It’s late, do you know where your data is? Are you really sure? Would you be able to assure a regulatory agency that you fully understand and control the flow of data from data generation through processing, reporting, data review, archive and retrieval? If the answer to all the above questions is yes, congratulations! Unfortunately,
Data integrity issues have cost pharmaceutical and healthcare companies millions of dollars in direct and indirect costs and led to potential risks to patient safety. Companies are in a frenzy responding to regulatory citations and preparing for inspections. The industry, mostly from “lessons learned”, generally understands the issues; and the regulatory expectations have been communicated through a number of recent guidances (drafts,
The integrity of all GxP data used to ensure the quality and efficacy of drugs is paramount to a drug’s safety and efficacy and can have a great impact on public health. To that point, the MHRA has published a draft version for consultation of a guidance titled “MHRA GxP Data Integrity Definitions and Guidance for Industry” This draft is intended to update and broaden the scope of the existing March 2015 “MHRA Data Integrity Definitions and Guidance for Industry” to all GxP data.
The integrity of data used to ensure the quality of drugs is paramount to a drug’s safety and efficacy and can have a great impact on public health. The topic of “Protecting and Promoting Data Integrity” was presented by Kathleen Culver from FDA (Field Investigator and Drug Preapproval Manager, FDA Cincinnati District), Tracy Moore (Senior GMDP Inspector and GMDP Operations Manager, MHRA), and Paul Vogel (Chairman, Lachman Consultant Services, Inc.) at the recent PharmaLink Conference, which was co-sponsored by Xavier Health and the FDA, held on March 16-17, 2016 in Cincinnati, Ohio.