Validation of Chromatography Data Systems: Meeting Business and Regulatory Requirements

Chapter 24: CDS System Retirement

The final stage in the life cycle of a CDS is the retirement of the components of the system.

24.1 What do the Regulators Want?

There is again nothing formal or implied in the GLP or GMP regulations about what is needed when retiring or decommissioning a chromatography data system or indeed any computerised system used in a controlled environment.

Often system retirement is a euphemism for either throwing the components out of the organisation or donating the items to an educational institution. There needs to be a more structured process where the components have documented evidence of their removal from operational service.

24.2 Generic Process for System Retirement

The overall process flow for system retirement is shown in Figure 45, the involvement of both management and quality assurance in the process is a critical success factor.


Figure 45: Process flow for system retirement

24.2.1 Notification of System Retirement

There needs to be a formal notification that the old CDS will be retired. This is important as there needs to be continuity and co-ordination between the old system being retired and the new CDS being installed, qualified and becoming operational. There can be no gaps in service support as chromatography in most laboratories is a major analytical technique. Therefore, there needs to be an orderly transition between the two systems and work that is ongoing is smoothly transferred to the new CDS.

Continuity of laboratory operations is important as there is typically never a good time to transfer between systems.

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