Data Archives - QualityHub

MedCon 2026: FDA Official Reminds MedTechs They’re ‘Ultimately Responsible’ for Submitted Data

April 27, 2026

FDA official Josh Nipper warned medical device companies at MedCon that they remain fully accountable for the accuracy and integrity of all data submitted for

‘Tip of the Iceberg’: Data Integrity a Front-and-Center Concern for FDA, QHub Expert Says

May 1, 2025

The FDA has uncovered widespread data integrity issues in medical device submissions, particularly from third-party labs, including two in China. As a result, the agency

QHub Insights║Data Integrity and Good Documentation Practices in the Life Science Sector

February 15, 2023

Data integrity in FDA-regulated industries is ensured by following Good Documentation Practices and ALCOA+ principles, which require records to be accurate, complete, attributable, and secure