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SAP Project Kick-Off

“EzLifeSciences” An SAP S/4HANA Business All-In-One Solution

September 26, 2018


Goals and Objectives

 Today’s objective is to set the stage for the Repligen SAP Initiative. Together, we will :

– Review the Projects Overall Scope, Approach, and Roles & Responsibilities

– Introduce the Explore / Design Stage

– Introduce and review Organizational Structure

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© 2018 The Hackett Group, Inc. All rights reserved. Reproduction of this document or any portion thereof without prior written consent is prohibited.
– Project Overview

– EzLifeSciencesTM Overview
Agenda – Approach

– Implementation Methodology

– Validation

– Organization & Staffing

– Next Steps

3
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Revised Project Timeline

 Phase 1 is a 47 week project breakdown:


– Project Prep ~ 4 Weeks
 Completed by 10/5 w/ base Repligen Data
 Core Consulting team onsite week of 10/8 for BP Workshop prep
– Global Blueprint 8 Weeks
 Design Workshops Start 10/22 / Target Completion by Year End
– Realization 20 Weeks
– Final Prep 5 Weeks
– Go Live 1 4 Weeks
 Waltham & Tangenix July 2019
– Go-Live 2 3 Weeks
 Spectrum US (3 US / NL & Japan Aug 2019)

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Project Scope
 The following functionality and components of the  The implementation is based upon and will reflect
SAP solution will be required for the the following organizational setup:
implementation of SAP at Repligen: – No more than twelve (12) Legal Entities and seven (7)
Currencies for general ledger purposes
– Single Chart of Accounts (COA) based upon SAP’s
preconfigured COA
FI
PP /
QM
CO  Phase 1 - Functional Scope
EMEA
– FI – Finance (GL, AR, AP, FA)
Rollout
3rd Party – CO – Controlling (CCA, PCA, PC, IO)
AM
Integ. S/4 – HR – Human Resources (base org. structure for WF)
1709/1809 Phase ‘N’
FIORI – MM – Materials Mgmt. / Procurement / Subcontracting
– WM – Warehouse Management
SM HR
Phase 1 APAC – PP – Production Planning
Rollout – QM – Quality Management
MM/
SD – SM – Service Management
IM
PW
– PW – ProcessWeaver (shipping)
– SD – Sales and Distribution
Note: The overall project scope will be confirmed and – 3rd Party Integrations (ADP, Concur, SalesForce, Shopify,
finalized at the conclusion of the Global Blueprint. Canea One – QMS System, EDI)

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– Project Overview

– EzLifeSciencesTM Overview
Agenda – Approach

– Implementation Methodology

– Validation

– Organization & Staffing

– Next Steps

6
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EzLifeSciences™ Overview
Leveraging Answerthink’s EzLifeScience AIO Solutions
 We leverage SAP’s Industry All-In-One baseline and
Answerthink’s EzLifeSciences Industry Solution to help
digitally transform your business.
 Together, companies leverage a pre-packaged, ready-
to-use, end-to-end reference solution, tailored for your
industry needs.
 It comprises the state-of-the-art S/4 ERP 1709/1809
solution with proven business best practices and
encapsulates the experience from successful, real-life
digital transformation projects.
 Embedded in an overall transformation road map and
delivered as a service, our approach will enable
companies to reduce cost, decrease risk, and
accelerate adoption during discovery, preparation,
exploration, and realization activities.
 Encompasses a unique set of accelerators including
configuration and how-to guides, test scripts, business
process procedures, and implementation tools.

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EzLifeSciences™ Overview
Simplify, Accelerate, Innovate using our leading best practices

Accelerators Engineered service


Configuration and how-to Handover and enablement
guides, test and demo scripts, workshops to jumpstart
implementation tools discovery, exploration, and
realization

Business content Pre-configured solution


Business process hierarchy, Available as a ready-to-run
end-to-end scenarios, and appliance, including all
process diagrams by roles applications, configuration,
and sample data

Foundation

Activate Industry reference architecture Digital business framework

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© 2018 The Hackett Group, Inc. All rights reserved. Reproduction of this document or any portion thereof without prior written consent is prohibited.
– Project Overview

– EzLifeSciencesTM Overview
Agenda – Approach

– Implementation Methodology

– Validation

– Organization & Staffing

– Next Steps

9
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Approach
Project Guiding Principles
 Our overall approach is built on the following guidelines:
– Repligen will make use of leading Best Practice features. The goal is to control time, scope and cost by avoiding
configuration changes and enhancements.
– The implementation partners will leverage their solutions for maximum benefit.
 Re-engineering will only be considered if Repligen believes there is a compromise of compliance or management control.

– Global Processes will be integrated and standardized across the business


– The design will meet Repligen current requirements while still providing adequate flexibility to rapidly accommodate
future changes to Repligen operational model
– The project will be managed to minimize risk to the business and ongoing operations
– The power is in the team! Answerthink, Arbour Group, and SAP will work closely with all Repligen team members to
ensure all deliverables are of high quality and that this implementation is a success
– Answerthink, Arbour Group, and SAP are committed to sharing its experiences even if that means disagreeing with a
Repligen point of view. This “pushback” is considered “healthy debate” and will be done respectfully and for the
good of the project and Repligen

Keep things simple. Do not over-complicate.

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Approach
Key’s to Success
 LEARN ABOUT SAP
– Learn the product well, so that you’re knowledgeable and empowered for continuous improvement after go live. This applies to both
Information Technology and Business Users. Avoid the “if we don’t get it in before go live, it will never get done” syndrome. Spend
time with the consultants during the implementation for “knowledge transfer”; plan to take further SAP training post go live.
 MAKE SURE YOU’VE COVERED WHAT YOU NEED.
– Especially in blueprinting, be on the lookout for “missed requirements”. Be aware of the legacy systems being replaced and make sure
there’s an SAP (or other) equivalent replacement. It won’t necessarily be done the same way, but “must have” business requirements
and processes need to be provided for.
 TIME, TIME, TIME.
– There’s no substitute for spending time in SAP doing transactions; it’s the only way to learn the system. It’s the only way to completely
test it so that it works the way you want at Go Live. Consultant testing usually produces “pass”; real user testing is necessary. It will
probably take more time than you expect.
 DATA, DATA, DATA.
– Make sure your master data is ready and formatted for conversion. IT/IS can help, but this is primarily a business responsibility. SAP
is critically dependent on correct, complete and consistent master data. It will probably take more time than you expect.
 ROLES, ROLES, ROLES.
– Focus on Business Roles – who is going to do the transaction? Who represents them on the core team? Who will train them; how
many of them are there? How will they be supported after go live? Is this basically the same thing they do now (but in a different
system) or is it significantly different? If “significantly different” how is this change being managed and communicated? Don’t wait until
the training class to inform people that their jobs are changing significantly.

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Approach
Global ASAP
 Our approach for Repligen’s implementation is a modified version of the ASAP / Activate
methodology utilized when deploying a single global SAP footprint.

 The key aspects are:


– A global template is built once, upfront, with the involvement of resources / expertise from the various
businesses / geographies to be implemented.
– Heavy involvement from a core team of functional and technical expertise from Repligen is expected as
these individuals will have two important roles
 Ensure that the designed solution covers the requirements, and has the buy in, of all the businesses / geographies
 Learn the solution as these resources will form the backbone of the system expertise to rollout the solution and
become the eventual ‘owners’ of the processes / solution.
– A phased rollout ensures each entity is adequately supported during the implementation and overall risk
is mitigated.

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Approach
Complexity drivers for multi-site, multi-national SAP implementations

Complexity Drivers

• Global Business Issues


• Global Data Standards
• Global / Standardized Processes
• Global Products

• Geography and Cultural Issues


• Cultural differences between international sites
• Communication challenges and local acceptance (Buy-In)

• International Team Structure & Project Organization


• Internationally Balanced Teams
• Distributed Support over Regions
• Coordination of rollouts across multiple countries

• Diversity within Regional IT Systems in Use


• More complex configuration management
• Variations in Regional IT Infrastructures
• Definition of process for standards through multiple viewpoints

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Approach
Defining a Global Solution and what does it mean?
 Defining what is “Global” for Repligen
– A process is global when it is integrated throughout the enterprise
 Organization Hierarchy
 Master Data Standards (Customer, Vendor, Materials)
 Core Business Cycles (e.g. Order to Cash, Procure to Pay, Plan to Manufacture, Financials)
 Interfaces
 ‘Core’ Output Documents
 ‘Core’ Reports
 ‘Core’ Conversion Routines

 Defining what will be “Standard / Global” for Repligen


– A process is standardized if it must be executed in the same
way in the enterprise

 Defining what will be “Local” for Repligen


– A process is local if it is not possible or it makes no sense to define as global or standardized
 Local & Statutory Reporting, Local Processes, Localized Output Documents
 Tailored Data Conversion Routines

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– Project Overview

– EzLifeSciencesTM Overview
Agenda – Approach

– Implementation Methodology

– Validation

– Organization & Staffing

– Next Steps

15
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Implementation Methodology
Description of Activities by Stage

1. Prepare 2. Explore / Design 3. Realize / Build 4. Deploy / Cutover 5. Go Live Support


• Setup Infrastructure • Align business • Build and Test a • Prepare System for • Provide support for the
• Initial Planning and requirements to SAP Complete Global Production Release first month/close of go-
Preparation • Describe the solution Business and System • Prepare the Internal and live
• Define the project goals, design Environment External Organization for • Business Owns and
scope and objectives • Document solution • Develop Training Go-Live Executes New Business
• Identify, on-board and design Material and End User • Train end users Processes and Systems
train Team Members • Identify additional Documentation • Convert data • Monitor Business
functional and technical • Finalize Security Roles • Develop support plan Process Results
requirements & Profiles • Document business • Monitor Production
• Obtain business sign-off • Obtain Business processes Environment
on requirements and Approval • Conduct FDA Validation • Establish Center of
design Excellence for Support
and Enhancements

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Implementation Methodology
Summary Work Products by Wave

Wave 1 Wave 2 Wave 3 Wave 4 Support

Global Design Global Template (Pilot Sites) Rollout 1 Rollout 2

Process Harmonization across S/4HANA Core and peripheral Localized Data Cleansing and Org. Localized Data Cleansing and Org.
Repligen components Change adoption workshops Change adoption workshops

Business Process Master List AT (RICEFW/config) Country Localization (customer Country Localization (customer
specifics, legal / fiscal) specifics, legal / fiscal) AMS
Interfaces and User
End-to-end process flows based on System Integration Test cycles and System Integration Test cycles and
Integration Experience
Medical Device Best Practices User Acceptance tests User Acceptance tests
Model Company / EzLifeScience Roles and
Test Routines
Fit-to-Gap Authorizations Training of key and end users Training of key and end users
Value
Organization Roles Release added
Data Objects Data Migration from legacy to Data Migration from legacy to enhanc
Strategy
S4HANA S4HANA ements
Organization Change Impact
Catalogue & Training strategy Data Migration routines from
legacy to S4 Go-Live Prep and Cutover Go-Live Prep and Cutover
Integration strategy and landscape
Architecture Setup
System Integration test
Hypercare Hypercare AT
Master data governance and data SAP
migration, management strategy
Training content development CoE

Project Management and PMO


Value Assurance

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Implementation Methodology
Stage 1 – Prepare (Scoping & Planning)

Purpose Deliverables Milestones & Key Decisions


Initial Planning and Preparation ✓ Initial Project Plan (MS Excel)  Scope Defined
✓ Blueprint Workshop Schedule (MS Excel)  Project Team Staffed and Trained
Define the project goals, scope and objectives ✓ Kick-off Meeting Presentation (content from  Project Team Organization, Responsibilities
Identify,
Statement of Work) (MS PowerPoint) and Location
on-board and train Team Members
✓ Installed and Verified Development System  Roll-out Plan
(Physical Verification)
 System Retirement Objectives/Mandates/
Constraints
 Budget and Approach
 Key Stakeholders for Communications
Identified
 Implementation Plan in Place

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Implementation Methodology
Stage 2 – Explore (Design / Confirm the Solution)

Purpose Deliverables Milestones & Key Decisions


To create a body of work, know as Business  Business Process Design Documents (MS  Completed and signed off Process Design
Design: Word)
 Completed and signed off Solution Design
Describes the solution design  RICEF (Reporting, Interfaces, Conversions,
 Completed and signed off gap identification
Aligns
Enhancements and Forms) Requirements (MS
business requirements to the SAP and resolution
Excel)
business model
 Completed and signed off Solution
Documents
 Business Process Master List (MS Excel)
the TO-BE process models Architecture
Identifies
 Detailed Project / Resource Plan (MS Excel)
additional functional and technical  Phase Quality Assessment
requirements and any gaps  End-User Training Strategy (MS Word)
 Communication Plan
Obtains business sign-off on requirements and  System Landscape and Transport Strategy
design (MS Word)

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Implementation Methodology
Iterative Solution Design Validation

 BRD Validation with  UI Demos/Delta design  Development foundation with


EzLifeScience  Best Practice Process Demos baseline configured
 Scope Definition  Best Practice Process Flows  Scope Confirmation
 Architecture View  Business Objectives
Prerequisite:
Business Demos
Core team Best Practice
Requirement Hands on
validation Demos
Documentation Validation
of Best Design
Practice Thinking by Core
Processes team &
TO-BE Delta Business.
Solution
Validation Design
Capturing Capturing Confirmation
Sessions Capturing
feedback Workshop feedback
feedback

Establish
Resolve
BPML Key Decisions Conflicts
on modules

 Comprehensive Design Coverage


 Harmonized Global Business
 Detailed Business Process Maps  Mitigated S/4 Fitment Risks
Process Template
 Process Definition Documents  Leverage for Accelerated
 Global GAP List
Rollouts
 Key Decision Documents

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Implementation Methodology
Fit-to-Standard Workshop Approach
Consultant(s) Repligen Process

6 Expert(s)

Consultant prepares the


design document for
signature and outlines Sprint
1 Consultant explains the
Scope Confirmation, Review scope item using the SAP
and RICEFW schedules.
Best Practices.
Sprint and RICEF Best Practices
Team leverages the Baseline
EzLifeScience Best Practices to
Schedule process flow &
arrive at critical configuration concepts
decisions. All configuration values Consultant demonstrates the
required and any needed in-app scope item using the DEV
extensions are determined and system and delivered master
data and highlights the areas
documented in the backlog. The
customer is responsible for 5 Identify
required
that require configuration
decisions. The process flow is
providing value lists. i.e. product RICEF
group definition. configuration Demonstrate used as a point of reference
Backlog when transitioning in the
Scope Item
system.
&
Concepts
2
Team fosters discussion to better
Team identifies and catalogs the delta understand the customer business
requirements in the backlog for
Identify Delta Discuss how the requirements, referencing the Baseline
further analysis and closure. Delta EzLifeScience Best Practices , and to
requirements are business Requirements processes fit with the provide understanding of how the solution
requirements that cannot be satisfied customer’s meets these requirements.
with the standard scenarios.
requirements
4
3 21
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Implementation Methodology
Stage 3 – Realize (Build the Solution)

Purpose Deliverables Milestones & Key Decisions


Build and Test a Complete Business and  Sprint Schedule  Project Team Trained (Realization)
System Environment  Test Scenarios / Scripts  Final Design and Configuration
DevelopTraining Material and End User  Sprint Results  Integration Test
Documentation
 Development Plan  End-User System Infrastructure
Obtain Business Approval
 Detail Cut-over Plan  User Acceptance
 User Role and Authorization Concept  Phase Quality Assessment
 Updated End User Training Plan  Readiness Review
 End-User Documentation
 Integration Test Results
 Installed and Verified Quality Assurance
System (Physical System)
 Installed and Verified Production System
(Physical System)

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Realize Phase
Approach / Schedule of Work
 A ‘SPRINT’ is a demonstration of the SAP functionality and personalizations proposed for a given cycle.
 The Repligen SAP solution will follow best practices and will be configured based on the defined blueprint requirements.
Once configured, the solution is demonstrated in a conference room setting. Following pre-defined test scripts, different
roles in the process are executed by the appropriate Repligen team members.
 Upon completion, gaps / issues are identified / addressed and Repligen team lead(s) sign-off.

• Baseline Configuration • Design Framework Complete • Complete Configuration


• BPP’s / Test Scripts • Most RICEF Specs Complete • Complete Development
• Sprint Use Cases • Configuration almost complete • Complete BPPs / Test Scripts
• Initial Design Framework • BPPs / Test Scripts • Client Knowledge Transfer
• RICEF Development Specs • RICEF Development WIP • Security Auth. Testing
• Client Knowledge Transfer • Client Knowledge Transfer • MD Load Target: 90%
• Initial Security Auth. Review • Security Auth. Testing • Plan / Prep for Training
• MD Load Target: 20% • MD Load Target: 60% • Validation: Test Script Updates
• Validation: URFS • Validation: Test Script Id / Updates

• Full Solution Integration Test


• Validation Test Script Execution
No new functionality is to be introduced during • Configuration for Fixes Only
• Installation Qualification
• RICEF Dev for Fixes Only
these test cycles. • Operational Qualification
• Update BPPs / Test Scripts
• Production Qualification
A ‘Solution Freeze’ must be in place at the close of • Authorization Testing
• Validation Summary Report
Sprint 3 in order to effectively complete the • Prepare for End User Training
Integration and Validation Test Cycles. • MD Testing
• Validation: Test Script Dry Runs

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Realize Phase
Knowledge Transfer / Solution Ownership

During the project the objective is to evolve from consultant led effort to client
ownership as we move towards Go-Live
Knowledge / Ownership

Repligen

Identify Project Teams Sprint 1 Sprint 4 Int. Testing Validation Support


Basic Navigation Training Sprint 2 Sprint 3 & Training Testing

Answerthink

Time / Project Stage

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Realize Phase
Approach / How we work!

Consultant(s)
Sprints
No
Configuration

AT Repligen Yes

Repligen Process Update Update


Expert(s)
Test Script BPP
Repligen
Requirements Repligen Repligen

Migrate to Good
Quality Test?

25
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Realize Phase
Testing
Prepare Explore Realize Deploy

SBX (Pre-Assembled) DEV DEV/QA QA QA QA/PROD PROD

Project Preparation Business Solution Validation


Sprint 1 Sprint 2 Sprint 3 Sprint 4 Solution Tested Start of Production
Completion Completion

Baseline Build Business Scenario Definition

Test Case Development

Project Testing Test Unit Unit Unit Unit Integration Integration


Testing Assessment
Strategy Plan Testing Testing Testing Testing Testing 2 Testing 2
GMP
Validation
Finalize Testing Data
Data Migration Data Migration Testing
Approach & Data Migration Testing 1 Migration
Test 3 Test 4
Clients Test 2
Project System
Environment
Test Team Mobilization & Validation Testing
Project Milestone / Training Preparation & Dry Runs
Q-Gates
Security Testing
Testing Work Packages

Testing Support Performance Testing


Packages

Validation

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Implementation Methodology
Stage 4 – Deploy / Final Prep (Test, Train, and Cutover)

Purpose Deliverables Milestones & Key Decisions


Prepare System for Production Release  Cut-Over Plan  Organizational Changes Implemented
Prepare the Internal and External Organization  End User Training  Go/No-Go Decision
for Go-Live
 Production Support Plan
 Help Desk
 Technical Support
 Data Converted
 Validation Activities
 Go-No Go Assessment
 Operational Production System Environment

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Implementation Methodology
Stage 5 - Go-Live and Support (Support)

Purpose Deliverables Milestones & Key Decisions


Ensure the Business Owns and Executes New  Live Production Environment  Go-Live
Business Processes and Systems
 Operational Help Desk  Project Close
 Cut-Over and Conversion Activities
Monitor Business Process Results Completed
Monitor Production Environment  Post Go-Live End-User Training (TBD)
Establish
Center of Excellence for Support and  Lessons Learned
Enhancements

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Implementation Methodology
Stage 6 - RunSAP

Purpose Deliverables Milestones & Key Decisions


Run implemented SAP solution  Assessment of Operation Standards for  Identification of Operation Standards for
Optimize
optimize solution operation optimize solution operation
solution operation by implementing
SAP Operation standards  Identify scope  Design, Setup and Operation of SAP
Operations Standards
 Setup project schedule for
implementing

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P = Primary Ownership
Implementation Methodology S = Supporting Role

Summary Major Deliverables and Responsibility

Project Stage Deliverable Repligen ANSR


Initial Project Plan S P
Project Preparation Kick-off Meeting Presentation S P
Project Team Training Plan S P
Installed and Verified Development System S P
Business Blueprint Design Documents S P
RICEF Requirements S P
Validated Project Plan S P
System Landscape and Transport Strategy / Technical Architecture S P
Business Process Master List and BPP Listing S P
Realization Sprint Schedule S P
Sprint Scripts P S
Completed Playback / Unit Test Execution & BPP Development P S
Final Integration Test Plan and Test Cases P S
Completed User Acceptance & Integration Testing P S
User-role and Authorization Concept P S
Configured and Tested Dev, QA, and Production System S P
Final Cut-over Plan S P
End-user Training Plan P S
End User Training Documentation / Training Materials (BPP's) P S

Final Preparation End User Training P S


Production Support Plan P S
Completed Technical System Test P S
Completed System Performance Test P S
Production Ready System P S
Go Live & Support Go-live Support Review P S

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– Project Overview

– EzLifeSciencesTM Overview
Agenda – Approach

– Implementation Methodology

– Validation

– Organization & Staffing

– Next Steps

31
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Validation Overview
Integrated Validation Framework - Arbour Group SAP Compliance Package

 Packaged compliance solution for pharmaceutical, medical device and biotechnology companies
 Complementary to SAP's tools
 Includes "Best Practices Pharmaceutical Industry“ and "High Tech:
– Business, Medical and Consumer OEM"
 Compliance Package certified on Answerthink’s EzLifeScience Solution set
– Over 4 dozen joint successful engagements to date

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– Project Overview

– EzLifeSciencesTM Overview
Agenda – Approach

– Implementation Methodology

– Validation

– Organization & Staffing

– Next Steps

33
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Executive Steering Committee Note:
Organization and Staffing (Names, Names) Repligen:
Internal Resources
Project Governance – Representative Program Sponsor
Answerthink: External Resources
(Name)

Program Management Team


Business Program
IT Program Manager PMO
PMO
Manager (Name)
(Name)
(Name)

SAP Project Manager SAP


SAP Project
Project Manager
Manager
(Name) (Name)
(Name)

Business Process Tracks


Sales / Order Logistics / Service Finance / Human
Planning
Planning Procurement
Procurement Manufacturing
Manufacturing Quality
Quality
Mgmt. Fulfillment Management Controlling Resources

SAP Planning Lead SAP Sales & Dist. Lead SAP Materials Mgt. SAP Logistics Lead SAP Production Lead SAP Quality Lead SAP Service Mgt. Lead SAP Finance Lead SAP HR Lead
Lead SAP Finance #2
Global Design Lead Global Design Lead
Global Design Lead 10-20 % Name Global Design Lead Global Design Lead Global Design Lead Global Design Lead 10-20 % Name Global Design Lead Global Design Lead
10-20 % Name 10-20 % Name 10-20 % Name 10-20 % Name 10-20 % Name 10-20 % Name 10-20 % Name
Track Lead Track Lead
Track Lead 60 – 80% Name Track Lead Track Lead Track Lead Track Lead 60 – 80% Name Track Lead Track Lead
60 – 80% Name 60 – 80% Name 60 – 80% Name 60 – 80% Name 60 – 80% Name 60 – 80% Name 60 – 80% Name

SME: Identified Subject Matter Experts SME:


SME: •10-25% Name SME: SME: SME: SME: •10-25% Name SME: SME:
•10-25% Name •10-25% Name •10-25% Name •10-25% Name •10-25% Name •10-25% Name •10-25% Name •10-25% Name •10-25% Name
•10-25% Name •10-25% Name •10-25% Name •10-25% Name •10-25% Name •10-25% Name •10-25% Name •10-25% Name •10-25% Name
•10-25% Name •10-25% Name •10-25% Name •10-25% Name •10-25% Name •10-25% Name •10-25% Name •10-25% Name •10-25% Name
•10-25% Name •10-25% Name •10-25% Name •10-25% Name •10-25% Name •10-25% Name •10-25% Name

IT
IT Support
Support // Data
Data Management
Management Lead
Lead
Business Unit / Geography Representation (As needed, during Blueprint, Playbacks, Testing, etc.)
Sweden
Sweden Germany
Germany Netherlands
Netherlands APAC
APAC
Site
Site Coordinator
Coordinator Site
Site Coordinator
Coordinator Site
Site Coordinator
Coordinator Regional
Regional Sales Office
Sales Office Coordinator
Coordinator

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Organization and Staffing
Summary Steering Committee Roles and Responsibilities
 The Executive Steering Committee (ESC) sets project priorities, approves scope, and resolves issues in
accordance with the vision and goals set by the Project Sponsors. The Executive Steering Committee aids in
promoting the SAP implementation project throughout the organization. The primary responsibilities of the
Executive Steering Committee members:
– Monitor project budget, scope and schedule
– Commit required resources to the project
– Maintain congruence between Repligen SAP Project and other associated initiatives
– Monitor the Risk Management Plan and Mitigate Risks
– Assess organizational impacts and act as change leaders
– Empower the core project team to make decisions
– Remove barriers to the project
– Resolve escalated issues
– Generate timely decisions, supporting Project Management to accomplish the project goals
– Sign-off of phase milestones
– Recommend whether or not the system should go live.

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Organization and Staffing
Summary Project Management Roles and Responsibilities
 The Project Managers (PM) own the project deliverables and are responsible for day-to-day project management. The
Project Managers are the primary liaison with the Steering Committee.

 The PM responsibilities will be shared between the Repligen PM and the Answerthink PM, and will include:
– Definition of the implementation strategy
– Preparation and maintenance of the project plan, project budget, work plan, and project charter
– Supervision of project activities and production of all deliverables
– Acquisition, assignment and ongoing management of project resources
– Communication of project status to the Executive Steering Committee, Project Sponsors, and the Project Team
– Resolve/escalate project issues

 The PM must proactively anticipate project deviations and be responsible for taking immediate corrective action. It is also
the PM’s responsibility to obtain an understanding of the overall SAP business process integration in the Repligen
environment – the PM must be able to participate in the blueprinting of Repligen’s business processes.

 The PM participates in the Executive Steering Committee and Sponsors Meetings. In addition, the PM participates as an
active member of the Change Management Team.

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Organization and Staffing
Summary Repligen Team Key Roles and Responsibilities

 Work with Answerthink to develop, design and  Active participation in Sprint sessions
approve business processes (Blueprinting &
Realization) – Defining and writing playback scripts

 Perform Master and Transactional data cleansing, – “Driving” by Sprint 1 (some areas), Playback 2 (most
areas)
mapping and conversion

 Adapt (re-write as necessary) the BPPs and Test  Lead Integration & User Acceptance Testing
Scripts for Repligen’s requirements; prepare other – Test script definition and development
training materials as required
– Implementation
 Primary recipient of Consultant Knowledge
Transfer – Approval of system

 Perform end-user training

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Organization and Staffing
Summary Answerthink Consultant Roles and Responsibilities

 Partnership  Define Structure of Testing Scripts, Scenarios and


Data Requirements
 Provide Business Best Practice and SAP Content
Expertise  Define Structure of End-User Training Documents

 Develop Business Blueprint Document  Support for Testing and Validation

 Configuration of SAP Functional and Technical  Support User Acceptance Testing


Development Requirements
 Support End-User Training
 Knowledge Transfer to Team Leads
 Support System Post “Go Live”
 Define Master Data Structures for Data Cleansing
and Conversion

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– Project Overview

– EzLifeSciencesTM Overview
Agenda – Approach

– Implementation Methodology

– Validation

– Organization & Staffing

– Next Steps

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© 2018 The Hackett Group, Inc. All rights reserved. Reproduction of this document or any portion thereof without prior written consent is prohibited.
Contact Information

Michael Greene
Principal, SAP Delivery Services
mgreene@answerthink.com
570.466.5155

Robert Kaplan
Senior Director, SAP Delivery Services
rkaplan@answerthink.com
781.507.5182

Amsterdam | Atlanta | Chicago | Frankfurt | Hyderabad | London | Miami


Montevideo | New York | Paris | Philadelphia | San Francisco | Sydney | Vancouver

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© 2018 The Hackett Group, Inc. All rights reserved. Reproduction of this document or any portion thereof without prior written consent is prohibited.
www.thehackettgroup.com

Statement of Confidentiality and Usage Restrictions


This document contains trade secrets and information that is sensitive, proprietary, and confidential to The Hackett Group the disclosure of which would provide a competitive advantage
to others. As a result, the information contained herein, including, information relating  to The Hackett Group’s data, equipment, apparatus, programs, software, security keys,
specifications, drawings, business information, pricing, tools, taxonomy, questionnaires, deliverables, including without limitation any benchmark reports, and the data and calculations
contained therein, may not be duplicated or otherwise distributed without The Hackett Group Inc.’s express written approval.  
EzLifeSciences™ Overview
Built from 40+ years of deep industry experience and now on S/4 HANA
 Leveraging our deep SAP knowledge and extensive industry experience,
Answerthink has developed EzLifeSciences™. An SAP certified All-in-One
solution for growing biotech, medical device and pharmaceutical companies. EzLifeSciences ™
– EzBio
– EzMedDevice
– EzPharma
– EzServiceProvider

 EzLifeSciences™ leverages SAP’s rich functionality and best practices in support


of the Life Sciences industry focused on deploying the following advantages:
– Provide better visibility into operations through the ability to monitor, manage, and
analyze integrated information from across the enterprise.
– Reduce compliance risk through proven GXP, 21CFR Part 11, audit trail, and EBR
compliance technology, the ability to apply electronic signatures at all levels, and ease
of validation.
– Achieve lower total cost of ownership through proven implementation methodologies in
validated environments; fewer costly and complex interfaces; the use of an open,
cross-enterprise application and integration platform; and simplified maintenance.
Industry Expertise
Experienced Organization

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