We take a pretty pragmatic approach to system validation while delivering most effective web based monitoring systems. Essentially, you provide us with a simple User Requirements Document (URS). We then fill in one of our validation templates to create a System Design Specification (SDS) that meets the user requirements. In conjunction with this, we use another template to create an Installation Qualification (IQ) protocol containing sections for all the hardware and software, system configuration, availability of SOPs, etc. Since most of the work related to these documents has already been done, the effort required to customize them for your application is minimal.
Before a new version of the SmartScan server software is released, it is exhaustively tested (formally validated). In conjunction with this, we create, execute, and document a server software OQ and supply it to our customers for use in their validation package. The tests for the OQ are conducted using a standard set of remote hardware. Since all measurement data enters the SmartScan server through a single portal and in a common message format, this hardware set can be used to completely verify the operation of the software.
Finally, we create a Performance Qualification (PQ) protocol based on the SDS and IQ. The PQ is executed after the system has been installed and is fully operational to make sure that the remote devices are correctly linked to the server and the measurement data is being stored for each sensor. It is also used to verify that abnormal conditions are properly detected and the appropriate alerts generated.
Formal Calibration Certificates or Certificates of Compliance are provided for all sensors. Certificates of Compliance are also provided for all the remote data acquisition hardware. Formal Validation Documents for all our hardware are available for inclusion in a customer’s validation package if necessary.
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