Tagged with: FDA

21CFR11 FDA electronic records

The purpose of Part 11 is to provide criteria for acceptance of electronic records and signatures by FDA. It is intended to permit the use of a wide array of electronic technology that is consistent with FDA’s mission to protect public health and safety. Electronic records and electronic signatures must have at least the same authenticity, integrity, trustworthiness, and reliability as paper records and handwritten signatures...

Drug Safety Introduction

Costs of illness due to adverse effects of drugs is estimated to 117.4 billion ($ 117.400.000.000) in 2000 for the United States alone (Ernest and Grizze, 2001). It is hard to comprehend the magnitude of this number, but it is only the financial side of the problem. It is estimated that up 98.000 American die every year due to drug related events an unknown number of patients experience additional suffering and injuries (2).

Inspection Checklist

The drug safety function needs to be continuously ready for inspections by the authorities. A wide range of items have to be considered and documented before an inspection. The details are described in this article.

Quality Management System

A formal Quality Management System (QMS) is now being expected for a drug safety function in the pharmaceutical industry. The QMS focus on the organizations ability to ensure stable processes which are continuously monitored and improved.