- 11/18/2020 - PRCHEM 2020
PRIM-20-07 VIRTUAL BASIC UNDERSTANDING OF DATA INTEGRITY FOR REGULATED INDUSTRY
PRIM-20-07 VIRTUAL 06/30/2020 de 8:00AM a 11:45PM
Ing. Carlos Urrutia
Pharmaceutical, Medical and Biotechnology companies should have a system for controlling their DATA and their Integrity for electronic, paper based or hybrid. Failures in data governance and data integrity have been more prominent in health authority enforcement actions in the past few years. Failures in data integrity break the essential trust that regulators have with manufactures of medicinal products. Regulatory authorities cannot review all the data that firms generate during the development and commercial lifecycle of every medicinal product. Even during inspections, they review only a small fraction of the data generated.
When regulators “Auditors” find that companies have falsified or manipulated electronic or paper data to achieve passing results – or have failed to document and investigate failing results – they lose confidence in all the data presented by the organization “firm”, a conclusion with devastating financial consequences.