Software Classification Categories
Comparison of software categories in GAMP 4 and GAMP 5
As I mentioned earlier, the software categories in GAMP 5 have been revised. To appreciate the scope of these changes fully we need to look at the classification of software from GAMP 4 and compare this with GAMP 5.
In the beginning, or at least in GAMP 4, there were five categories of software:
Category 1: Operating systems
Category 2: Firmware
Category 3: Standard software
Category 4: Configured software
Category 5: Custom software
However, there was always a debate about some commercial software packages — were they category 3 or 4? Many spectroscopists would argue that an application should be classified as category 3 and not 4, as it should be less work to validate and evade the real classification. To help resolve this debate, in GAMP 5 the software categories have been revised and refined — most for the better and one for the worse. This is a natural evolution of this approach to software classification. So we now have the following four categories:
Category 1: Infrastructure Software
Category 3: Nonconfigured products
Category 4: Configured products
Category 5: Custom applications
Following explanations are provided for better clarity on each category with example.
Category 1 : Standard operating system. Ex. Windows XP
Category 2 : This category is not live in GAMP 5. (Its present in old version GAMP 4)
Category 3 : Non-configured products (standard applications)
Category 3 A : Where you can able view the reading. Ex. vernier calipers
Category 3 B : Where you can able view the reading and get system generated print. Ex.Analytical balance
Category 3 C : Where you can able view the reading, recipe can be selected and get system generated print. (No process data recoding and storage are available) Ex. Raw water generation system
Category 3 D : Where you can able view the reading, recipe can be selected , get system generated print and capable for store the data. Ex. Autoclave , Lyophilizer system , compression machine, BMS and EMS system,
Category 3 B : Where you can able view the reading and get system generated print. Ex.Analytical balance
Category 3 C : Where you can able view the reading, recipe can be selected and get system generated print. (No process data recoding and storage are available) Ex. Raw water generation system
Category 3 D : Where you can able view the reading, recipe can be selected , get system generated print and capable for store the data. Ex. Autoclave , Lyophilizer system , compression machine, BMS and EMS system,
Category 3 E : Where you can able view the reading, recipe can be selected , get system generated print and capable for store and process the data. Ex. QC equipment like IR, stand alone HPLC system
Category 4 :Configured software including, LIMS, SCADA, DCS, CDS, etc.Where you can able view the reading, recipe can be selected , get system generated print and capable for store and process and configure the data based on your requirement.
Category 5 : Bespoke software /Custom applications – Ex. Design Electronic batch record.
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Category details
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Qualification requirement
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Password control
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Data Backup
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Audit Trial Review
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Software backup/ upgrade In case of malfunctioning
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Category 1
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YES
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Not applicable
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Not applicable
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Not applicable
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Not applicable
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Category 2
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Category Not Live in GAMP 5
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Category 3A
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YES
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Not preferred
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Not preferred
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Not preferred
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No, Change PLC/HMI
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Category 3B
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YES
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Compulsory
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Not preferred
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Not preferred
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No, Change PLC/HMI
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Category 3C
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YES
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Compulsory
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Compulsory
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Compulsory
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Preferred
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Category 3D
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YES
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Compulsory
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Compulsory
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Compulsory
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Preferred
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Category 3E
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YES
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Compulsory
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Compulsory
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Compulsory
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Preferred
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Category 4
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YES
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Compulsory
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Compulsory
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Compulsory
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Preferred
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Category 5
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YES
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Compulsory
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Compulsory
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Compulsory
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Preferred
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If system is 3C level then don’t change its category by putting data storage capability and audit trial review , but consider you have below mention controls,
- Access level control is available with dedicated system ID’s and password.
- Process CPP is printed in hard format.
- Event & Alaram log is printed in hard format.
- Final hard data is signed by done and checked by and attached with batch record or filed separately
- Hard copy are preserved as per approved retention period
Then audit trial review and data backup can be ignored. Remember automation having certain advantages and certain disadvantages too.
great article!
great article!
Indeed a great article ! Can i get the document where it is mentioned.
Indeed a great article ! Can i get the document where it is mentioned.
Indeed a great article ! Can i get the document where it is mentioned.
That is the question that only my husband can explain the things that I don't undertand.
That is the question that only my husband can explain the things that I don't undertand.
That is the question that only my husband can explain the things that I don't undertand.
After reading your article, I realized that you did a lot of research before writing this post.
After reading your article, I realized that you did a lot of research before writing this post.