The data becomes one of the most valuable assets of any organization but without integrity, this data is not much useful. Data integrity (DI) is assuring the accuracy and consistency of data over its entire life-cycle and it is an important current issue for regulatory bodies around the world.
Only when data is reliable can drug manufacturers make the best suitable choices for their organizations, improve the quality of their products and contribute to their overall success. In this relation, DI helps to ensure that data in an organization is accurate, complete, consistent, and trustworthy throughout the lifecycle of the product.
FDA expects that all data be reliable and accurate. CGMP regulations and guidance allow for flexible and risk-based strategies to prevent and detect data integrity issues. Firms should implement meaningful and effective strategies to manage their data integrity risks based on their process understanding and knowledge management of technologies and business models.
Importance of Data Integrity
- Data integrity mitigate and minimize the risks and helpful for decision making.
- Data records are the only proof that your production process is performed according to the quality standards.
- Companies can only prove the quality of their products by showing data produced during their production processes.
Reference:
- FDA Data Integrity and Compliance with Drug CGMP
- International Society for Pharmaceutical Engineering (ISPE)
