General overview of validation strategy for the 5 different GAMP levels

COMPUTER SYSTEM VALIDATION (CSV) SOFTWARE VALIDATION DOCUMENTATION
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Category 1: Operating System
Record version (including service pack)
Challenge OS directly by the functionality
Category 2: Firmware
IQ: Verify name, version, configuration and calibration
OQ: Test functionality
Change Control: for firmware and configuration parameters
Supplier Audit: For complex and critical applications
[FONT=Arial][SIZE=3]Category 3: Standard Software packages
Configuration limited to the environment and parameters
IQ verifies name and version
OQ tests user requirements
Category 4: Configuration Software Packages
Treat like category 5 if platform and package not mature and well-known
Category 5: Custom Software
Execute complete Validation Lifecycle
Standard Software packages[/size][/font]
Configuration limited to the environment and parameters
IQ verifies name and version
OQ tests user requirements

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Hi All,

Just wondering how you see this applying with the current version 5. I believe that firmware has been removed?
Thanks,
Mattossa

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Hi Mattossa,

This was actually a post from 8 years back before the release of GAMP 5.

Here is an article about the different categories that you may find useful.

http://www.askaboutvalidation.com/52497-process-control-systems-gamp-5-software-categories

Rgs