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12/4/2009
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Stakeholders’ identification: key success factor for the implementation of Electronic Document Management Systems
Isabel Saez-PujolDirector, Informatics & Knowledge ManagementDaiichi Sankyo Development, Ltd.
The views and opinions expressed in the following PowerPoint slides arethose of the individual presenter and should not be attributed to Drug
Disclaimer
those of the individual presenter and should not be attributed to DrugInformation Association, Inc. (“DIA”), its directors, officers, employees,volunteers, members, chapters, councils, Special Interest Area Communitiesor affiliates, or any organization with which the presenter is employed oraffiliated.
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Presentation outline
• Factors influencing Electronic Document• Factors influencing Electronic Document Management Systems (EDMS) implementations
• Case Study 1 – Project “A”• Case Study 2 – Project “B”
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Factors influencing implementations• Before system go-live:
– Stakeholder Identification and Participation – Commitment and Leadership – Scope management
• After system go-live:User perception of system need
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– User perception of system need– Time, rewards and incentives – Technology / people / processes– Training and end-user support
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Stakeholder identification & participation• Users must become
" k h ld “"stakeholders“• Give them the opportunity
to participate in decisions concerning the system
• When individuals "buy-in“, they possess "ownership"
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t ey possess o e s pof the idea and become facilitators in making the implementation successful
Commitment and Leadership
• Commitment must be displayed by p y yindividuals involved in the implementation at all levels
Should be identified as Stakeholders
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• Leadership support is key to successful systems’ implementations
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• "scope creep“ - can be minimised b
Scope management
minimised by:– Stakeholder identification– Clear scope changes
escalation procedures • changes prioritisation
(G P/N G P)
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(GxP/Non-GxP)• Steering Committee approval
User perception of system need• Technology should not be adopted for
its o n sake a gen ine need m stits own sake - a genuine need must exist
• Users will use technology once they understand how it can make them more productive
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p
• Users are stakeholders. A communication plan to stakeholders needs to be established.
• User representatives (per function) should also be part of the project team
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Time, rewards and incentives
• Mastering technology requires time• Users have very little time (and patience) for
experimenting with new technologies • Creative ways to provide time for users to play
with new technology:– Encouraged through the use of rewards and
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incentives– Formal recognition of their technology endeavours
Technology / people / processes
People / Resources
Methodology / Processes
Technology
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Training and end user support
• Users must feel confident in the operation of the technology and their own ability to integrate it into daily processes
• Train, train and re-train• User support can be divided into layers:
Q ti
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Question
Business question
Super-user(Functional Liaisons)
Business Owner
Technical question
IT HelpDesk Information System Owner
System Administrator
Case Study 1 – Project “A”• Project Specifications• Factors influencing the implementation
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Project Specifications (1)
System EDMS implementation
Goal Deliver a local database for Regulatory Affairs to create, store and archive documents and interface with an electronic Publishing tool.
Use Use:–Regulatory Affairs, Clinical Development – approximately 20 users
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approximately 20 users
Location:– 1 US location
Project Specifications (2)
Time 4 months (in 2002)Time ( )
Budget Fixed budget
Constraints Validation required:–21 CFR Part 11–ICH guidelines
Project 5 team members:
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jTeam –Validation Lead – from vendor
–Quality Assurance – from vendor–Sponsor – from Regulatory Affairs–Project Manager – from Document Management–Technical support – from Information Services
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Factors influencing implementations• Before system go-live:
– Stakeholder Identification and Participation – Commitment and Leadership – Scope management
• After system go-live:User perception of system need
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– User perception of system need– Time, rewards and incentives – Technology / people / processes– Training and end-user support
Case Study 2 – Project “B”• Project Specifications• Project Team• Factors influencing the implementation
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Project Specifications (1)
System EDMS Configuration
Goal Deliver a single regional (US/EU) database for all key documents (intended for Regulatory Submissions)
Use Multi-functional use:–Regulatory Affairs, Quality Assurance, Project
Management, Clinical Development, Development
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g p pResearch, Biostatistics & Data Operations, Translational Medicine & Clinical Pharmacology, Medical and Technical Writing, etc.
International locations:–Europe 2 locations, USA 2 locations
Project Specifications (2)
Time 9 months (2007-2008) TimeTime ( )
Budget Fixed budget
Constraints Validation required:–21 CFR Part 11–ICH guidelines
Project Remote Project Management:
Time
QualityCost
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Project Team
j g–Project Manager in the UK–Project Team in the US (same US location)
Multi-cultural implementation team from:–America, Spain, China and India
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Project TeamSteering
Committee
Role Defined in company procedures
Role mentioned but not defined in company procedures
4Committee
(Senior Management)
Business Owner
(Business Function)
Information Systems
Project Manager
(I f ti )Computeris
d S t
company proceduresRole not mentioned or defined in
company procedures
0.50.5
2
2112
5
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Project Team Validation Team
Owner(Informatics)
(Informatics)ed System Owner
(Business Function)
IT Application & Services(IT Appl. & Services)
Validation Lead
(Consultant)
Technical Lead
(Consultant)
Quality Assurance(Regulatory Affairs & Risk Mangment.)
Functional Liaisons(Business Function)
3
2
1
Factors influencing the implementationBefore system go-live (1):• Stakeholders’ identification and participation:
– Identification:• Departments involved identified by Business Owner(s)• Departmental representation identified by Management
– Communication plan in Project Charter:
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• Weekly (+ad hoc) Validation Team meetings• Monthly meetings with Functional Liaisons• Functional Liaisons responsible for departmental communication• Monthly Status report sent to Steering Committee• Meetings with vendors as needed
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Factors influencing the implementation
Before system go-live (2):y g ( )• Commitment and Leadership
– Steering Committee approach• Scope management
• Scope changes rejected – some would be implemented as Change Controls after system “go
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implemented as Change Controls after system go-live”.
Factors influencing the implementationAfter system go-live:• User perception of system need• Time, rewards and incentives
• Part of employees objectives• Technology / people / processes
• Updated company procedures
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p p y p• Training and end-user support
• Content Management training• Functional Liaisons / Content Management support• IT Help Desk / System Administrator
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Projects ComparisonCase Study 1 – Project “A” Case Study 2 – Project “B”Si l d t t P d fi d d t tSingle document type• Difficult to search• No document specific attributes• Unlimited scope for document type
Pre-defined document types• Search capability improved per
document type and attributes• Attributes specific to document type
Freedom of classification• Users unable to find documentation
Pre-defined classification based on document type
• Facilitates User familiarity with folder structure and navigation
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20 users 200 usersElectronic signatures
~100,000 documents in repositories >250,000 documents in repository
Lessons Learned• Stakeholders involvement can make the
difference between success and failure:difference between success and failure:– Identify Stakeholders– Prepare a Stakeholders’ communication plan based on
level of prioritisation– Involve Stakeholders’ to participate in the project
before go-live and after go-live
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