Success Story Geistlich Pharma AG

Back to the bone:

traceability without any gaps

High demands on quality and

validation
Geistlich has full command over the
entire product chain. From the selection
and evaluation of raw materials, to
research and development, production
and warehousing through to distribu-
tion – all steps are performed in one
smooth process and meet the company's
high requirements in terms of quality
and safety.

To master this complex operation, the

company evaluated a more efficient ERP
system in 2012, one that had to meet
FDA validation requirements. “The central
element for meeting the quality
requirements is clearly the traceability
Dr. Renzo Salzmann, Director Technical Operations Geistlich Pharma AG (left), and Daniel Kuhn, of our products without any gaps,”
Senior Project Manager Swisscom Enterprise Customers
notes Dr. Salzmann. “We must document
processes, release the individual process
steps and keep track of everything elec-
Transparency and traceability without any gaps are of tronically in the system. By doing so, we
decisive importance to Geistlich. Thanks to Swisscom create documented proof of total trace-
ability and reproducibility.”
and SAP ERP, all its processes are FDA-conformant.
High IT requirements
Geistlich Pharma has had a significant impact around the world in Geistlich Pharma's existing ERP system
the market for regenerative biomaterials. The company is the market was stretched to its limits by the increas-
leader in regenerative dentistry and is considered a pioneer in the ing demands in terms of governance/
development of medical products for the restoration of bones, carti- compliance (computer system validation)
lage and soft tissue. Over 450 employees, and more than 50 distribu- and the complexity of the products and
tion partners, plus eight subsidiaries in the UK, Germany, Italy, markets. Transparency and access to
France, China, Brazil, South Korea and North America, market and real-time data were lacking, and also
sell its products around the world. The basis of the company's missing was an interface to key peripheral
growth, innovation and profitability is, in addition to the specialist systems such as the LIMS (Laboratory
expertise, an efficient and scalable IT. With the introduction of SAP Information Management System).
ERP though its implementation partner Swisscom, Geistlich Pharma When support and maintenance were
now has a solution that matches its needs perfectly. then also discontinued, the time was
right for Project TIGER (Targeted Imple-
mentation of Geistlich Enterprise
Resources). The new solution had to
provide full conformance with all com-
pliance requirements (EU, FDA) and, as a
scalable system, support future growth
and competitiveness. An additional goal
at Geistlich Pharma was to improve the
level of automation and maximum effi-
ciency in handling transactions.
 “In Swisscom we have found a
partner that has the expertise
and necessary experience in a
validated environment.”
Dr. Renzo Salzmann, Director Technical Operations, Geistlich Pharma AG

Swisscom and SAP ERP:
the TIGER in the tank
After a detailed evaluation in the search
for a suitable, fully integrated software
solution without any media discontinuity
between the core and support processes,
management decided to implement
SAP ERP. As a standard feature, it se-
lected SAP Best Practices for Chemicals
with a link to all critical peripheral
systems. It also found a very suitable
SAP consulting partner in Swisscom
SAP Services.
TIGER had ambitious goals: a planned
implementation with both a challenging
schedule and clear budget guidelines.
Project directors defined a comprehen-
sive project management structure
with a project handbook (governance
model), which included a project plan
with milestones and which also defined
an escalation path, and contained tem-
plates for communication, reporting
and monitoring. This was established
in the overall project team at the kick-
off. Additional core elements of the
successful project implementation
were the strict limitation of change
requests plus stringent cost controls.
With the immediate set-up of an inter-
nal SAP Competence Centre, it was pos-
sible to establish internal project and
operational support at an early stage.
Suffice it to say that the measures taken
with Swisscom were very effective. The
successful “go live” took place after only
10 months, and everyone is completely
satisfied with the solution. “For us at
Swisscom it was crucial that project
members who had decision-making
authority from all sectors of Geistlich's
operating areas were represented,”
emphasises Project Manager Daniel
Kuhn. “In this way, we were able to
ensure that a solution had been
created for Geistlich Pharma that met
all its business requirements and which
would guarantee a return on invest-
ment in the short term."
End-to-end traceability • CO
Geistlich Pharma manufactures bioma-
terials using its own facilities and with
raw materials procured from around
the world. The company works with the
very latest machinery and equipment,
some of which is developed in-house,
in order to ensure the highest level of
product quality. If somewhere in the
world a health problem arises in a
patient, Geistlich must be able to show
definitively the paths taken by all raw
material batches through the entire
production and supply chain. The regu-
latory requirements in the pharma-
ceuticals industry (e.g. FDA) require CSV
(computer system validation) so that IT
systems and processes are completely
documented and all procedures are
reproducible. Thus, employees work
with hand scanners so that the flow of
materials is systematically traceable. In
this way, it is possible at any time to
determine the location and status of
individual products
SAP ERP guarantees that sales, pro-
curement, logistics and production
processes are all electronically traceable.
Installed modules
Production and logistics:
• SD
• MM
• WM
• PP-PI
• QM
• Workflow
• SAP Archive
Finances:
• FI
Support processes:
• HR
• SAP GRC
• SAP Solution Manager with
e-Signature
Advantages at a glance
• Validated: Documented reproduc-
ibility of all production and busi-
ness processes in the IT systems.
• Digitised: Thanks to CSV (com-
puter system validation), process
steps can be released and ap-
proved directly in the system.
• Compliant: Total compliance
thanks to product traceability
without any gaps (e.g. FDA Part
11).
• Scalable: Future growth can be
accommodated successfully.
• Efficient: With the introduction of
ERP, business and organisational
processes can be optimised and
standardised simultaneously.
• E-archived: Validation documen-
tation is stored electronically in
SAP Solutions Manager.

Swisscom IT Services Ltd

Enterprise Customers
001e – 05/14

Solution Center SAP Services

Pfingstweidstrasse 51
CH-8005 Zurich
www.swisscom.ch/sap