Data Integrity in the Pharmaceutical Industry

Abstract

Data should have consistency, completeness, accuracy which is the main requirement of data integrity. Safety of data is abeyance of—GDPR (General Data Protection Regulation) compliance – and security should be followed to regulatory compliance then such data become data integrity. It is maintained by a collection of processes, rules, and standards implemented till the finish product/drugs. Presently, the most discussed topic in the pharmaceutical/healthcare industry is the Data Integrity. Pharmaceutical giants collapsed due to data integrity issues. The senior management of the organizations should take data integrity issues seriously and work on how to resolve them to avoid destructive things in terms of business, reputation, trust, market value and many others by getting warning letters or noncompliance reports issued from the regulatory agencies. This will provide information about data integrity, regulatory requirements of data integrity, consequences of data integrity issues, steps to be taken to prevent data integrity issues and discussion on warning letters issued by regulatory authorities with graphical representation.