We have many years of experience working with a wide range of life sciences clients, including pharmaceutical companies, medical device manufacturers, biotechnology companies, and healthcare providers.
As a result, we have a deep understanding of the unique challenges and opportunities facing life sciences companies and can create tangible value for our clients based on our expertise and experience in the industry.
LIFE SCIENCES
Transfer of processes and functions under consideration of a TSA timeline
CLIENT
The customer is a full-service company with more than 50 years of experience in developing, manufacturing, and registration of biopharmaceutical products according to international standards such as EMA or FDA.
Main project goals
rollout of existing SAP processes and functions to the newly acquired US site
hard deadline based on a transitional service agreement (TSA)
replacing multiple legacy systems (JDEdwards – ERP, Levante – Vendor Management, …) and reusing/adjusting existing validation documentation
migration of relevant master and transaction data
Solution
Based on actual SAP system processes in the US and Germany, respectively, fit/gap workshops were conducted. Gaps were documented and evaluated.
Existing validation documentation was analyzed, translated, and adapted. Existing SAP functions were translated, transferred to the US site, and adapted based on legal or business-critical requirements.
In less than seven months between kickoff and go-live, the project team was able to integrate the new site into the existing SAP system (incl. data migration and end-user trainings)
Key advantages
timely replacement of legacy systems in compliance with TSA requirements at no additional cost
ensuring business continuity during the transition period from legacy systems to SAP
creating a common baseline for harmonized and standardized processes and master data across sites
Input and contribution of CNT
overall project responsibility
analysis, design, and implementation of processes in SAP FI/CO & PS, MM/OM, SD, WM, PP and QM
analysis and adaption of existing developments; implementation of two new interfaces
authorization analysis and transfer of role concepts to the US
implementation of the ERP template
test, training, and cutover management as well as end-user trainings
coordination, adjustment, and transfer of validation documentation
data migration based on global validation and verification guidelines
LIFE SCIENCES
Template Rollout With Localizations
CLIENT
The client is a research-driven company dedicated to the research, manufacturing, and distribution of pharmaceuticals that improve health and quality of life.
Main project goals
global template rollout for the client’s US branch
design, implementation, and validation of all additional, legal or business-critical requirements
ensuring business continuity from day one of the go-live
Project Scope
analyzing the current IT and process landscape
conducting fit-to-standard workshops to define additional local requirements in relation to existing process templates
design, implementation, and validation of all new and additional requirements
testing data migration multiple times to ensure high data quality
handling all technical and business-relevant transition activities
go-live followed by six weeks of intensive support
Important advantages
integration of the US branch into the global SAP process template
implementation of all critical additional requirements
ensuring high data quality during migration
supporting the organization through change management to promote business readiness for the go-live
Input and contribution of CNT
implementation partner
project management
system architecture and application architecture design, including the connection of local systems
design and implementation of all additional template requirements and interfaces
overall coordination of the cutover phase
managing all external partners, such as customers and suppliers
monitoring test planning and test execution
LIFE SCIENCES
Template/Rollout and S/4HANA preparation
CLIENT
The client is a global biopharmaceutical company focused on creating value for people living with severe diseases in immunology and neurology.
Main project goals
creation of a global ERP template to replace legacy systems
compliance with legal and tax requirements as well as GxP requirements
S/4 pre-study to identify impacts and business benefits
definition of a digital roadmap (S/4HANA)
Solution: ERP template
CNT hired Advisum, whose consultants handled our client’s global ERP template and rollouts.
creation of an ERP template for all global operations
implementation of template functionalities
GxP compliance
integration with the MES and LIMS system
supply chain integration (3PL, CMO)
overseas plants and in-house process implementation
advanced planning
business intelligence
installation of the Advisum Data Quality Monitor to evaluate and improve the quality of master data
Important advantages
standardization and globalization of processes
state-of-the-art ERP solution as a basis for rapid business growth
increased efficiency
supply chain optimization
Input and contribution of CNT
project management (global)
senior consulting with various process teams
leading the integration management
template definition / implementation / support
optimization of the business process
logistics and manufacturing know-how
data migration
LIFE SCIENCES
S/4HANA Conversion
CLIENT
The client is a research-driven company dedicated to the research, manufacturing, and distribution of pharmaceuticals that improve health and quality of life.
Main project goals
conversion of the global GBS system from ECC to S/4HANA, taking into account validation-relevant testing and documentation requirements
system conversion in a global “big bang”
basis for future innovations and further rollouts
Solution: ERP template
proof of concept to ensure technical feasibility and as a basis for implementation planning
first phase (“make it work”): initial technical conversion and testing of the central template processes, followed by a system freeze of the operational R/3 system
second phase (“validate and convert”): focus on country-specific localizations that are used in the worldwide rollouts, the validation of all critical functions and the preparation for the go-live
productive conversion (big bang): conversion of the entire system within four days (approx. 70 company codes in 40 countries incl. 400 surrounding systems and 900 interfaces)
Important advantages
continued use of already existing global template processes
minimization of system freeze and dual maintenance
marginal impact on ongoing operations
early conversion of the entire system to a sustainable innovation platform
Input and contribution of CNT
end-to-end responsibility for the entire project
technical system conversion (incl. automated “code conversion”)
coordination of global testing and validation activities
This is the largest project of its kind in the German-speaking world – a lighthouse project whose complexity is based not only on the size of the organization, but in particular on the specific requirements of a “validated” system in the pharmaceutical industry (detailed specification and documentation of business requirements, technical design, development, and test plans/results in a detailed, quality-assured system).
LIFE SCIENCES
Global ERP tempate, process harmonization, deployment
CLIENT
Our client is a biotech company with differentiated medicines for oncology, immunology, infectious diseases, ophthalmology, and diseases of the central nervous system. A pioneer in diabetes management, the company is also a leading provider of in-vitro diagnostics and tissue-based cancer tests. Our client is active in over 100 countries.
Main project goals
creation of a global ERP template for the diagnostics division
replacement of three individual SAP systems as well as different ERP systems
standardized rollout and implementation approach
linking all processes and locations on a global level
Solution
A globally harmonized template was created that meets the logistical and financial requirements of all diagnostics sites while complying with group-wide specifications.
Among others, PLM7, TM, GTS, and MDG were implemented in or connected to the new ECC system based on a HANA database.
In a total of three rollout phases, ~15,000 users at ten sites around the world have now been added to the system.
Important advantages
harmonized and standardized processes and master data
increased governance and efficiency in the areas of SOD, master data, and change management
cost reduction by replacing different systems
Input and contribution of CNT
contributing to the template processes
implementation of the ERP template
support in the harmonization of business processes
support for global rollouts
data harmonization and cleansing
data transfer using global validation specifications
development of the methodology and guidelines for the rollout of the ERP template
LIFE SCIENCES
Global ERP template
CLIENT
Our client is a leading global provider of breastfeeding products (breast pumps) and medical vacuum technology.
Main project goals
analysis, optimization, and documentation of existing business processes
functional and technical documentation of business processes
step-by-step creation of a global ERP template based on SAP ERP ECC 6.0, starting with the template for the USA
Solution
The global processes were developed with a focus on FI-CO, SD, Logistics WM, Purchasing MM (indirect purchasing), and Master Data Management.
This was implemented in five phases:
scope definition and program set-up (“prepare” phase)
definition & description of the process template (design)
development of the IT solution (“realization”)
test phase (“go-live preparation”)
implementation (“cut-over and go-live”)
Important advantages
swift start in design & implementation through CNT best practice reference approach
implementation of regulatory requirements (US-FDA, EU) through proven and process-oriented validation approach
global versus local project team for optimized know-how transfer
risk-minimized commissioning in two phases in the USA, followed by the start of rollouts
Input and contribution of CNT
significant control in project, process and quality management
local US team of senior CNT consultants on site (Chicago)
global team (Europe) for coordination & to ensure global focus
best practice input from CNT consultants as basis for process definitions + project and quality management
optimization of business processes
template definition and implementation
system validation and set-up of test systems (SolMan 7.2)
LIFE SCIENCES
Global template and deployment
CLIENT
The client is a research-driven company dedicated to the research, manufacturing, and distribution of pharmaceuticals that improve health and quality of life.
Main project goals
creation of a global ERP template
standardized rollout and implementation approach
full compliance with legal and tax requirements as well as GxP requirements
Solution
Our client decided to implement a global ERP solution for all commercial and operational departments based on the SAP solutions ERP, SRM, MDM, and BW. The project team consisted of domain experts, internal and external IS members and a CSV&C team. The complete template development was implemented based on the best practice pharma process model by CNT Management Consulting GmbH.
Success factors during the creation of the ERP template and during the rollout projects were the global template steering team, which was in close contact with the IS members and domain experts.
The implementation of the template functionalities was supported by a “CNT” offshore team in India.
Important advantages
process acceleration through the integration of core processes from sales order creation and production all the way to delivery
increased efficiency in production planning
shares service model incl. implementation
Input and Contribution of CNT
project management (global)
senior consulting with eight process teams
Computer System Validation & Compliance (CSV&C) – management and delivery
head of integration management and handover for business and IS
template definition / implementation / support
optimization of the business process based on the pharma reference model
coordination of nearshore and offshore developments
LIFE SCIENCES
Global ERP deployment program
CLIENT
The Germany-based client is a global leader in generic pharmaceuticals and biosimilars.
Main project goals
implementation of harmonized processes to facilitate integrated supply chain, production, commercial and finance processes
Solution
The client chose a single client setup based on a global template. This template was rolled out to all trading and manufacturing locations worldwide. The template included all functional areas and interfaces to all business-critical applications.
Important advantages
supply chain
A significant amount of the projected benefits of the new supply chain model defined by GLOBE depend on implementation of a new, harmonized ERP system:
reduction in net working capital through lower inventory levels
savings in supply chain costs
reduction of inventory depreciation
simplified management of complex supply chain
basis for automated, flexible supply chain KPI reporting with reduced effort
Input and Contribution of CNT
CNT supported the template build as well as various deployments with an experienced consultant team in all areas.
Besides the deployment support, CNT had a a key governance team to support the execution and quality of the deployments.
LIFE SCIENCES AND MEDICAL TECHNOLOGY
SAP Ariba Rollout
CLIENT
The client is a research-driven company dedicated to the research, manufacturing and distribution of pharmaceuticals that improve health and quality of life.
Main project goals
rollout of the global SAP Ariba template to the following countries: United Kingdom, Ireland, Mexico, Puerto Rico, and Spain
replacement of existing legacy systems (e.g., SAP SRM)
change management at the affected sites and ensuring a one-to-one implementation of the template
enforcement of global guidelines (keyword governance) at the locations
Solution
application of a standardized rollout methodology
local team leadership as responsible project managers for successful implementation at the affected locations
digital-only procurement process via Ariba network
stringent process management and project governance
close cooperation with global functions
Important benefits
consolidation of all procurement processes on a central platform
preparation of purchasing processes for the conversion of the ERP system to SAP S/4 HANA
enforcement of sourcing and procurement guidelines at all locations
digitization and standardization of procurement channels
more intensive use of global and local supplier catalogs
Input and Contribution of CNT
experienced SAP Ariba consulting team
experienced rollout team
team leadership and project management
coordination of the involved teams (global template team, local rollout team, SAP Ariba)