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GAMP 5

sayeed@sayeed
11 Posts
#1 · September 24, 2024, 12:00 am

What are the categories of CSV as per GAMP 5?

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Chief Pharmacist@pharmato
33 Posts
#2 · September 25, 2024, 3:42 pm
  • Category 1 - Infrastructure Software (includes operating systems, database management systems, and network infrastructure components)
  • Category 3 - Non-configured Software (includes commercial off-the-shelf (COTS) software packages that are used without configuration or with minimal configuration)
  • Category 4 - Configured Software (includes software that is configured to meet specific user requirements)
  • Category 5 - Custom Software (includes custom-developed software applications specifically designed for a particular pharmaceutical process or system)
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Last edited on September 25, 2024, 3:42 pm by Chief Pharmacist
sayeed@sayeed
11 Posts
Topic Author
#3 · September 28, 2024, 4:17 pm

Why Category 2 is missing in GAMP 5?

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Chief Pharmacist@pharmato
33 Posts
#4 · September 28, 2024, 4:26 pm

@sayeed

Category-2 is related to firmware. At the time that GAMP4 was issued firmware was considered to be used for simple instruments. However as technology has advanced the it has been recognized that complex software can be embedded (firmware) within systems.

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