Review of Data Integrity in Pharmaceutical Industry

Abstract

Data integrity has been in the world for a quite some time. In the pharmaceutical industry, it has been playing a major role in ensuring the correctness and truthfulness of the data. The industry has been upgrading the technologies for the production of drugs, storage and distribution. In the past, the man-made workforce has been upgraded to the machine that too Artificial Intelligence machine, computers etc. In such a case integrity of data is utmost priority for ensuring correctness. Machine and the computer are built to reduce the work- force and make the work convenient for workers. It is helpful in reducing the time load of work but to ensure the honesty of the work; data integrity came into effect. A company which runs with the full GMP regulations will get less warning letter during the audit trials, but a company with proper GMP as well as proper implementation of data integrity will percolate into the audit trials successfully. Ensuring data integrity will help the firm to acquire a smaller number of warning letters or form 483. Efficacy; quality and safety of the drug can be easily achieved by data integrity. Data integrity has revolutionized the pharmaceutical industry. Terms such as ALCOA ALCOA+ plays a major role in the integrity of data and been used by various regulatory agencies such as FDA MHRA etc.