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What is GAMP5?

GAMP 5 (GAMP®5), or ‘Good Automated Manufacturing Practices’ is a non-mandatory legislation for pharmaceutical and food companies. It provides important guidelines for companies involved in the development and/or implementation of automated systems.

In essence, GAMP 5 refers to a structured approach for the validation of automated systems. The 5th version of GAMP puts more emphasis on risk management and quality management. There is currently no 6th version in the works. Companies that apply the GAMP 5 guidelines can ensure the quality of their automated systems. It also makes it easier to pass audits and government inspections.

Do you have any questions about Gamp 5 or MES?
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Read more blogs about MES

IT and OT in the industry: ensure separation & collaboration

IT and OT in the industry: Ensure separation & collaboration

In summary, you can say that the speed of change within IT is much higher and that OT is still very unknown within IT. OT cannot change as quickly as IT and the OT landscape...
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MES in practice: “The importance of management processes is often underestimated”

The importance of good management processes for Manufacturing Execution Systems, or MES for short, is often underestimated. I've seen several situations where that led to problems. In a MES project a few years ago, I...
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The difference between IT and OT

The difference between IT and OT

The difference between IT and OT is best explained with different levels of automation. The IT and OT domains each span different levels and have their own focus areas and priorities. The different levels of...
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