Gamp 5 Software Categories

Gamp 5 Software Categories Average ratng: 4,6/5 1773 votes

However, functional and configuration specifications are not required when using commercial off-the-shelf software Category 3. Good practice guides are also available for just about every type of GxP computerized system, such as GxP process control systems, GxP systems used to apply electronic signatures and GxP laboratory systems. As discussed in ISPE GAMP 5 the GAMP Categories for hardware and software have been retained in GAMP 5, all be it in a modified format from GAMP4. The software categories identified in GAMP 5 do not fit with determining the risk to product quality, efficacy or data integrity and no longer plays an integral part to determining that a computer system is fit for purpose. Concept of GAMP 5 in Pharmaceuticals GAMP 5 should be implemented for the automated systems in pharmaceutical manufacturing and quality control to produce the high quality products. Good Automated Manufacturing Practice (GAMP) is a recognised code of practice in pharmaceutical industry; however, it is not legally binding. Popular Categories.

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Software categories are groups of software. They allow software to be understood in terms of those categories. Instead of the particularities of each package. Different classification schemes consider different aspects of software.

1Computer Software
- 1.1Copyright status
2Microsoft TechNet and AIS Software categories

Computer Software[edit]

Computer software can be put into categories based on common function, type, or field of use. There are three broad classifications:

Application software is the general designation of computer programs for performing tasks. Application software may be general purpose (word processing, web browsers, etc.) or have a specific purpose (accounting, truck scheduling, etc.). Application software contrasts with system software.
System software is a generic term referring to the computer programs used to start and run computer systems including diverse application software and networks.
Computer programming tools, such as compilers and linker, are used to translate and combine computer program source code and libraries into executable RAMs (programs that will belong to one of the three said)

Copyright status[edit]

The GNU Project categorizes software by copyright status: free software, open source software, public domain software, copylefted software, noncopylefted free software, lax permissive licensed software, GPL-covered software, the GNU operating system, GNU programs, GNU software, FSF-copyrighted GNU software, nonfree software, proprietary software, freeware, shareware, private software and commercial software.^[1]

Free software[edit]

Free software is software that comes with permission for anyone to use, copy and distribute, either verbatim or with modifications, either gratis or for a fee. In particular, this means that source code must be available. 'If it's not source, it's not software.' If a program is free, then it can potentially be included in a free operating system such as GNU, or free versions of the Linux system.

Free software in the sense of copyright license (and the GNU project) is a matter of freedom, not price. But proprietary software companies typically use the term 'free software' to refer to price. Sometimes this means a binary copy can be obtained at no charge; sometimes this means a copy is bundled with a computer for sale at no additional charge.^[1]

Open source software[edit]

Adobe reader 11 download softonic. Open source software is software with its source code made available under a certain license to its licensees. It can be used and disseminated at any point, the source code is open and can be modified as required. The one condition with this type of software is that when changes are made users should make these changes known to others. One of the key characteristics of open source software is that it is the shared intellectual property of all developers and users. The Linux operating system is one of the best known examples of a collection of open source software.^[2]

Copylefted software[edit]

Copylefted software is free software whose distribution terms ensure that all copies of all versions carry more or less the same distribution terms. This means, for instance, that copyleft licenses generally disallow others to add additional requirements to the software (though a limited set of safe added requirements can be allowed) and require making source code available. This shields the program, and its modified versions, from some of the common ways of making a program proprietary. Some copyleft licenses block other means of turning software proprietary.

Copyleft is a general concept. Copylefting an actual program requires a specific set of distribution terms. Different copyleft licenses are usually “incompatible” due to varying terms, which makes it illegal to merge the code using one license with the code using the other license. If two pieces of software use the same license, they are generally mergeable.^[1]

Non-copylefted free software[edit]

Noncopylefted free software comes from the author with permission to redistribute and modify and to add license restrictions.

If a program is free but not copylefted, then some copies or modified versions may not be free. A software company can compile the program, with or without modifications, and distribute the executable file as a proprietary software product. The X Window System illustrates this approach. The X Consortium releases X11 with distribution terms that make it noncopylefted free software. If you wish, you can get a copy which has those distribution terms and is free. However, nonfree versions are available and workstations and PC graphics boards for which nonfree versions are the only ones that work. The developers of X11 made X11 nonfree for a while; they were able to do this because others had contributed their code under the same noncopyleft license.^[1]

Shareware[edit]

Shareware is software that comes with permission to redistribute copies, but says that anyone who continues to use a copy is required to pay. Shareware is not free software, or even semi-free. For most shareware, source code is not available; thus, the program cannot be modified. Shareware does not come with permission to make a copy and install it without paying a license fee, including for nonprofit activity.^[1]

Freeware[edit]

Like shareware, freeware is software available for download and distribution without any initial payment. Freeware never has an associated fee. Things like minor program updates and small games are commonly distributed as freeware. Though freeware is cost free, it is copyrighted, so other people can't market the software as their own.^[3]

Microsoft TechNet and AIS Software categories[edit]

This classification has seven major elements. They are: platform and management, education and reference, home and entertainment, content and communication, operations and professional, product manufacturing and service delivery, and line of business.

Platform and management—Desktop and network infrastructure and management software that allows users to control the computer operating environment, hardware components and peripherals and infrastructure services and security.^[4]
Education and reference—Educational software that does not contain resources, such as training or help files for a specific application.^[4]
Home and entertainment—Applications designed primarily for use in or for the home, or for entertainment.^[4]
Content and communications—Common applications for productivity, content creation, and communications. These typically include office productivity suites, multimedia players, file viewers, Web browsers, and collaboration tools.^[4]
Operations and professional—Applications designed for business uses such as enterprise resource management, customer relations management, supply chain and manufacturing tasks, application development, information management and access, and tasks performed by both business and technical equipment.^[4]
Product manufacturing and service delivery—Help users create products or deliver services in specific industries. Categories in this section are used by the North American Industry Classification System (NAICS).

Vertical applications[edit]

Agriculture, Forestry and Hunting
Mining, Quarrying, and Oil and Gas Extraction
Manufacturing
Transportation and Warehousing
Finance and Insurance
Real Estate and Rental and Leasing

Professional, Scientific,

Postal and Mailing
Management of Companies and Enterprises
Administrative and Support and Waste Management and Remediation Services
Health Care and Social Assistance
Arts, Entertainment, and Recreation
Accommodation and Food Services
Other Services (except Public Administration)^[4]
Internal and proprietary line-of-business applications^[4]

References[edit]

^ ^a^b^c^d^e'Categories of Free and Nonfree Software - GNU Project - Free Software Foundation (FSF)'. Gnu.org. 2012-10-18. Retrieved 2012-11-12.
^'Heidelberg - Glossary - O'. Directimaging.com. Retrieved 2012-11-12.
^'Freeware Definition'. Techterms.com. Retrieved 2012-11-12.
^ ^a^b^c^d^e^f^g'This Topic Is No Longer Available'. Technet.microsoft.com. Archived from the original on 2008-09-21. Retrieved 2012-11-12.

External links[edit]

Wikiversity has learning resources about Computer Software

Retrieved from 'https://en.wikipedia.org/w/index.php?title=Software_categories&oldid=917694682'

What is GAMP 5?

Good Automated Manufacturing Practice, Founded in 1991. International Society for Pharmaceutical Engineering (ISPE) sets the guidelines for manufacturers and the current Version is GAMP 5.
GAMP describes a set of principles and procedures that help ensure that pharmaceutical Software have required quality.
Computer system validation (CSV) following GAMP guidelines require users and suppliers to work together so that responsibilities regarding the validation process are understood.
For users: GAMP provides a documented assurance that a system is appropriate for the intended use before it goes “live.”
Suppliers can use GAMP to test for avoidable defects in the supplied system to ensure quality products are produced.

Why GAMP 5?

Facilitates the interpretation of regulatory requirements.
Establishes a common language and terminology.
Promotes a system life cycle approach based on good practice.
Clarifies roles and responsibilities.
Focus attention on those computerised systems with most impact on patient safety, product quality, and data integrity
Avoid duplication of activities

GAMP 5 Categories

Difference between Category 4 and Category 5 in GAMP 5

Configuration and customisation of software are terms that are poorly defined in the validation world and frequently used interchangeably, especially in a vendor's marketing literature.
It is important to understand the difference between these two terms as they mean entirely different things and consequently can have a dramatic impact on the amount of validation work that you could undertake.

Configuration: The modification of the function of a software product to meet business process or user requirements using tools supplied by the supplier. These tools can include input of user-defined text strings for drop-down menus, turning software functions on or off, graphical dragging and dropping of information elements, and creation of specific reports using the standard functionality of the package.

Customisation: The writing of software modules, scripts, procedures, or applications to meet business requirements. This can be achieved using an external programming language (such as C++ or .NET or PL*SQL for database procedures), macro instructions, or an internal scripting language specific for a commercial application.

Depending on the user requirements the same implementation can be Category 4 or 5

What is SDLC Model? and What model GAMP 5 Suggests?

•The software development life cycle (SDLC) is a framework defining tasks performed at each step in the software development process.

SDLC is a structure followed by a development team within the software organization.
IIt consists of a detailed plan describing how to develop, maintain and replace specific software.
The life cycle defines a methodology to deliver the quality of software and the overall development process.

What is 21 CFR Part 11 and EU Annex 11?

21 CFR (Code of Federal Regulations) Part 11 has defined by the US FDA regulations that set forth the criteria applies to electronic records and electronic signatures that persons create, modify, maintain, archive, retrieve, or transmit under any records or signature requirement set forth in the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, or any FDA regulation
Annex 11 is part of the European GMP Guidelines and defines the terms of reference for computerised systems used by organisations in the pharmaceutical industry.

Gamp 5 Categories Table

Queries?

Any relation between GAMP 5 or v Model with 21 CFR Part 11 ?

Both are the set of guidelines which are used to validate a computer based software used in a pharma manufacturing companies.
The guidelines are predefined and a software should comply with the guidelines.
GAMP talks about “the How” and the 21 CFR talks “the What” during the Validation of computer based software for Pharma companies.
GAMP is a methodology and 21 CFR is a regulation.
21 CFR Part 11 is US FDA and Annex 11 is EU guidelines.

2. A Company is delivering a software to banking sector they never heard of part 11 but when the Pharma customer wants them to map Part 11 requirements will the solution comply with them?