SAP Forum 2014 - Presentation Tiger Project @ Geistlich Pharma AG_

Lean and validated ERP implementation at
Geistlich Pharma
Dr. Renzo Salzmann
Geistlich Pharma AG
Daniel Kuhn
Swisscom IT Services AG
SAP Forum Basel
May 20, 2014
Agenda
1
Introduction
2
Project Requirements
3
Challenges
4
Project Approach
5
Key Success Factors
6
Conclusion
7
Benefits
SAP Forum 2014 - Geistlich Pharma AG
Agenda
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2
1. Introduction
Who is Geistlich Pharma?
• World market leader in regenerative dentistry
• International leader in biological bone, cartilage and soft tissue regeneration (dental
and orthopedics)
• Global player with eight subsidiaries and a distribution
network in more than 50 countries
• Producer and supplier of pharmaceuticals
and medical devices.
• 450 employees, 250 in Switzerland
• Located in Wolhusen & Root (LU)
• Family owned
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Company Overview
3
SAP Forum 2014 - Geistlich Pharma AG
Who is Geistlich Pharma AG?
1. Introduction
Company Overview
SAP Forum 2014 - Geistlich Pharma AG
Global presence and distribution network
4
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Geistlich Pharma as a global Player
•
•
•
Headquarters
Subsidiary
Distributor
1. Introduction
• Treatment with Geistlich Bio-Oss® and Geistlich Bio-Gide®
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Company Overview
5
SAP Forum 2014 - Geistlich Pharma AG
Dental indication
1. Introduction
Company Overview
SAP Forum 2014 - Geistlich Pharma AG
• Orthoss® – ideally suited for bone regeneration
6
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Orthopedic indication
1
prosthesis revisions (e.g. hip and knee)
2
in treatment of benign tumors and bone cysts
3
absence of healing of a fracture or osteotomy
4
fusion of the spinal column
5
ideal carrier material for bone marrow cell concentrate
Everything under one roof
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Marketing & Sales
Distribution
Geistlich Pharma as a global Player
SAP Forum 2014 - Geistlich Pharma AG
R&D
Production
1. Introduction
7
2. Project Requirements
Why a new ERP system?
• Old legacy systems no longer supported, no interfaces to crucial systems (e.g. LIMS)
• No efficient handling of increasing complexity (products, markets)
• Lack of transparency and real-time data
• Computer System Validation (CSV) issue
Conclusion:
• Starting Project Tiger (Targeted Implementation of Geistlich Enterprise Resources)
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Project Requirements
8
SAP Forum 2014 - Geistlich Pharma AG
What lead to the Tiger Project?
2. Project Requirements
What needs to be achieved
• Implementation of a fully integrated SAP ERP System
• Using SAP Best Practices for Chemicals as a standard
• Interfaces to all critical sub-systems
• Full conformity with all compliance requirements (EU, FDA)
• Scalable system to support future growth and competitiveness
• Enhance grade of automation and highest possible efficiency in handling transactions
• Targeted implementation within a very short time and within budget - severe
restrictions in Change requests and strict cost controlling
• Build Up an early SAP Competence Center to establish internal project and operation
support
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Objectives
9
SAP Forum 2014 - Geistlich Pharma AG
Goals to be achieved?
2. Project Requirements
Scope
• Project scope:
SAP ERP, SAP Solution Manager, SAP GRC, OpenText Archive
• Process coverage:
Production and Planning, Purchasing, Warehouse Management,
Sales & Distribution, Quality Management, Finance, Controlling,
HR, Workflow for Purchase Orders and Invoices, Mobile Scanning
Devices and several Interfaces
• Rollout scope:
Switzerland (the implemented processes are designed for later
international rollouts to Geistlich Pharma AG subsidiaries)
• Method:
SAP Best Practices for Chemicals, SITS Project Methodology,
Validation Guidelines ISPE GAMP5 (V-Model), SAP Solution
Manager, ASAP Roadmap
• Implementation
partner:
Swisscom IT Services AG (SITS)
SAP Forum 2014 - Geistlich Pharma AG
Scope
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2. Project Requirements
Scope
• Project duration:
10 months
• Go-live date(s):
01-July-2013
• # of users
implemented:
120
• Additional users
planned:
40 (for international rollout)
• Project effort:
3’500 person days
SAP Forum 2014 - Geistlich Pharma AG
Scope
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11
3. Challenges
Major project challenges
• Fulfilling CSV (Computer System Validation) requirements by:
• engaging SAP DE CSV experts to bring in a CSV Best Practices method
• use of SAP Solution Manager as DMS for the complete process and system
documentation incl. electronic sign-off procedures (e-signature) and progress
control.
• Short implementation timeframe by:
• using best business experts as well as best external consultants and have
dedicated times they can work for this project.
• proper project management, controlling and risk management.
SAP Forum 2014 - Geistlich Pharma AG
Challenges
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12
3. Challenges
• Managing project complexity and various partners, implementing different SAP
systems, interfacing external systems and approval workflow by:
• Swisscom project manager as SPOC for communication, resource availability.
• Project management enforcing project governance to all involved parties and
resources.
SAP Forum 2014 - Geistlich Pharma AG
Challenges
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13
3. Challenges
Clearly a big challenge…
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Put the tiger in your tank
14
SAP Forum 2014 - Geistlich Pharma AG
Put the Tiger in your tank
3. Challenges
Key question
Is a lean and validated SAP ERP implementation
in a pharmaceutical SME possible?
Swisscom/Geistlich Pharma Reference Film
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Key question
15
SAP Forum 2014 - Geistlich Pharma AG
Key question
4. Project Approach
In the following we are going to prove that it is possible if…
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Proof the key question
16
SAP Forum 2014 - Geistlich Pharma AG
How to proof the key question…
4. Project Approach
Timeline, Organization, Scope, Method
Project Approach
MS100
Timeline
MS80
Create & Review URS, FS, DS
Create & Review TS &
Templates
RA
Data Migration Plan
Go-live & Support
Stabilization
MS110
MS130
Create Validation
IQ, OQ & PQ
Report
MS70
Design Operations
Handover to
Setup Operations
Operation & Optimization
Operations
Team Swisscom
MS50
Project Preparation
Final
MS90
Create Validation Plan &
MS140
Preparation
Change Management
Project Management / Integration Management
04/12
05/12
06/12
07/12
08/12
09/12
10/12
11/12
12/12
01/13
02/13
03/13
04/13
05/13
06/13
07/13
08/13
09/13
GEISTLICH
Swisscom
Go-live
Realization Phase
MS40
MS120
Project Management
Rapid Decision Board
10/13
i2S
Sub-project
Finance
GEISTLICH
Swisscom
GEISTLICH
Organization
Sub-project
Sales & Distribution
Sub-project
Production
Sub-project
Materials Mgt.,
Procurement, WM
FICO
VERK
EINK

Enterprise M anagement & Support / Finanzen & Controlling

Sales & M arketing / Verkauf

Supplier Collaboration / Einkauf
YES
EINK_002
Procurement Contract / Kontrakte
YES
EINK_003
Consumable Purchasing / Beschaffung nicht lagerhaltige
YES
EINK_004
Artikel (Verbrauchsmaterial)
Scope
In Scope
NO
In Scope
YES
In Scope
YES
In Scope
NO
MM
In Scope
YES
MM
In Scope
YES
MM
Out of Scope
Yes
In Scope
No
Procurement without QM / Beschaffung ohne QM
FI Consultant
CO Consultant
SD Consultant
PP-PI Consultant
MM/WM
Consultant
Sub-project Validation
Integrationsmanagement
RICEF, SAP Infrastrukture and SAP Basis Services
SAP Baseline
Szenario /
133
129
130
Procurement of batch managed stock materials / Beschaffung
chargenpflichtiger Lagermaterialien
Procurement of warehouse managed stock materials /
Beschaffung WM -verwalteter Lagermaterialien
NO
EINK_007
Procurement of pipeline materials
TBD
EINK_008
Procurement of external Services
903
904
YES
EINK_012
Rebate Agreements / Lieferantenrückvergütung
In Scope
NO
YES
EINK_100
M aster Data / Stammdaten
In Scope
YES
YES
EINK_200
Reports / Berichte
In Scope
NO
Supply Chain Planning & Execution / M aterialwirtschaft
In Scope
YES
In Scope
YES
Out of Scope
YES
M AWI

PROD

M anufacturing / Produktion
ENTW

Innovation M anagement / Produktentwicklung
QUAL

Quality M anagement & Compliance / QM
In Scope
YES
PERS

Human Capital M anagement / Personalwesen
In Scope
NO
INST

Plant M aintenance / Instandhaltung
Out of Scope
YES
MM
Sub-project
HRM
QM Consultant
HR Consultant
Sub-project Validation
SAP Baseline Scenario
SAP ERP Module
SAP ERP Modul /
GMPx relevant?
Scope Definition
Prozess Name / Process Name
Sub-project
QM
RICEF, SAP CC, SAP Infrastructure and SAP Basis Services
Prozessliste / Process List
ifax Zahlungsbedingungen
GEISTLICH
Change Management
Swisscom
Sub-project
Controlling
Quality Assurance
Swisscom
Method
SAP Forum 2014 - Geistlich Pharma AG
Blueprint & Prototype
Team Geistlich Pharma
FIT/ GAP Analysis,
Training
GEISTLICH
PHASEI
Kick-off
Sign-off
Project Preparation
Steering Committee
MS10: Cont ract sign.off
MS20: End of project preparat ion phase
MS30: SAP basic t raining complet ed
MS40: Validat ion plan and t emplat es approved
MS50: SolMan set up incl. BPML, BP document s and t emplat es
MS60: FIT/ GAP Analysis, Blueprint , Prot ot ype approved
MS70: Final Blueprint in SolMan
MS80: Sign-off URS, FS, DS and RA
MS90: Sign-off TS and Dat a Migrat ion Plan
MS100: SAP ERP syst em configured and t est ed
MS110: IQ, OQ & PQ successfully complet ed & signe-off
MS120: Go-live @ Geist lich Pharma AG, Swit zerland
MS130: Sign-off Validat ion Report
MS140: Project Closure
MS60
PHASEII
Contract
MS30
Validation
MS20
SolMan
MS10
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4. Project Approach
Timeline, Organization, Scope, Method
Project Approach
MS100
Timeline
MS80
Create & Review URS, FS, DS
Create & Review TS &
Templates
RA
Data Migration Plan
Go-live & Support
Stabilization
MS110
MS130
Create Validation
IQ, OQ & PQ
Report
MS70
Design Operations
Handover to
Setup Operations
Operation & Optimization
Operations
Team Swisscom
MS50
Project Preparation
Final
MS90
Create Validation Plan &
MS140
Preparation
Change Management
Project Management / Integration Management
04/12
05/12
06/12
07/12
08/12
09/12
10/12
11/12
12/12
01/13
02/13
03/13
04/13
05/13
06/13
07/13
08/13
09/13
GEISTLICH
Swisscom
Go-live
Realization Phase
MS40
MS120
Project Management
Rapid Decision Board
10/13
i2S
Sub-project
Finance
GEISTLICH
Swisscom
GEISTLICH
Organization
Sub-project
Sales & Distribution
Sub-project
Production
Sub-project
Materials Mgt.,
Procurement, WM
FICO
VERK
EINK

Enterprise M anagement & Support / Finanzen & Controlling

Sales & M arketing / Verkauf

Supplier Collaboration / Einkauf
YES
EINK_002
Procurement Contract / Kontrakte
YES
EINK_003
Consumable Purchasing / Beschaffung nicht lagerhaltige
YES
EINK_004
Artikel (Verbrauchsmaterial)
Scope
In Scope
NO
In Scope
YES
In Scope
YES
In Scope
NO
MM
In Scope
YES
MM
In Scope
YES
MM
Out of Scope
Yes
In Scope
No
Procurement without QM / Beschaffung ohne QM
FI Consultant
CO Consultant
SD Consultant
PP-PI Consultant
MM/WM
Consultant
Sub-project Validation
Integrationsmanagement
RICEF, SAP Infrastrukture and SAP Basis Services
SAP Baseline
Szenario /
133
129
130
Procurement of batch managed stock materials / Beschaffung
chargenpflichtiger Lagermaterialien
Procurement of warehouse managed stock materials /
Beschaffung WM -verwalteter Lagermaterialien
NO
EINK_007
Procurement of pipeline materials
TBD
EINK_008
Procurement of external Services
903
904
YES
EINK_012
Rebate Agreements / Lieferantenrückvergütung
In Scope
NO
YES
EINK_100
M aster Data / Stammdaten
In Scope
YES
YES
EINK_200
Reports / Berichte
In Scope
NO
Supply Chain Planning & Execution / M aterialwirtschaft
In Scope
YES
In Scope
YES
Out of Scope
YES
M AWI

PROD

M anufacturing / Produktion
ENTW

Innovation M anagement / Produktentwicklung
QUAL

Quality M anagement & Compliance / QM
In Scope
YES
PERS

Human Capital M anagement / Personalwesen
In Scope
NO
INST

Plant M aintenance / Instandhaltung
Out of Scope
YES
MM
Sub-project
HRM
QM Consultant
HR Consultant
Sub-project Validation
SAP Baseline Scenario
SAP ERP Module
SAP ERP Modul /
GMPx relevant?
Scope Definition
Prozess Name / Process Name
Sub-project
QM
RICEF, SAP CC, SAP Infrastructure and SAP Basis Services
Prozessliste / Process List
ifax Zahlungsbedingungen
GEISTLICH
Change Management
Swisscom
Sub-project
Controlling
Quality Assurance
Swisscom
Method
SAP Forum 2014 - Geistlich Pharma AG
Blueprint & Prototype
Team Geistlich Pharma
FIT/ GAP Analysis,
Training
GEISTLICH
PHASEI
Kick-off
Sign-off
Project Preparation
Steering Committee
MS10: Cont ract sign.off
MS20: End of project preparat ion phase
MS30: SAP basic t raining complet ed
MS40: Validat ion plan and t emplat es approved
MS50: SolMan set up incl. BPML, BP document s and t emplat es
MS60: FIT/ GAP Analysis, Blueprint , Prot ot ype approved
MS70: Final Blueprint in SolMan
MS80: Sign-off URS, FS, DS and RA
MS90: Sign-off TS and Dat a Migrat ion Plan
MS100: SAP ERP syst em configured and t est ed
MS110: IQ, OQ & PQ successfully complet ed & signe-off
MS120: Go-live @ Geist lich Pharma AG, Swit zerland
MS130: Sign-off Validat ion Report
MS140: Project Closure
MS60
PHASEII
Contract
MS30
Validation
MS20
SolMan
MS10
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4. Project Approach
Systems
Project
Blueprint & Realization
Final
Preparation Prototype
Preparation
SAP
Solution
Manager
CSV of
SolMan
SAP
ERP
Training
Project
Team
SAP
GRC
(e-signature)
Go-live &
Support
DMS for
Blueprint
DMS for
Development
& Testing
DMS for
Data
Migration
Incident
Management
Build
Prototype
Customizing
Development
Testing
Data
Migration &
Enduser
Training
Go-live &
Bug-fixing
GRC
Evaluation
Setup
Access
Control
Go.-live
Access
Control
Constant
use of
GRC
SAP Forum 2014 - Geistlich Pharma AG
Systems
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19
4. Project Approach
Systems Overview
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20
System Overview
SAP Solution Manager
presento.pro
KABA
Faxserver / Mailserver
SAP SolMan
LIMS
FI/CO
SAP GRC
as central system access and
authorization mangement system
MM/WM
Various Interfaces
CRM (MS Dynamics)
PP/QM
SD
Barcode
Scanner
HR/WF
SAP ERP
e-Trans (DHL)
SAP GRC
OpenText
Document
Scanner
SAP Forum 2014 - Geistlich Pharma AG
Time & attendance data
as Document Management System (DMS)
for process & systems documents
4. Project Approach
Systems Overview
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21
System Overview
SAP Solution Manager
presento.pro
KABA
Incident/Change
Faxserver / Mailserver
SAP SolMan
Solution/Change
LIMS
CRM (MS Dynamics)
FI/CO
SAP GRC
as central system access and
authorization mangement system
MM/WM
PP/QM
SD
Barcode
Scanner
HR/WF
SAP ERP
e-Trans (DHL)
SAP GRC
OpenText
Document
Scanner
SAP Forum 2014 - Geistlich Pharma AG
Time & attendance data
as Document Management System (DMS)
for process & systems documents
4. Project Approach
Systems Overview
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22
System Overview
SAP Solution Manager
presento.pro
KABA
Faxserver / Mailserver
SAP SolMan
LIMS
Authorization
CRM (MS Dynamics)
FI/CO
SAP GRC
MM/WM
as central system access and
authorization mangement system
Authorization
Request
PP/QM
SD
Barcode
Scanner
HR/WF
SAP ERP
e-Trans (DHL)
SAP GRC
OpenText
Document
Scanner
SAP Forum 2014 - Geistlich Pharma AG
Time & attendance data
as Document Management System (DMS)
for process & systems documents
5. Key Success Factors
• Clearly defined scope in terms of business processes as well as interfaces and
developments (BPML, RICEF list)
• Process driven (based on BPML) requirement definitions, system configuration
(customizing), developments, documentation, testing and training
• Business team  project manager  sub-project leader  key user
 best people for best results
• Business priorities have been adjusted to focus on the Tiger project as a major
business initiative of the organization
• Project governance (project handbook) set into place (timeline, escalation,
communication, reporting, controlling, templates, etc.) and communicated to the
entire team (Kick-off)
SAP Forum 2014 - Geistlich Pharma AG
Key Success Factors
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5. Key Success Factors
• Commitment of top management at all times
• Focus on SAP Best Practices scenarios to keep development effort as low as possible
• Build-up SAP CC and use of Incident Management to capture issues during testing
phase, go-live and daily operation thereafter
• Intensive testing cycles (functional testing, authorization tests, end-to-end
integration testing)
• Dedicated project space enabling and integrated project environment with short
decision path
• External coaching and advising  i2s  SAP DE  PWC  SITS QA to review critical
milestones as well as to benchmark, execute a project audit and a Part11 assessment
• High transparency of project risks and fast deployment of risk mitigating actions
approved by the Rapid Decision Board (RDB)
SAP Forum 2014 - Geistlich Pharma AG
Miscellaneous
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6. Conclusion
Is a lean and validated SAP ERP implementation in a pharmaceutical SME possible?
Yes, if the following six (6) requirements are fulfilled:
External consultants with profound SAP, process
understanding and industry experience within a CSV
environment.
Committment to SAP Best Practices kept as strict project
guideline throughout the project to keep developments and
scope creep at minimum level.
Detailed and extensive project preparation to set the right
foundation for the project.
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Conclusion
25
SAP Forum 2014 - Geistlich Pharma AG
The six golden rules
6. Conclusion
It has to be a business-driven project and empowerment at
all levels.
GxP
Assessment
PQ
FS
Risk
Analysis
DQ
Integration &
Acceptance
Testing
Functional
Testing
Unit
Testing
DS
BC-Set
IQ
Technical
Documentation
SAP
Solution
Manager
OQ
Comprehensive documentation of all process definitions,
system settings, developments, testing, data migration and
training activities throughout the entire project lifecycle.
Use of SAP Solution Manager as central process and system
DMS with electronic review and sign-off procedure 
complete controlling of deliverables.
SAP Forum 2014 - Geistlich Pharma AG
Conclusion
URS
26
20.05.2014
The six golden rules
7. Benefits
Time, Quality, Cost
TIME:
• Overall month-end closing time reduced by 30 %
• Vendor invoice approval time reduced by 50 %  100 % cash discounts benefits
• Purchase order approval process time reduced by 50 %
COST:
• Stock reduced by 20 % on SKU
level freeing 20 % storage
capacity avoiding warehouse
expansion (cost savings of
CHF 1.0 Mio)
• Stock value reduction by CHF
1.5 Mio
• Coverage differences at
month-end has been reduced
by 75 % due to accurate
product cost calculation and
cost allocations
TIME
COST
QUALITY
QUALITY:
• Fully validated processes and
systems
• Full traceability
• Product distribution in
compliance with market
registration
• Rigid user authorization
control
• Real stock transparency  no
out of stock situations
• Fully integrated process 
ROFO  S&OP  MRP 
Production  Distribution
SAP Forum 2014 - Geistlich Pharma AG
Conclusion
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7. Benefits
Time, Quality, Cost
CONCLUSION:
Even though Geistlich Pharma AG is using SAP ERP less than one (1) year significant
benefits of the SAP ERP implementation have been realized and further are expected.
Therefore the overall project return on investment will be between 2 - 3 years.
TIME
COST
QUALITY
SAP Forum 2014 - Geistlich Pharma AG
Conclusion
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7. Benefits
Future business benefits planned
• Rollout to subsidiaries in order to fully integrate intercompany processes.
• Rollout to other legal entities
• Planning accuracy by implementing concurrent planning, VMI-process incl. interfaces
to external warehouses.
• BI/BO to support sales and financial controlling and to optimize the sales & operation
processes.
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Outlook
29
SAP Forum 2014 - Geistlich Pharma AG
Outlook
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31
Contact
Geistlich Pharma AG
• Dr. Renzo Salzmann
• Director Technical Operations
• [email protected]
• +41 (79) 709 61 34
Swisscom IT Services AG
• Daniel P. Kuhn
• Senior Project Manager
• [email protected]
• +41 (79) 620 44 74
SAP Forum 2014 - Geistlich Pharma AG
Contact
20.05.2014
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