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Life Sciences

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

Kunde  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.

Hauptprojektziele 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

Lösung 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)

Benefits 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 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

Kunde  CLIENT

The client is a research-driven company dedicated to the research, manufacturing, and distribution of pharmaceuticals that improve health and quality of life.

Hauptprojektziele 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

Lösung 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

Benefits 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 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

Kunde  CLIENT

The client is a global biopharmaceutical company focused on creating value for people living with severe diseases in immunology and neurology.

Hauptprojektziele 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)

Lösung 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

Benefits 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 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

Kunde  CLIENT

The client is a research-driven company dedicated to the research, manufacturing, and distribution of pharmaceuticals that improve health and quality of life.

Hauptprojektziele 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

Lösung 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)

Benefits 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 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

Kunde  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.

Hauptprojektziele 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

Lösung 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.

Benefits 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 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

Kunde  CLIENT

Our client is a leading global provider of breastfeeding products (breast pumps) and medical vacuum technology.

Hauptprojektziele 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

Lösung 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:
  1. scope definition and program set-up (“prepare” phase)
  2. definition & description of the process template (design)
  3. development of the IT solution (“realization”)
  4. test phase (“go-live preparation”)
  5. implementation (“cut-over and go-live”)

Benefits 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 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

Kunde  CLIENT

The client is a research-driven company dedicated to the research, manufacturing, and distribution of pharmaceuticals that improve health and quality of life.

Hauptprojektziele 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

Lösung ​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.

Benefits 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 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

Kunde  CLIENT

The Germany-based client is a global leader in generic pharmaceuticals and biosimilars.

Hauptprojektziele Main project goals

  • implementation of harmonized processes to facilitate integrated supply chain, production, commercial and finance processes

Lösung 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.

Benefits 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:
  1. reduction in net working capital through lower inventory levels
  2. savings in supply chain costs
  3. reduction of inventory depreciation
  • simplified management of complex supply chain
  • basis for automated, flexible supply chain KPI reporting with reduced effort

Input 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

Kunde  CLIENT

The client is a research-driven company dedicated to the research, manufacturing and distribution of pharmaceuticals that improve health and quality of life.

Hauptprojektziele 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

Lösung ​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

Benefits 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 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)
  • cut-over management and hypercare