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Integrated Risk Management / July 2012 Risk management, as also required in GAMP 5, helps to meet compliance requirements in a focussed and efficient way. GAMP 5 suggests a five-step risk management process (GAMP 5, Appendix M3, Science Based Quality Risk Management), whereby this article focusses mainly on the last two steps of the process: Figure 1: GAMP 5 risk management process Based on the compliance frameworks (e.g. GxP, SOX etc.) and an appropriate risk analysis, controls are specified that ensure the regular review and monitoring of identified risks. In the classic approach, these controls are introduced and monitored separately for all compliance frameworks. Figure 2: Risk management for different compliance requirements www.hgp.ag © 2012 HGP AG, CH-Basel, All rights reserved Page 2 of 6
Integrated Risk Management / July 2012 Many of the controls, however, occur more or less identically in the various compliance frameworks (GxP, SOX etc.), meaning that they are checked several times in various cycles. Consequently, the introduction and maintenance of a change process as a control, for example, occurs in almost all compliance requirements. Added to this is that many controls are related to processes, which in turn apply to a variety of computer systems, e.g. the change process. Subsequently, we can therefore conclude that we have introduced appropriate risk management processes to the fullest extent possible, but that these have been implemented redundantly and at a considerable cost throughout the entire organisation due to numerous compliance requirements and their application to a number of IT systems. Generally, this leads to high yet unnecessary additional costs for the specification and implementation of the controls. It can even lead to contradictory evaluations of individual controls, as these are not standardised throughout the various frameworks and so are evaluated differently by the different departments. A lack of transparency in the actual compliance status within the organisation then also contributes to the system falling short of expectations. The desired compliance is indeed achieved, but only at considerable expense and the risk of unpleasant surprises during audits and inspections due to this complexity. Integrated Risk Management One solution for implementing these risk management processes in an efficient way into the entire organisation is the introduction of an integrated risk management system: Figure 3: Integrated risk management www.hgp.ag © 2012 HGP AG, CH-Basel, All rights reserved Page 3 of 6
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