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An example of how the FDA guideline from title 21 CFR Part 11 applies to Packaging Line Automation Machinery – Robotic Tray Packer

What is 21 CFR PART 11? 21 CFR Part 11 is a section in the Code of Federal Regulations (CFR) that sets out the United States [...]

By | November 8th, 2016|Automation Tips, News & Blog, Pharmaceutical|Comments Off on An example of how the FDA guideline from title 21 CFR Part 11 applies to Packaging Line Automation Machinery – Robotic Tray Packer

GAMP 5 Software categories

In the GAMP 5 guidelines, there is a system for Categorising Software applications ranging from Category 1 up to category 5 (1 being infrastructure software such [...]

By | February 21st, 2015|Automation Tips, Pharmaceutical|0 Comments