Gamp Classification 6e66

GAMP Categories 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 s 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 s 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 , 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:

Application Suite: Has multiple applications bundled together. Related functions, features and interfaces interact with each other. Enterprise Software: Addresses an organization's needs and data flow in a huge distributed environment. Enterprise Infrastructure Software: Provides capabilities required to enterprise software systems. Information Worker Software: Addresses individual needs required to manage and create information for individual projects within departments. Content Access Software: Used to access contents and addresses a desire for published digital content and entertainment. Educational Software: Holds contents adopted for use by students. Media Development Software: Addresses individual needs to generate and print electronic media for others to consume.

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.

Note also the phrasing of the subcategory "established or commercially In GAMP 4 there were five software categories. These have been revised in GAMP5 to four categories as detailed below: Category 1 – Infrastructure software including operating systems, Database Managers, etc. Category 2: Firmware Firmware is a software program permanently etched into a hardware device such as a keyboards, hard drive, BIOS, or video cards. It is programmed to give permanent instructions to communicate with other devices and perform functions like basic input/output tasks. Firmware is typically stored in the flash ROM (read only memory) of a hardware device. It can be erased and rewritten.

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

Originally, firmware had read-only memory (ROM) and programmable read-only memory (PROM). It was designed to be permanent. Eventually PROM chips could be updated and were called erasable programmable read-only memory (EPROM). But EPROM was expensive, time consuming to update and challenging to use. Firmware eventually evolved from ROM to flash memory firmware; thus, it became easier to update and friendly.

There are levels of 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, Us 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 4 – Configured software including, LIMS, SCADA, DCS, CDS, etc.

Category 5 – Bespoke 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.

CATEGORY 3: renamed from standard software ( GAMP4) to NONCONFIGURED SOFTWARE (GAMP5)  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: s and 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 the business process is changed to match the laboratory business process.)

THEREFORE THE SAME SOFTWARE CAN FALL INTO CATEGORY 3 OR CATEGORY 4 = depending on whether the default settings are used ( III) or if the application is configured (IV). CATEGORY 4: CONFIGURED Products he major difference between category 3 and 4 software, as mentioned earlier, is the ability to modify the function of the software to match a business process. The has the means and knowledge to change the functionality of the device in a way that changes the results outputted by the device. As a direct consequence, this triggers increased validation effort. There are many ways to achieve this but the essence is to take standard software modules that provide the basic functionality to automate a process and change it by configuration tools. These tools are provided by the vendor of the

product, hence configuration rather than using an external language to write custom code that is attached to the product. However, these tools can vary in their nature from simple configuration buttons that turn a feature on or off to graphical drag-and-drop to a modular "configuration" language that typically writes large blocks of software; hence, custom code, which raises the debate of configuration versus customization. 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, antivirus 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 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