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The GAMP (Good Automated Manufacturing Practice) guide version 5 was released
in March 2008 amd Version 1 was released in 1994.
GAMP classification addresses a built-in risk assessment. The least risky and most
widely available software is in category 1 (operating systems, databases, office
software, and other widely available software). This is widely available software that
can be used by anyone and in any industry. As we progress through down the
categories , generally the software becomes more specialized in its function (from a
general office application to software that can control a spectrometer to acquire and
process data then report the results). As we go down the list there is the increasing
ability of the users to change the operation of software and process the results . In
category 5 is a unique solution that is conceived, specified, written, tested, and
maintained by the users or the organization; here is the greatest risk.
-Operating Systems
- databases
- programming languages
- middleware
- office software
The key issue is that many of these software tools are the base products for the
applications used in the laboratory or they are the foundation layer for the
laboratory applications to operate under.
These programs are divided into two classes: system software and application
software. While system software consists of low-level programs that interact with
computers at a basic level, application software resides above system software and
includes database programs, word processors, spreadsheets, etc
Content Access Software: Used to access contents and addresses a desire for
published digital content and entertainment.
Note that category 1 also includes office software such as word processing,
spreadsheet, database, and presentation applications. Now before you rush off
thinking that Excel templates and macros do not need to be validated, think again,
as the guide notes that "applications developed using these packages" are excluded
from category 1 and these can be category 3, 4, or 5, respectively (1), depending on
their complexity.
In GAMP 4 there were five software categories. These have been revised in GAMP5
to four categories as detailed below:
Category 2: Firmware
Low Level Firmware: This is found in ROM, OTP/PROM and PLA structures. Low level
firmware is often read-only memory and cannot be changed or updated. It is
sometimes referred to as hardware.
High Level Firmware: This is used in flash memory for updates that is often
considered as software.
Subsystems: These have their own fixed microcode embedded in flash chips, CPUs
and LCD units. A subsystem is usually considered part of the hardware device as
well as high level firmware.
BIOS, modems and video cards are usually easy to update. But firmware in storage
devices usually gets overlooked; there are no standardized systems for updating
firmware. Fortunately, storage devices do not need to be updated often.
Category 3 – Non configurable software including, commercial off the shelf software
(COTS), Laboratory Instruments / Software.
Category 2 from GAMP 4 has been removed. This 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 recognised that complex
software can be embedded (firmware) within systems.
software that is used as installed falls into category 3 and may also
include software that is configurable (category 4) but is used either
unconfigured or with the standard defaults provided by the software
supplier.=>=> category 3 software is also configured, but for the
environment (run-time configuration).
RUN TIME CONFIGURATION:
a) Upon installation of category 3 application, the software is capable of
operating and automating the business process without any
modification and it cannot be changed in this respect. This type of
application is also called canned software or commercial-off-the-shelf
software (COTS), or even off-the-shelf software (OTS).
b) Defines items in the software to enable the system to operate within
the installed environment. Ex: users and user types for authorized
individuals, entry of the department or company name into report
headers, selection of units to present or report data, default data
storage location (either a local or network directory), and the default
printer.
Thus the key characteristic of software in this category is that run
time configuration does not change the automation of the business
process or the collection and analysis of the data and records
generated by the software.( This is in contrast with category 4
software, in which the actual operation of the software to support the
business process is changed to match the laboratory business
process.)
HITESH NOTES:
GAMP 1 Infrastructure Software: Does the system fall under established or
commercially available layered software or Infrastructure software tools?
applications are developed to run under the control of established or
commercially available layered software. This includes operating system,
database managers, programming languages, statistical programming
tools and spreadsheet packages and/or also including tools as network
monitoring software, batch job scheduling tools, security software, anti-
virus and configuration management tools.
GAMP3-– Non Configured Products: Is this a commercially available
standard software package providing an off the shelf solution to a
business or manufacturing process?
a system that cannot be configured to conform to business processes and
systems that are configurable but only default configuration is used. Ex:
Firmware applications, COTS instruments, etc.,)
GAMP Category 4 – Configured Products : system software can be
configured to meet the specific needs of the business process. This
involves configuring predefined software modules, but software code
cannot be altered. Ex: LIMS, SCADA, ERP, DCS, etc.
Is the System or Application a configurable software product that provides
a standard interface and functions that enable configuration of user
specific business process?
GAMP Category 5 – Custom Applications
Is the System or Application custom developed software, or a custom
extension to an existing system?
the system or application is a custom developed software, or a custom
extension to an existing system. These are complex systems that often
have layers of software with one system including components of several
software categories. Ex: Custom DCS module blocks, Custom
programming language, Spreadsheet with custom macro etc