SlideShare uma empresa Scribd logo
1 de 10
IT Change Control  Process 18 August 2005 [email_address]
Why Does UD Require IT Change Controls To maintain the IT systems in a Validated State. To provide proof to our customers/suppliers/auditors that UD and IT --WORK TOGETHER-- to a formal process. To allow UD management to review and be informed of interdepartmental workflow and requests for change. To minimise cost of change by clearly specifying requirements prior to implementation and installation  (cost of ownership).
Cost/Effort Of A Change Request (from Boehm, Barry W.  Software Engineering Economics . Englewood Cliffs, NJ:  Prentice-Hall, 1981) 0 10 20 30 40 50 60 70 Requirements Design Code Development Testing Acceptance Testing Operation Development Phase Cost/Effort  to Correct a Problem
What Is An IT Change Control System ? ,[object Object],[object Object],[object Object]
Change Control Boards (CCBs) ,[object Object],[object Object],[object Object],[object Object]
Control Board Function ,[object Object],[object Object],[object Object],[object Object]
What are the advantages of a change control board ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
The Change Control Process Loop
A Compliant CCP ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Proposal For UDD  ,[object Object],[object Object],[object Object],[object Object]

Mais conteúdo relacionado

Mais procurados

Pharmaceutical process validation (PV)
Pharmaceutical process validation (PV)  Pharmaceutical process validation (PV)
Pharmaceutical process validation (PV) Guru Balaji .S
 
Change Management in Pharmaeutical Manufacturing Operations (Full Day Session)
Change Management in Pharmaeutical Manufacturing Operations (Full Day Session)Change Management in Pharmaeutical Manufacturing Operations (Full Day Session)
Change Management in Pharmaeutical Manufacturing Operations (Full Day Session)Obaid Ali / Roohi B. Obaid
 
Computer System Validation is not mere testing
Computer System Validation is not mere testingComputer System Validation is not mere testing
Computer System Validation is not mere testingAnand Rao. C
 
Gmp change control by amsavel
Gmp  change control  by amsavelGmp  change control  by amsavel
Gmp change control by amsavelAmsavel Vel
 
Risk assessment for computer system validation
Risk assessment for computer system validationRisk assessment for computer system validation
Risk assessment for computer system validationBangaluru
 
V model concept of validation
V model concept of validation V model concept of validation
V model concept of validation Guru Balaji .S
 
Computer System Validation - The Validation Master Plan
Computer System Validation - The Validation Master PlanComputer System Validation - The Validation Master Plan
Computer System Validation - The Validation Master PlanWolfgang Kuchinke
 
Computer System Validation
Computer System ValidationComputer System Validation
Computer System ValidationEric Silva
 
Understanding the Medical device Single Audit Program (MDSAP) & How to Prepar...
Understanding the Medical device Single Audit Program (MDSAP) & How to Prepar...Understanding the Medical device Single Audit Program (MDSAP) & How to Prepar...
Understanding the Medical device Single Audit Program (MDSAP) & How to Prepar...Greenlight Guru
 
GMP- APQR training
GMP- APQR  trainingGMP- APQR  training
GMP- APQR trainingAmsavel Vel
 
CCF PPT By Amit Gupta.pptx
CCF PPT By Amit Gupta.pptxCCF PPT By Amit Gupta.pptx
CCF PPT By Amit Gupta.pptxamitgupta273294
 
GxP Assessment.docx
GxP Assessment.docxGxP Assessment.docx
GxP Assessment.docxWisdo2
 
Computerized system validation_final
Computerized system validation_finalComputerized system validation_final
Computerized system validation_finalDuy Tan Geek
 
Change management system
Change management systemChange management system
Change management systemmanusb07
 
Computerized system validation (CSV) as a requirement for good manufacturing ...
Computerized system validation (CSV) as a requirement for good manufacturing ...Computerized system validation (CSV) as a requirement for good manufacturing ...
Computerized system validation (CSV) as a requirement for good manufacturing ...Ahmed Hasham
 
Deviation and root cause analysis in Pharma
Deviation and root cause analysis in PharmaDeviation and root cause analysis in Pharma
Deviation and root cause analysis in PharmaSubhash Sanghani
 

Mais procurados (20)

Computer System Validation
Computer System ValidationComputer System Validation
Computer System Validation
 
Pharmaceutical process validation (PV)
Pharmaceutical process validation (PV)  Pharmaceutical process validation (PV)
Pharmaceutical process validation (PV)
 
Gamp5 new
Gamp5 newGamp5 new
Gamp5 new
 
change control
change controlchange control
change control
 
Change Management in Pharmaeutical Manufacturing Operations (Full Day Session)
Change Management in Pharmaeutical Manufacturing Operations (Full Day Session)Change Management in Pharmaeutical Manufacturing Operations (Full Day Session)
Change Management in Pharmaeutical Manufacturing Operations (Full Day Session)
 
Computer System Validation is not mere testing
Computer System Validation is not mere testingComputer System Validation is not mere testing
Computer System Validation is not mere testing
 
Gmp change control by amsavel
Gmp  change control  by amsavelGmp  change control  by amsavel
Gmp change control by amsavel
 
Risk assessment for computer system validation
Risk assessment for computer system validationRisk assessment for computer system validation
Risk assessment for computer system validation
 
V model concept of validation
V model concept of validation V model concept of validation
V model concept of validation
 
Computer System Validation - The Validation Master Plan
Computer System Validation - The Validation Master PlanComputer System Validation - The Validation Master Plan
Computer System Validation - The Validation Master Plan
 
Computer System Validation
Computer System ValidationComputer System Validation
Computer System Validation
 
Understanding the Medical device Single Audit Program (MDSAP) & How to Prepar...
Understanding the Medical device Single Audit Program (MDSAP) & How to Prepar...Understanding the Medical device Single Audit Program (MDSAP) & How to Prepar...
Understanding the Medical device Single Audit Program (MDSAP) & How to Prepar...
 
GMP- APQR training
GMP- APQR  trainingGMP- APQR  training
GMP- APQR training
 
CCF PPT By Amit Gupta.pptx
CCF PPT By Amit Gupta.pptxCCF PPT By Amit Gupta.pptx
CCF PPT By Amit Gupta.pptx
 
GxP Assessment.docx
GxP Assessment.docxGxP Assessment.docx
GxP Assessment.docx
 
Computerized system validation_final
Computerized system validation_finalComputerized system validation_final
Computerized system validation_final
 
Change management system
Change management systemChange management system
Change management system
 
Computerized system validation (CSV) as a requirement for good manufacturing ...
Computerized system validation (CSV) as a requirement for good manufacturing ...Computerized system validation (CSV) as a requirement for good manufacturing ...
Computerized system validation (CSV) as a requirement for good manufacturing ...
 
CMA, CQA, CPP
CMA, CQA, CPPCMA, CQA, CPP
CMA, CQA, CPP
 
Deviation and root cause analysis in Pharma
Deviation and root cause analysis in PharmaDeviation and root cause analysis in Pharma
Deviation and root cause analysis in Pharma
 

Semelhante a IT Change Control Process

SDLC Control
SDLC ControlSDLC Control
SDLC Controlbenji00
 
Presentation to the AEA (June 23)
Presentation to the AEA (June 23) Presentation to the AEA (June 23)
Presentation to the AEA (June 23) Daljit Banger
 
P2 how to develop an it change management program
P2 how to develop an it change management programP2 how to develop an it change management program
P2 how to develop an it change management programIT-Toolkits.org
 
Engineering Change Management - Overview and Best Practices
Engineering Change Management - Overview and Best PracticesEngineering Change Management - Overview and Best Practices
Engineering Change Management - Overview and Best PracticesShobhit Singhal
 
293504541-ict-its4-03-0811-assist-with-policy-development-for-client-support-...
293504541-ict-its4-03-0811-assist-with-policy-development-for-client-support-...293504541-ict-its4-03-0811-assist-with-policy-development-for-client-support-...
293504541-ict-its4-03-0811-assist-with-policy-development-for-client-support-...kndnewguade
 
Change Management - ITIL
Change Management - ITILChange Management - ITIL
Change Management - ITILconnorsmaureen
 
Achieving IT Governance and compliance using Kovair
Achieving IT Governance and compliance using KovairAchieving IT Governance and compliance using Kovair
Achieving IT Governance and compliance using KovairKovair
 
Requirement change management
Requirement change managementRequirement change management
Requirement change managementAbdul Basit
 
5 itil v3 service transition 5 v1.8
5 itil v3 service transition 5 v1.85 itil v3 service transition 5 v1.8
5 itil v3 service transition 5 v1.8Karthik Arumugham
 
IS Change& knowledge Management Processes AwarnessTraining PPT June 2023-draf...
IS Change& knowledge Management Processes AwarnessTraining PPT June 2023-draf...IS Change& knowledge Management Processes AwarnessTraining PPT June 2023-draf...
IS Change& knowledge Management Processes AwarnessTraining PPT June 2023-draf...OmnaCool
 
Optimize your Change Management Process
Optimize your Change Management ProcessOptimize your Change Management Process
Optimize your Change Management ProcessJason Goncalves
 
A framework for streamlining globally integrated services
A framework for streamlining globally integrated servicesA framework for streamlining globally integrated services
A framework for streamlining globally integrated servicesAli Elkhateb
 
Services Industry Case Study: A Practical Approach To Process Automation
Services Industry Case Study: A Practical Approach To Process AutomationServices Industry Case Study: A Practical Approach To Process Automation
Services Industry Case Study: A Practical Approach To Process AutomationNathaniel Palmer
 
SFHDI presents: Numara Software - Change & Approval Management
SFHDI presents: Numara  Software - Change & Approval ManagementSFHDI presents: Numara  Software - Change & Approval Management
SFHDI presents: Numara Software - Change & Approval ManagementSan Francisco Bay Area
 
ChangeManagementTraining
ChangeManagementTrainingChangeManagementTraining
ChangeManagementTrainingMichael Perry
 
Itil a guide to cab meetings pdf
Itil a guide to cab meetings pdfItil a guide to cab meetings pdf
Itil a guide to cab meetings pdfwardell henley
 
Assisit with devlopment.pptx
Assisit with devlopment.pptxAssisit with devlopment.pptx
Assisit with devlopment.pptxTadeseBeyene
 

Semelhante a IT Change Control Process (20)

SDLC Control
SDLC ControlSDLC Control
SDLC Control
 
Presentation to the AEA (June 23)
Presentation to the AEA (June 23) Presentation to the AEA (June 23)
Presentation to the AEA (June 23)
 
P2 how to develop an it change management program
P2 how to develop an it change management programP2 how to develop an it change management program
P2 how to develop an it change management program
 
Engineering Change Management - Overview and Best Practices
Engineering Change Management - Overview and Best PracticesEngineering Change Management - Overview and Best Practices
Engineering Change Management - Overview and Best Practices
 
293504541-ict-its4-03-0811-assist-with-policy-development-for-client-support-...
293504541-ict-its4-03-0811-assist-with-policy-development-for-client-support-...293504541-ict-its4-03-0811-assist-with-policy-development-for-client-support-...
293504541-ict-its4-03-0811-assist-with-policy-development-for-client-support-...
 
Change Management - ITIL
Change Management - ITILChange Management - ITIL
Change Management - ITIL
 
Itil prc review
Itil prc reviewItil prc review
Itil prc review
 
Achieving IT Governance and compliance using Kovair
Achieving IT Governance and compliance using KovairAchieving IT Governance and compliance using Kovair
Achieving IT Governance and compliance using Kovair
 
Requirement change management
Requirement change managementRequirement change management
Requirement change management
 
PACE-IT: Basics of Change Management
PACE-IT: Basics of Change ManagementPACE-IT: Basics of Change Management
PACE-IT: Basics of Change Management
 
5 itil v3 service transition 5 v1.8
5 itil v3 service transition 5 v1.85 itil v3 service transition 5 v1.8
5 itil v3 service transition 5 v1.8
 
IS Change& knowledge Management Processes AwarnessTraining PPT June 2023-draf...
IS Change& knowledge Management Processes AwarnessTraining PPT June 2023-draf...IS Change& knowledge Management Processes AwarnessTraining PPT June 2023-draf...
IS Change& knowledge Management Processes AwarnessTraining PPT June 2023-draf...
 
Optimize your Change Management Process
Optimize your Change Management ProcessOptimize your Change Management Process
Optimize your Change Management Process
 
A framework for streamlining globally integrated services
A framework for streamlining globally integrated servicesA framework for streamlining globally integrated services
A framework for streamlining globally integrated services
 
Services Industry Case Study: A Practical Approach To Process Automation
Services Industry Case Study: A Practical Approach To Process AutomationServices Industry Case Study: A Practical Approach To Process Automation
Services Industry Case Study: A Practical Approach To Process Automation
 
Numara change & approval mgmt
Numara change & approval mgmtNumara change & approval mgmt
Numara change & approval mgmt
 
SFHDI presents: Numara Software - Change & Approval Management
SFHDI presents: Numara  Software - Change & Approval ManagementSFHDI presents: Numara  Software - Change & Approval Management
SFHDI presents: Numara Software - Change & Approval Management
 
ChangeManagementTraining
ChangeManagementTrainingChangeManagementTraining
ChangeManagementTraining
 
Itil a guide to cab meetings pdf
Itil a guide to cab meetings pdfItil a guide to cab meetings pdf
Itil a guide to cab meetings pdf
 
Assisit with devlopment.pptx
Assisit with devlopment.pptxAssisit with devlopment.pptx
Assisit with devlopment.pptx
 

Último

Best VIP Call Girls Noida Sector 40 Call Me: 8448380779
Best VIP Call Girls Noida Sector 40 Call Me: 8448380779Best VIP Call Girls Noida Sector 40 Call Me: 8448380779
Best VIP Call Girls Noida Sector 40 Call Me: 8448380779Delhi Call girls
 
The Coffee Bean & Tea Leaf(CBTL), Business strategy case study
The Coffee Bean & Tea Leaf(CBTL), Business strategy case studyThe Coffee Bean & Tea Leaf(CBTL), Business strategy case study
The Coffee Bean & Tea Leaf(CBTL), Business strategy case studyEthan lee
 
Regression analysis: Simple Linear Regression Multiple Linear Regression
Regression analysis:  Simple Linear Regression Multiple Linear RegressionRegression analysis:  Simple Linear Regression Multiple Linear Regression
Regression analysis: Simple Linear Regression Multiple Linear RegressionRavindra Nath Shukla
 
Mysore Call Girls 8617370543 WhatsApp Number 24x7 Best Services
Mysore Call Girls 8617370543 WhatsApp Number 24x7 Best ServicesMysore Call Girls 8617370543 WhatsApp Number 24x7 Best Services
Mysore Call Girls 8617370543 WhatsApp Number 24x7 Best ServicesDipal Arora
 
Ensure the security of your HCL environment by applying the Zero Trust princi...
Ensure the security of your HCL environment by applying the Zero Trust princi...Ensure the security of your HCL environment by applying the Zero Trust princi...
Ensure the security of your HCL environment by applying the Zero Trust princi...Roland Driesen
 
Best Basmati Rice Manufacturers in India
Best Basmati Rice Manufacturers in IndiaBest Basmati Rice Manufacturers in India
Best Basmati Rice Manufacturers in IndiaShree Krishna Exports
 
0183760ssssssssssssssssssssssssssss00101011 (27).pdf
0183760ssssssssssssssssssssssssssss00101011 (27).pdf0183760ssssssssssssssssssssssssssss00101011 (27).pdf
0183760ssssssssssssssssssssssssssss00101011 (27).pdfRenandantas16
 
Progress Report - Oracle Database Analyst Summit
Progress  Report - Oracle Database Analyst SummitProgress  Report - Oracle Database Analyst Summit
Progress Report - Oracle Database Analyst SummitHolger Mueller
 
Grateful 7 speech thanking everyone that has helped.pdf
Grateful 7 speech thanking everyone that has helped.pdfGrateful 7 speech thanking everyone that has helped.pdf
Grateful 7 speech thanking everyone that has helped.pdfPaul Menig
 
Call Girls In DLf Gurgaon ➥99902@11544 ( Best price)100% Genuine Escort In 24...
Call Girls In DLf Gurgaon ➥99902@11544 ( Best price)100% Genuine Escort In 24...Call Girls In DLf Gurgaon ➥99902@11544 ( Best price)100% Genuine Escort In 24...
Call Girls In DLf Gurgaon ➥99902@11544 ( Best price)100% Genuine Escort In 24...lizamodels9
 
Boost the utilization of your HCL environment by reevaluating use cases and f...
Boost the utilization of your HCL environment by reevaluating use cases and f...Boost the utilization of your HCL environment by reevaluating use cases and f...
Boost the utilization of your HCL environment by reevaluating use cases and f...Roland Driesen
 
Understanding the Pakistan Budgeting Process: Basics and Key Insights
Understanding the Pakistan Budgeting Process: Basics and Key InsightsUnderstanding the Pakistan Budgeting Process: Basics and Key Insights
Understanding the Pakistan Budgeting Process: Basics and Key Insightsseri bangash
 
RSA Conference Exhibitor List 2024 - Exhibitors Data
RSA Conference Exhibitor List 2024 - Exhibitors DataRSA Conference Exhibitor List 2024 - Exhibitors Data
RSA Conference Exhibitor List 2024 - Exhibitors DataExhibitors Data
 
Unlocking the Secrets of Affiliate Marketing.pdf
Unlocking the Secrets of Affiliate Marketing.pdfUnlocking the Secrets of Affiliate Marketing.pdf
Unlocking the Secrets of Affiliate Marketing.pdfOnline Income Engine
 
M.C Lodges -- Guest House in Jhang.
M.C Lodges --  Guest House in Jhang.M.C Lodges --  Guest House in Jhang.
M.C Lodges -- Guest House in Jhang.Aaiza Hassan
 
Value Proposition canvas- Customer needs and pains
Value Proposition canvas- Customer needs and painsValue Proposition canvas- Customer needs and pains
Value Proposition canvas- Customer needs and painsP&CO
 
Pharma Works Profile of Karan Communications
Pharma Works Profile of Karan CommunicationsPharma Works Profile of Karan Communications
Pharma Works Profile of Karan Communicationskarancommunications
 

Último (20)

Best VIP Call Girls Noida Sector 40 Call Me: 8448380779
Best VIP Call Girls Noida Sector 40 Call Me: 8448380779Best VIP Call Girls Noida Sector 40 Call Me: 8448380779
Best VIP Call Girls Noida Sector 40 Call Me: 8448380779
 
The Coffee Bean & Tea Leaf(CBTL), Business strategy case study
The Coffee Bean & Tea Leaf(CBTL), Business strategy case studyThe Coffee Bean & Tea Leaf(CBTL), Business strategy case study
The Coffee Bean & Tea Leaf(CBTL), Business strategy case study
 
Regression analysis: Simple Linear Regression Multiple Linear Regression
Regression analysis:  Simple Linear Regression Multiple Linear RegressionRegression analysis:  Simple Linear Regression Multiple Linear Regression
Regression analysis: Simple Linear Regression Multiple Linear Regression
 
Mysore Call Girls 8617370543 WhatsApp Number 24x7 Best Services
Mysore Call Girls 8617370543 WhatsApp Number 24x7 Best ServicesMysore Call Girls 8617370543 WhatsApp Number 24x7 Best Services
Mysore Call Girls 8617370543 WhatsApp Number 24x7 Best Services
 
Ensure the security of your HCL environment by applying the Zero Trust princi...
Ensure the security of your HCL environment by applying the Zero Trust princi...Ensure the security of your HCL environment by applying the Zero Trust princi...
Ensure the security of your HCL environment by applying the Zero Trust princi...
 
Best Basmati Rice Manufacturers in India
Best Basmati Rice Manufacturers in IndiaBest Basmati Rice Manufacturers in India
Best Basmati Rice Manufacturers in India
 
0183760ssssssssssssssssssssssssssss00101011 (27).pdf
0183760ssssssssssssssssssssssssssss00101011 (27).pdf0183760ssssssssssssssssssssssssssss00101011 (27).pdf
0183760ssssssssssssssssssssssssssss00101011 (27).pdf
 
Progress Report - Oracle Database Analyst Summit
Progress  Report - Oracle Database Analyst SummitProgress  Report - Oracle Database Analyst Summit
Progress Report - Oracle Database Analyst Summit
 
Grateful 7 speech thanking everyone that has helped.pdf
Grateful 7 speech thanking everyone that has helped.pdfGrateful 7 speech thanking everyone that has helped.pdf
Grateful 7 speech thanking everyone that has helped.pdf
 
Call Girls In DLf Gurgaon ➥99902@11544 ( Best price)100% Genuine Escort In 24...
Call Girls In DLf Gurgaon ➥99902@11544 ( Best price)100% Genuine Escort In 24...Call Girls In DLf Gurgaon ➥99902@11544 ( Best price)100% Genuine Escort In 24...
Call Girls In DLf Gurgaon ➥99902@11544 ( Best price)100% Genuine Escort In 24...
 
VVVIP Call Girls In Greater Kailash ➡️ Delhi ➡️ 9999965857 🚀 No Advance 24HRS...
VVVIP Call Girls In Greater Kailash ➡️ Delhi ➡️ 9999965857 🚀 No Advance 24HRS...VVVIP Call Girls In Greater Kailash ➡️ Delhi ➡️ 9999965857 🚀 No Advance 24HRS...
VVVIP Call Girls In Greater Kailash ➡️ Delhi ➡️ 9999965857 🚀 No Advance 24HRS...
 
Boost the utilization of your HCL environment by reevaluating use cases and f...
Boost the utilization of your HCL environment by reevaluating use cases and f...Boost the utilization of your HCL environment by reevaluating use cases and f...
Boost the utilization of your HCL environment by reevaluating use cases and f...
 
unwanted pregnancy Kit [+918133066128] Abortion Pills IN Dubai UAE Abudhabi
unwanted pregnancy Kit [+918133066128] Abortion Pills IN Dubai UAE Abudhabiunwanted pregnancy Kit [+918133066128] Abortion Pills IN Dubai UAE Abudhabi
unwanted pregnancy Kit [+918133066128] Abortion Pills IN Dubai UAE Abudhabi
 
Understanding the Pakistan Budgeting Process: Basics and Key Insights
Understanding the Pakistan Budgeting Process: Basics and Key InsightsUnderstanding the Pakistan Budgeting Process: Basics and Key Insights
Understanding the Pakistan Budgeting Process: Basics and Key Insights
 
RSA Conference Exhibitor List 2024 - Exhibitors Data
RSA Conference Exhibitor List 2024 - Exhibitors DataRSA Conference Exhibitor List 2024 - Exhibitors Data
RSA Conference Exhibitor List 2024 - Exhibitors Data
 
Unlocking the Secrets of Affiliate Marketing.pdf
Unlocking the Secrets of Affiliate Marketing.pdfUnlocking the Secrets of Affiliate Marketing.pdf
Unlocking the Secrets of Affiliate Marketing.pdf
 
M.C Lodges -- Guest House in Jhang.
M.C Lodges --  Guest House in Jhang.M.C Lodges --  Guest House in Jhang.
M.C Lodges -- Guest House in Jhang.
 
Value Proposition canvas- Customer needs and pains
Value Proposition canvas- Customer needs and painsValue Proposition canvas- Customer needs and pains
Value Proposition canvas- Customer needs and pains
 
Pharma Works Profile of Karan Communications
Pharma Works Profile of Karan CommunicationsPharma Works Profile of Karan Communications
Pharma Works Profile of Karan Communications
 
Forklift Operations: Safety through Cartoons
Forklift Operations: Safety through CartoonsForklift Operations: Safety through Cartoons
Forklift Operations: Safety through Cartoons
 

IT Change Control Process

  • 1. IT Change Control Process 18 August 2005 [email_address]
  • 2. Why Does UD Require IT Change Controls To maintain the IT systems in a Validated State. To provide proof to our customers/suppliers/auditors that UD and IT --WORK TOGETHER-- to a formal process. To allow UD management to review and be informed of interdepartmental workflow and requests for change. To minimise cost of change by clearly specifying requirements prior to implementation and installation (cost of ownership).
  • 3. Cost/Effort Of A Change Request (from Boehm, Barry W. Software Engineering Economics . Englewood Cliffs, NJ: Prentice-Hall, 1981) 0 10 20 30 40 50 60 70 Requirements Design Code Development Testing Acceptance Testing Operation Development Phase Cost/Effort to Correct a Problem
  • 4.
  • 5.
  • 6.
  • 7.
  • 8. The Change Control Process Loop
  • 9.
  • 10.