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GAMP4 guidelines concerning the use of process simulation software

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This paper discusses GAMP4 guidelines concerning the use of process simulation software, the impact of system testing and qualification of the software on project risk mitigation, and GAMP4 requirements for suppliers of process simulation software.

By Martin Berutti, Mynah Technologies

PROCESS SIMULATION software for operator training and system testing is a valuable tool for process automation projects. Users in validated industries are interested in how the use of process simulation software is impacted by their adoption of the GAMP4 guidelines for validation of automated systems.

When used correctly, process simulation software can help companies with validated systems comply with GAMP4 guidelines by: 

• Providing more comprehensive testing of the process control system, resulting in better automation system per-formance. 
• Accelerating the System Acceptance Testing phase of a project, resulting in shorter project cycles and quicker time to market. 
• Mitigating risk by more comprehensive system testing.

File Size: 357 KB
File Type: PDF

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