PIC/S update to PE009 – version 14 on its way
In a recent press release, the PIC/S Committee recently announced the revision of the PIC/S GMP Guide (PE 009) to PIC/S version 14, with updates to:
Chapter 3 – Premises and Equipment
Chapter 5 …
Quality Risk Assessment
In Australia, a Quality Risk Assessment is now a regular GMP activity since we saw the introduction of PIC/S Version PE 009-08, in 2009 (read more here) and the massive impact, especially of the two …
White Paper – Comprehensive Review and Implementation of Risk Management Processes in Software Development
This paper reviews the principles of risk management in software development of GxP systems, elaborates on the well-known risk management approaches and identifies some of the important concepts of proactive management of risks throughout the software development lifecycle.