data are consistent, complete and accurate throughout the life cycle of data. It should be noted and emphasized upon that data integrity requirements apply equally to manual (paper) and electronic data in a consistent manner. Electronic information includes various components such as emails, adverse event reports, complaints, batch records, quality control records – everything that is stored electronically. In this review we have focused on the various aspects of electronic data handling along with strategies available for data compliance and effective management.

Keywords: Electronic data, Data integrity, Electronic records.