GAMP 5 computer system categorization

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 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.

Category  details	Qualification requirement	Password control	Data Backup	Audit Trial Review	Software backup/ upgrade In case of malfunctioning
Category 1	YES	Not applicable	Not applicable	Not applicable	Not applicable
Category 2	Category Not Live in GAMP 5
Category 3A	YES	Not preferred	Not preferred	Not preferred	No, Change PLC/HMI
Category 3B	YES	Compulsory	Not preferred	Not preferred	No, Change PLC/HMI
Category 3C	YES	Compulsory	Compulsory	Compulsory	Preferred
Category 3D	YES	Compulsory	Compulsory	Compulsory	Preferred
Category 3E	YES	Compulsory	Compulsory	Compulsory	Preferred
Category 4	YES	Compulsory	Compulsory	Compulsory	Preferred
Category 5	YES	Compulsory	Compulsory	Compulsory	Preferred

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.