Just struck with a question today. Is GAMP5 CATEGORISATION different for software and hardware?If yes what are the categories for GAMP5 for hardware?

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Posted by Anonymous (Discussions: 1, Comments: 2)
Replied on May 16, 2017 12:00 am
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For H/W its cat 1 and cat 2. Pls refer GAMP IT Infrastructure Qualification
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Posted by Rishu Ranjan (Discussions: 0, Comments: 1)
Replied on May 15, 2017 8:00 pm
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From GAMP4 to GAMP5, there is some consolidation in this area. GAMP5 lists two categories for HW (Cat 1 - Standard Cat2 - Custom-built). In addition, GAMP5 software categories 1 and 3 may apply to components that operate hardware (e.g.: firmware is Software Cat 3). References: GAMP5, Appendix M4 and GAMP Good Practice guide on IT Infrasture Control and Compliance.
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Posted by Duraisamy Rajan Palani (Discussions: 1, Comments: 15)
Replied on May 15, 2017 8:00 pm
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The above is not correct, and was never a correct definition. The GAMP 5 (2008) standard has the following categories.
Category 1: Infrastructure Software
Category 3: Non-configured products
Category 4: Configured products
Category 5: Custom applications
GAMP applied/applies to S/W. An older version had a definition for Category 1 - operating systems, but it referred to S/W residing on operating systems, not the H/W itself. Same for the former definition of Category 2.
GAMP 5 - 2008 is readily available, worldwide.
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Posted by George Butcher (Discussions: 0, Comments: 195)
Replied on May 15, 2017 8:00 pm
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G M Butcher - Which part of the above explanation is incorrect? What you have listed is for software (and everyone here is reasonably familiar with it, I reckon). The question is about hardware categorization and there is a reference to the same in GAMP5 (Refer to the Appendix M4 of GAMP 5 on Page 132). Trust this clarifies.
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Posted by Duraisamy Rajan Palani (Discussions: 1, Comments: 15)
Replied on May 15, 2017 8:00 pm
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Thank you everyone for the clarification
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Posted by Anonymous (Discussions: 1, Comments: 2)
Replied on May 15, 2017 8:00 pm
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Cat 1 ... standard hardware can be used with multiple things
Cat 2 customize hardware used for specific purpose
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Posted by Vikas Parmar (Discussions: 0, Comments: 1)
Replied on May 16, 2017 8:00 pm
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Thanks vikas
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Posted by Anonymous (Discussions: 1, Comments: 2)
Replied on May 16, 2017 8:00 pm
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It is true that GAMP 5 2008 talked about HW Category 1 and 2 out of which 99% you will get to see Cat -1 - Standard. The soon to be published GAMP GPG on IT Infra and Control talks about Platforms, Processes and Personnel and platforms provide a well-defined foundation for other well-defined HW or SW components. Platform Qualification Plan separates the qualification of platforms from the validation of GxP applications i.e. adding or changing an application will not affect the qualified status of the platform (unless platform is impacted due to the changes).
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Posted by Arjun Guha Thakurta (Discussions: 0, Comments: 26)
Replied on May 16, 2017 8:00 pm
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This is good piece of information. Where can I read up more about it?
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Posted by Anonymous (Discussions: 1, Comments: 2)
Replied on May 16, 2017 8:00 pm
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GAMP Good Practice Guide on IT Infrastructure Controls and Compliance.. and its already published. You can buy it from the ISPE online store. I am happy to share an extract that doesn't violate the copyright. Please send me your email id.
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Posted by Duraisamy Rajan Palani (Discussions: 1, Comments: 15)
Replied on May 16, 2017 8:00 pm
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