The CAMSTAR InSite MES 1.

3 validation verified that the software version has been installed and operates in conformance to Cordis LLC, manufacturer specifications, users and systems specification. During the validation effort the system operational consistency, hazard avoidance and alarms were verified. All the conditions were tested by submitting the MES to different simulated test scenarios using production data generated during the base and top coat phase of the stent manufacturing process. The CAMSTAR InSite MES 1.3 Application Software was composed of a group of majoroperational modules that runs a sequence of production tasks and activities, collects and monitors manufacturing process parameters, measures and analyzes parameters in relationship to their acceptable limits and variance levels, and alerts management of out-of-control processing conditions as they occur

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To obtain objective evidence, that the MES Software Version 1.2 has been installed and operates in conformance to Cordis LLC, manufacturer specifications, users and systems specification. 1.1.2 To obtain objective evidence, that the MES 1HT operation will consistently produce the expected outcomes per the 657.Coating1HT.RS8. 1.1.3 To obtain objective evidence, that the MES provides a sufficient degree of hazard avoidance. The Manufacturing Execution System (MES) Application Software is composed of a group of major functional units and / or operational modules that runs a sequence of production tasks and activities, collects and monitors manufacturing process parameters, measures and analyzes parameters in relationship to their acceptable limits and variance levels, and alerts management of out-of-control processing conditions as they occur