149:, steering committee, or project manager, a review and approval process is typically required. The plan/scope and impact/risk assessments are considered in the context of business goals, requirements, and resources. If, for example, the change request is deemed to address a low severity, low impact issue that requires significant resources to correct, the request may be made low priority or shelved altogether. In cases where a high-impact change is requested but without a strong plan, the review/approval entity may request a full
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proposed change: high-, moderate-, or low-risk. High-risk change requires many additional steps such as management approval and stakeholder notification, whereas low-risk change may only require project manager approval and minimal documentation. If not addressed in the plan/scope, the desire for a backout plan should be expressed, particularly for high-risk changes that have significant worst-case scenarios.
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quality management standards. The implementation process may also require additional staff responsibilities outside the implementation team, including stakeholders who may be asked to assist with troubleshooting. Following implementation, the team may also carry out a post-implementation review, which would take place at another stakeholder meeting or during project closing procedures.
170:. Little in the way of testing and validation may occur for low-risk changes, though major changes will require significant testing before implementation. They will then seek approval and request a time and date to carry out the implementation phase. In rare cases where the solution can't be tested, special consideration should be made towards the change/implementation window.
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The closing process can be one of the more difficult and important phases of change control. Three primary tasks at this end phase include determining that the project is actually complete, evaluating "the project plan in the context of project completion," and providing tangible proof of project
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In most cases a special implementation team with the technical expertise to quickly move a change along is used to implement the change. The team should also be implementing the change not only according to the approved plan but also according to organizational standards, industry standards, and
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Consider the primary and ancillary detail of the proposed change. This should include aspects such as identifying the change, its owner(s), how it will be communicated and executed, how success will be verified, the change's estimate of importance, its added value, its conformity to business and
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Impact and risk assessment is the next vital step. When executed, will the proposed plan cause something to go wrong? Will related systems be impacted by the proposed change? Even minor details should be considered during this phase. Afterwards, a risk category should ideally be assigned to the
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Change control is used in various industries, including in IT, software development, the pharmaceutical industry, the medical device industry, and other engineering/manufacturing industries. For the IT and software industries, change control is a major aspect of the broader discipline of change
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is a process—either formal or informal—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
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If the change control request is approved to move forward, the delivery team will execute the solution through a small-scale development process in test or development environments. This allows the delivery team an opportunity to design and make incremental changes, with
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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. According to the
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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
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success. If despite best efforts something went wrong during the change control process, a post-mortem on what happened will need to be run, with the intent of applying lessons learned to future changes.
45:, change control is a "process whereby modifications to documents, deliverables, or baselines associated with the project are identified, documented, approved, or rejected."
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and change control. The definition below is not yet integrated with definitions of the others.
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Managing the
Software Enterprise: Software Engineering and Information Systems in Context
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Scheduling and Cost Control: Planning, Monitoring and Controlling the Baseline
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Scheduling and Cost Control: Planning, Monitoring and Controlling the Baseline
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719:"Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients"
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Implementing
Information Security in Healthcare: Building a Security Program
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765:"Guidance for Industry - COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS"
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798:. Project Management Institute (7th ed.). Newtown Square, PA.
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environments are patches to software products, installation of new
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Process ensuring that changes to a product or system are controlled
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industry standards, and its target date for completion.
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Change control can be described as a set of six steps:
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374:"10 essential elements of change control management"
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818:: CS1 maint: location missing publisher (
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403:Pharmaceutical Engineering Change Control
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632:. J. Ross Publishing. pp. 215–225.
547:. J. Ross Publishing. pp. 192–203.
436:(2nd ed.). CRC Press. p. 205.
580:Operational Excellence Program Office.
153:may be requested for further analysis.
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313:. Cengage Learning. pp. 318–325.
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213:, it has been guided by another U.S.
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307:Hall, P.A.V.; Ramil, J.C.F. (2007).
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267:Specification (technical standard)
145:Whether it's a change controller,
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837:Information technology management
769:U.S. Food and Drug Administration
668:U.S. Food and Drug Administration
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516:Project Management Institute 2021
407:. Taylor & Francis. pp.
399:Turner, S.G. (15 December 2003).
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461:. CRC Press. p. 280.
343:, Glossary §3 Definitions.
65:tables, or changes to the
28:quality management systems
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742:GMP Online Consultancy.
582:"Change Control Process"
237:Engineering change order
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94:configuration management
69:systems supporting such
19:Not to be confused with
432:Teixeira, M.B. (2013).
380:. CBS Interactive, Inc
207:information technology
192:Regulatory environment
80:cover change control.
61:, upgrades to network
32:information technology
457:Monahanm E. (1995).
147:change control board
76:Certain portions of
624:Taylor, J. (2008).
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183:Close
118:Close
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800:ISBN
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Text is available under the Creative Commons Attribution-ShareAlike License. Additional terms may apply.