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
137:
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.
179:
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.
714:
187:
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
178:
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
127:
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
136:
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
48:
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
38:
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
161:
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
39:
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
200:
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
764:
188:
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."
819:
768:
667:
836:
743:
803:
846:
718:
660:
266:
637:
552:
493:
466:
441:
416:
318:
373:
214:
202:
40:
841:
197:
276:
27:
690:
236:
93:
581:
206:
31:
604:
602:
146:
813:
167:
96:
and change control. The definition below is not yet integrated with definitions of the others.
799:
633:
625:
548:
542:
489:
483:
462:
437:
412:
408:
401:
314:
308:
89:
58:
54:
271:
261:
251:
20:
310:
Managing the
Software Enterprise: Software Engineering and Information Systems in Context
226:
210:
70:
66:
630:
Project
Scheduling and Cost Control: Planning, Monitoring and Controlling the Baseline
544:
Project
Scheduling and Cost Control: Planning, Monitoring and Controlling the Baseline
830:
241:
150:
661:"Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations"
231:
163:
246:
719:"Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients"
485:
Implementing
Information Security in Healthcare: Building a Security Program
256:
488:. Healthcare Information and Management Systems Society. pp. 204–205.
50:
62:
765:"Guidance for Industry - COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS"
798:. Project Management Institute (7th ed.). Newtown Square, PA.
57:
environments are patches to software products, installation of new
16:
Process ensuring that changes to a product or system are controlled
796:
A guide to the project management body of knowledge (PMBOK guide)
77:
608:
515:
459:
340:
128:
industry standards, and its target date for completion.
99:
Change control can be described as a set of six steps:
691:"Challenges of Change Control in a Regulated Industry"
744:"Change control system: Standard Operating Procedure"
619:
617:
374:"10 essential elements of change control management"
88:
There is considerable overlap and confusion between
367:
365:
363:
361:
359:
357:
355:
353:
351:
349:
400:
575:
573:
571:
536:
534:
532:
530:
528:
526:
524:
482:Herzig, T.W.; Walsh, T.; Gallagher, L.A. (2013).
302:
300:
298:
296:
294:
292:
434:Design Controls for the Medical Device Industry
626:"Chapter 11: Successfully Closing the Project"
8:
818:: CS1 maint: location missing publisher (
403:Pharmaceutical Engineering Change Control
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.
288:
153:may be requested for further analysis.
811:
313:. Cengage Learning. pp. 318–325.
49:management. Typical examples from the
794:Project Management Institute (2021).
213:, it has been guided by another U.S.
7:
307:Hall, P.A.V.; Ramil, J.C.F. (2007).
587:. University of California Berkeley
267:Specification (technical standard)
145:Whether it's a change controller,
14:
837:Information technology management
769:U.S. Food and Drug Administration
668:U.S. Food and Drug Administration
609:Project Management Institute 2021
516:Project Management Institute 2021
407:. Taylor & Francis. pp.
399:Turner, S.G. (15 December 2003).
341:Project Management Institute 2021
1:
611:, §4.4.3 Meetings and Events.
518:, §4.6.3 Meetings and Events.
372:Matteson, S. (7 July 2017).
215:Food and Drug Administration
42:Project Management Institute
847:Software project management
198:good manufacturing practice
863:
461:. CRC Press. p. 280.
343:, Glossary §3 Definitions.
65:tables, or changes to the
28:quality management systems
18:
742:GMP Online Consultancy.
582:"Change Control Process"
237:Engineering change order
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).
541:Taylor, J. (2008).
842:Project management
168:regression testing
805:978-1-62825-664-2
141:Review / approval
109:Review / approval
90:change management
59:operating systems
854:
823:
817:
809:
781:
780:
778:
776:
761:
755:
754:
752:
750:
739:
733:
732:
730:
728:
723:
711:
705:
704:
702:
700:
695:
686:
680:
679:
677:
675:
670:. September 2006
665:
657:
651:
650:
648:
646:
621:
612:
606:
597:
596:
594:
592:
586:
577:
566:
565:
563:
561:
538:
519:
513:
507:
506:
504:
502:
479:
473:
472:
454:
448:
447:
429:
423:
422:
406:
396:
390:
389:
387:
385:
369:
344:
338:
332:
331:
329:
327:
304:
277:Scope management
209:perspective for
132:Assess / analyze
106:Assess / analyze
67:electrical power
862:
861:
857:
856:
855:
853:
852:
851:
827:
826:
810:
806:
793:
790:
785:
784:
774:
772:
763:
762:
758:
748:
746:
741:
740:
736:
726:
724:
721:
713:
712:
708:
698:
696:
693:
688:
687:
683:
673:
671:
663:
659:
658:
654:
644:
642:
640:
623:
622:
615:
607:
600:
590:
588:
584:
579:
578:
569:
559:
557:
555:
540:
539:
522:
514:
510:
500:
498:
496:
481:
480:
476:
469:
456:
455:
451:
444:
431:
430:
426:
419:
398:
397:
393:
383:
381:
371:
370:
347:
339:
335:
325:
323:
321:
306:
305:
290:
285:
272:Standardization
262:Living document
252:Version control
223:
211:clinical trials
194:
185:
176:
159:
143:
134:
125:
86:
24:
21:version control
17:
12:
11:
5:
860:
858:
850:
849:
844:
839:
829:
828:
825:
824:
804:
789:
786:
783:
782:
756:
734:
706:
681:
652:
638:
613:
598:
567:
553:
520:
508:
494:
474:
467:
449:
442:
424:
417:
391:
345:
333:
319:
287:
286:
284:
281:
280:
279:
274:
269:
264:
259:
254:
249:
244:
239:
234:
229:
227:Change request
222:
219:
193:
190:
184:
181:
175:
172:
158:
155:
142:
139:
133:
130:
124:
121:
120:
119:
116:
113:
110:
107:
104:
85:
82:
71:infrastructure
36:change control
34:(IT) systems,
15:
13:
10:
9:
6:
4:
3:
2:
859:
848:
845:
843:
840:
838:
835:
834:
832:
821:
815:
807:
801:
797:
792:
791:
787:
770:
766:
760:
757:
745:
738:
735:
720:
716:
710:
707:
692:
685:
682:
669:
662:
656:
653:
641:
639:9781932159110
635:
631:
627:
620:
618:
614:
610:
605:
603:
599:
583:
576:
574:
572:
568:
556:
554:9781932159110
550:
546:
545:
537:
535:
533:
531:
529:
527:
525:
521:
517:
512:
509:
497:
495:9781938904356
491:
487:
486:
478:
475:
470:
468:9780824795740
464:
460:
453:
450:
445:
443:9781466503557
439:
435:
428:
425:
420:
418:9780849320613
414:
410:
405:
404:
395:
392:
379:
375:
368:
366:
364:
362:
360:
358:
356:
354:
352:
350:
346:
342:
337:
334:
322:
320:9781844803545
316:
312:
311:
303:
301:
299:
297:
295:
293:
289:
282:
278:
275:
273:
270:
268:
265:
263:
260:
258:
255:
253:
250:
248:
245:
243:
242:Documentation
240:
238:
235:
233:
230:
228:
225:
224:
220:
218:
216:
212:
208:
204:
199:
191:
189:
182:
180:
173:
171:
169:
165:
156:
154:
152:
151:business case
148:
140:
138:
131:
129:
122:
117:
114:
111:
108:
105:
102:
101:
100:
97:
95:
91:
83:
81:
79:
74:
72:
68:
64:
60:
56:
52:
46:
44:
43:
37:
33:
29:
22:
795:
773:. Retrieved
771:. April 1999
759:
747:. Retrieved
737:
725:. Retrieved
709:
697:. Retrieved
684:
672:. Retrieved
655:
643:. Retrieved
629:
589:. Retrieved
558:. Retrieved
543:
511:
499:. Retrieved
484:
477:
458:
452:
433:
427:
402:
394:
382:. Retrieved
378:TechRepublic
377:
336:
324:. Retrieved
309:
232:Change order
195:
186:
177:
160:
157:Build / test
144:
135:
126:
123:Plan / scope
112:Build / test
103:Plan / scope
98:
87:
75:
47:
41:
35:
25:
205:. From the
84:The process
831:Categories
788:References
689:Infusion.
247:Identifier
217:document.
30:(QMS) and
814:cite book
283:Citations
257:Changelog
174:Implement
115:Implement
749:28 April
727:20 April
699:28 April
221:See also
51:computer
674:12 July
166:and/or
63:routing
55:network
26:Within
802:
775:13 May
645:20 May
636:
591:20 May
560:20 May
551:
501:20 May
492:
465:
440:
415:
384:20 May
326:20 May
317:
722:(PDF)
694:(PDF)
664:(PDF)
585:(PDF)
196:In a
183:Close
118:Close
820:link
800:ISBN
777:2021
751:2009
729:2011
701:2009
676:2009
647:2018
634:ISBN
593:2018
562:2018
549:ISBN
503:2018
490:ISBN
463:ISBN
438:ISBN
413:ISBN
386:2018
328:2018
315:ISBN
203:SOPs
164:unit
78:ITIL
53:and
715:ICH
409:200
833::
816:}}
812:{{
767:.
717:.
666:.
628:.
616:^
601:^
570:^
523:^
411:.
376:.
348:^
291:^
92:,
73:.
822:)
808:.
779:.
753:.
731:.
703:.
678:.
649:.
595:.
564:.
505:.
471:.
446:.
421:.
388:.
330:.
23:.
Text is available under the Creative Commons Attribution-ShareAlike License. Additional terms may apply.