Awareness on data integrity

Data integrity means the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA). This data becomes one of the most valuable chattels of any organization but without integrity, this data is not much useful. Accuracy and original data increase the chances of stability and performance of an organization. Due to the rise in cGMP violations involving data integrity during inspections, there have been issuances of many warning letters, import alerts and consent decrees. The implementation of different guidelines and standard operating procedures for data integrity, regular internal audits or surveillances and training will pave way for pharmaceutical industries to maintain data integrity flawlessly. The better data integrity has the more ethically successful; it is likely to become growth. Poor data integrity practices and vulnerabilities undermine the quality of records and evidence and may ultimately undermine the quality of medicinal products.

Autorentext

Parimalkumar Prajapati - M.Pharm, FICS,He is working in Quality Assurance Department at BDR Pharmaceuticals International Private Limited. He has published a number of paper in national/international journals.