Data Integrity for Pharmaceutical Grade Excipients

In April 2020, IPEC released a position paper describing its position on the relevance of data integrity guidance documents to the manufacture and supply of excipients. “Maintaining data integrity is fundamental to the application of GMP. Published regulatory...

Audit Trail Reviews of Electronic Health Records

Are You Managing Your Electronic Health Records Properly? According to the ECA Academy, MHRA inspectors have recently noticed several major findings during their inspections.  Issues have been noted with audit trails, access and security, scanning and certified...

FDA’s New Data Integrity Guidance — Highlights & Observations

The scope of the FDA document includes drugs, biologics, and positron emission tomography drugs. The agency also states the requirements are consistent with the requirements in ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, thus...