In the first part of this article1 we discussed the GAMP Good Practice Guide (GPG) for the Validation of Laboratory Computerized Systems.2 We looked at the advantages offered by the System Implementation Life Cycle (SILC) in contrast to the complexity of the system classification proposed in the GPG.
In this part I'll look at the risk assessment methodology, the new US Pharmacopeia (USP) general chapter <1058>,3 which is based upon the AAPS analytical equipment qualification white paper,4 and suggest a way forward to unite the qualification of equipment with the validation of the controlling laboratory computers.
Risk Assessment Methodology
Figure 1: GAMP GPG risk management process.
OK, if you managed to get this far after reading Part 1, we now have the finishing touch — the risk assessment methodology. GAMP 45 uses a modified Failure Mode Effect Analysis (FMEA) risk assessment methodology as outlined in Appendix M3.3 This has also been adapted for laboratory systems in the GPG. Why this over complex methodology was selected for laboratory systems is not discussed although I suspect that it is aimed at consistency throughout the GAMP series of publications. The overall process flow for the risk assessment is shown in Figure 1: the first three steps are at the system level and the last two at the individual requirement level.
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