Testing and Qualification of the LIMS

TESTING AND QUALIFICATION OF THE LIMS Supplier Testing Process 

The summary report will identify any issues raised during integration testing, and the pharmaceutical manufacturer will need to review this information to determine if the LIMS is fit for purpose and therefore suitable for IQ. Confirmation of acceptance of the LIMS will normally be given only if all but minor issues have been resolved. 

Installation Qualification, as its name suggests, is a process designed to confirm the integrity of the LIMS installation against the design, agreed as part of DQ. IQ should cover all aspects of the hardware, software, documentation, environment and infrastructure for the installed LIMS. 

Clearly, before IQ can commence, the component parts of the LIMS must be installed in their final location and the appropriate integration/in-terconnections completed. At the point that IQ is executed, it is essentially indicating that there is no further need to modify the physical system. 

It is essential that the integrated project team he aware of the contents of the IQ Protocol to be used, which will ensure that there are no surprises when this execution takes place. 

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