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http://www.spectroscopyonline.com/understanding-and-interpreting-new-gamp-5software-categories?id=&sk=&date=&%0A%09%09%09&pageID=3
http://computersystemsvalidation.blogspot.com/search/label/GAMP%205
The GAMP categories were originally introduced to provide an initial assessment as
to the validation requirements / deliverables.
GAMP: GOOD AUTOMATED MANUFACTURING PROCESS:
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.
Category 1: Greatly Expanded Scope Infrastructure Software
Category 1 has undergone a radical change and expansion from simply operating
systems, that had been constant in GAMP versions 1 to 4, to infrastructure software.
This category provides the computing environment for running both regulated and
nonregulated applications within an organization. It is broken down into two
subcategories:
a) Established or commercially available layered software: It includes
-Operating Systems
- databases
- programming languages
- middleware
- office software
- ladder logic interpreters (for manufacturing systems)
- statistical programming tools and spreadsheet packages.
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.
b) Infrastructure software tools:
Infrastructure software is a type of enterprise software or program specifically
designed to help business organizations perform basic tasks such as
workforce support, business transactions and internal services and processes.
Ex database programs, email and other communication software and security
applications.
Infrastructure software is also known as integration software or middleware.
Infrastructure software is used to ensure that people and systems within an
organization can connect and do their jobs properly and ensure the efficient
execution of business processes, share information, as well as manage touch points
with suppliers and customers. This type of software is not necessarily marketing
related or used for business transactions such as selling products and services, but
is more operations related, ensuring that business applications and processes can
keep running effectively.
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
The different types of application software are:
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.
Firmware was originally designed for high level software and could be changed
without having to exchange the hardware for a newer device. Firmware also retains
the basic instructions for hardware devices that make them operative. Without
firmware, a hardware device would be non-functional.
Techopedia explains Firmware
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.