Risk Management – A Continuous Process

Introduction
As discussed in previous posts the regulatory expectation is that risk management will be applied to all lifecycle phases of a computerised system. The recent issue of EU Annex 11 includes risk management at all stages of the computer system lifecycle.

GAMP 4 first introduced the concept of risk management and risk assessments and following the issue of the ASTM E52500 Specification

Read More

FDA Warning Letters - Risk Assessments

IntroductionAlthough to date I have not found any references within the FDA warning letters directly relating to computerised systems and risk assessments within the pharmaceutical / biotechnology industry it is interesting to review inspection findings where risk assessments have been detailed.

In this post there is a review of two FDA warning letters which reference the use of documented risk

Read More

Applying Computer System Security (GAMP)

It is a regulatory requirement that access to computerised systems is limited to authorised users. This not only limited to systems that contain electronic records but all systems that are used to fulfil regulated activities.

This post focuses on the FDA and MHRA / EU requirements regulatory requirements for security management of computerised systems within the pharmaceutical and biotech

Read More