Change Control
Encyclopedia
Change control within Quality management system
s (QMS) and Information Technology
(IT) systems is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. It reduces the possibility that unnecessary changes will be introduced to a system without forethought, introducing faults into the system or undoing changes made by other users of software. The goals of a change control procedure usually include minimal disruption to services, reduction in back-out activities, and cost-effective utilization of resources involved in implementing change.
Change control is currently used in a wide variety of products and systems. For Information Technology
(IT) systems it is a major aspect of the broader discipline of change management
. Typical examples from the computer
and network
environments are patches to software products, installation of new operating system
s, upgrades to network routing
tables, or changes to the electrical power
systems supporting such infrastructure
.
Certain portions of the Information Technology Infrastructure Library
cover change control.
, configuration management
and change control. The definition below is not yet integrated with definitions of the others.
Certain experts describe change control as a set of six steps:
regulated industry, the topic is frequently encountered by its users. Various industrial guidances and commentaries are available for people to comprehend this concept. As a common practice, the activity is usually directed by one or more SOPs. From the information technology
perspective for clinical trial
s, it has been guided by another USFDA document.
Quality management system
A quality management system can be expressed as the organizational structure, procedures, processes and resources needed to implement quality management.-Elements of a Quality Management System:# Organizational structure# Responsibilities# Methods...
s (QMS) and Information Technology
Information technology
Information technology is the acquisition, processing, storage and dissemination of vocal, pictorial, textual and numerical information by a microelectronics-based combination of computing and telecommunications...
(IT) systems is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. It reduces the possibility that unnecessary changes will be introduced to a system without forethought, introducing faults into the system or undoing changes made by other users of software. The goals of a change control procedure usually include minimal disruption to services, reduction in back-out activities, and cost-effective utilization of resources involved in implementing change.
Change control is currently used in a wide variety of products and systems. For Information Technology
Information technology
Information technology is the acquisition, processing, storage and dissemination of vocal, pictorial, textual and numerical information by a microelectronics-based combination of computing and telecommunications...
(IT) systems it is a major aspect of the broader discipline of change management
Change Management (ITSM)
Change management is an IT service management discipline. The objective of change management in this context is to ensure that standardized methods and procedures are used for efficient and prompt handling of all changes to control IT infrastructure, in order to minimize the number and impact of...
. Typical examples from the computer
Computer
A computer is a programmable machine designed to sequentially and automatically carry out a sequence of arithmetic or logical operations. The particular sequence of operations can be changed readily, allowing the computer to solve more than one kind of problem...
and network
Computer network
A computer network, often simply referred to as a network, is a collection of hardware components and computers interconnected by communication channels that allow sharing of resources and information....
environments are patches to software products, installation of new operating system
Operating system
An operating system is a set of programs that manage computer hardware resources and provide common services for application software. The operating system is the most important type of system software in a computer system...
s, upgrades to network routing
Routing
Routing is the process of selecting paths in a network along which to send network traffic. Routing is performed for many kinds of networks, including the telephone network , electronic data networks , and transportation networks...
tables, or changes to the electrical power
Electric power
Electric power is the rate at which electric energy is transferred by an electric circuit. The SI unit of power is the watt.-Circuits:Electric power, like mechanical power, is represented by the letter P in electrical equations...
systems supporting such infrastructure
Infrastructure
Infrastructure is basic physical and organizational structures needed for the operation of a society or enterprise, or the services and facilities necessary for an economy to function...
.
Certain portions of the Information Technology Infrastructure Library
Itil
Itil may mean:*Atil or Itil, the ancient capital of Khazaria*Itil , also Idel, Atil, Atal, the ancient and modern Turkic name of the river Volga.ITIL can stand for:*Information Technology Infrastructure Library...
cover change control.
The process
There is considerable overlap and confusion between change managementChange management
Change management is a structured approach to shifting/transitioning individuals, teams, and organizations from a current state to a desired future state. It is an organizational process aimed at helping employees to accept and embrace changes in their current business environment....
, configuration management
Configuration management
Configuration management is a field of management that focuses on establishing and maintaining consistency of a system or product's performance and its functional and physical attributes with its requirements, design, and operational information throughout its life.For information assurance, CM...
and change control. The definition below is not yet integrated with definitions of the others.
Certain experts describe change control as a set of six steps:
- Record / Classify
- Assess
- Plan
- Build / Test
- Implement
- Close / Gain Acceptance
Record/classify
The client initiates change by making a formal request for something to be changed. The change control team then records and categorizes that request. This categorization would include estimates of importance, impact, and complexity.Assess
The impact assessor or assessors then make their risk analysis typically by answering a set of questions concerning risk, both to the business and to the process, and follow this by making a judgment on who should carry out the change. If the change requires more than one type of assessment, the head of the change control team will consolidate these. Everyone with a stake in the change then must meet to determine whether there is a business or technical justification for the change. The change is then sent to the delivery team for planning.Plan
Management will assign the change to a specific delivery team, usually one with the specific role of carrying out this particular type of change. The team's first job is to plan the change in detail as well as construct a regression plan in case the change needs to be backed out.Build/test
If all stakeholders agree with the plan, the delivery team will build the solution, which will then be tested. They will then seek approval and request a time and date to carry out the implementation phase.Implement
All stakeholders must agree to a time, date and cost of implementation. Following implementation, it is usual to carry out a post-implementation review which would take place at another stakeholder meeting.Close/gain acceptance
When the client agrees that the change was implemented correctly, the change can be closed.Regulatory environment
In a Good Manufacturing PracticeGood Manufacturing Practice
"Good manufacturing practice" or "GMP" are practices and the systems required to be adapted in pharmaceutical manufacturing, quality control, quality system covering the manufacture and testing of pharmaceuticals or drugs including active pharmaceutical ingredients, diagnostics, foods,...
regulated industry, the topic is frequently encountered by its users. Various industrial guidances and commentaries are available for people to comprehend this concept. As a common practice, the activity is usually directed by one or more SOPs. From the information technology
Information technology
Information technology is the acquisition, processing, storage and dissemination of vocal, pictorial, textual and numerical information by a microelectronics-based combination of computing and telecommunications...
perspective for clinical trial
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
s, it has been guided by another USFDA document.
See also
- DocumentationDocumentationDocumentation is a term used in several different ways. Generally, documentation refers to the process of providing evidence.Modules of Documentation are Helpful...
- IdentifierIdentifierAn identifier is a name that identifies either a unique object or a unique class of objects, where the "object" or class may be an idea, physical [countable] object , or physical [noncountable] substance...
- Revision controlRevision controlRevision control, also known as version control and source control , is the management of changes to documents, programs, and other information stored as computer files. It is most commonly used in software development, where a team of people may change the same files...
- Living DocumentLiving documentA living document or dynamic document is a document which may be continually edited and updated by either a limited or unrestricted group. A simple example of a living document is an article in Wikipedia, in contrast to "dead" or "static" documents, such as an article in a single edition of the...
- Specification (technical standard)Specification (technical standard)A specification is an explicit set of requirements to be satisfied by a material, product, or service. Should a material, product or service fail to meet one or more of the applicable specifications, it may be referred to as being out of specification;the abbreviation OOS may also be used...
- StandardizationStandardizationStandardization is the process of developing and implementing technical standards.The goals of standardization can be to help with independence of single suppliers , compatibility, interoperability, safety, repeatability, or quality....