ולידציה -Testing and HW/SW Type and Maturity
ולידציה -Testing and HW/SW Type and Maturity - GAMPProcess automation systems generally comprise several elements. Categorizing these elements according to t…
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ולידציה -Testing and HW/SW Type and Maturity - GAMP Process automation systems generally comprise several elements. Categorizing these elements according to those described in GAMP 4 can assist in targeting testing and validation effort. Some functional elements may be fully contained within the system standard packages or firmware (FW), while others may require different degrees of configuration or customization. In general, the greater the degree of customization, the greater the scope of testing required. For example, if an item of the process equipment is to be controlled, the User may have several options for implementing the process control system functional element. : Typical Test Phases for Process Automation Systems Complex control exists as single, mature 'equipment level' library module, where functions can be selected/ deselected and setup parameters entered For example, sterilizer module with selectable cycle types Application Life Cycle Testing: selection of functions, setup parameters :Typical Test Phases FAT and /or SAT IQ /OQ/PQ of process equipment Complex control built up from mature, interlinked 'device level' library modules, which must have correct parameters entered For example, sterilizer control, built up from valve, motor, PID, set-point program modules. Application Life Cycle Testing: selection and linking of modules functions to give correct functionality, setup parameters :Typical Test Phases FAT SAT IQ /OQ/PQ of process equipment Complex control built up from application specific modules, themselves built up from low-level library modules, or from simple coded steps within a predefined structure. For example, sterilizer control configured in ladder logic Application Life Cycle Testing: functionality of custom coded modules, selection and linking of modules functions to give correct functionality, setup parameters :Typical Test Phases Module test FAT SAT IQ /OQ/PQ of process equipment Complex control custom added For example, sterilizer control coded in C++ Application Life Cycle Testing: functionality of custom coded modules, interaction between custom coded modules, selection and linking of modules functions to give correct functionality,setup parameters. :Typical Test Phases Module test Module integration test FAT SAT IQ /OQ/PQ of process equipment :Notes The suggested test phases listed above are typical only; they may be increased or decreased to reflect the complexity of the application, and the impact on product quality, patient safety and data integrity The above assumes mature, 'industry proven' library modules. If these are created specifically for the application, then they need to be treated as custom code Smartlogic expertise in validation of current and new systems to meet the most rigid requirements of the FDA and CFR protocols.