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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

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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)

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2

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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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