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.