References & Success Stories for Customers & Projects
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Rob Stijlen
Rob Stijlen
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Projects and solutions

Holistic customer orientation, diverse experience, uncompromising readiness to provide quality: It was not by chance that our interdisciplinary teams have been able to help more than 135 life sciences companies to develop perfectly integrated and therefore successful projects and solutions. You can find a selection here!

Areas

Competences

Validierung elektronische Signatur in der Cloud

Electronic Signature in the Cloud

Global introduction of “DocuSign”, a service provider for electronic signature technology. Validation of DocuSign cloud services under consideration of country-specific regulations. Definition of user requirements, risk analysis and risk-based user acceptance testing.

Planisware© 6 Einführung & Rollout

Planisware© 6 Implementation & Rollout

Implementation and global rollout of the portfolio management software Planisware© 6 according to ITIL standards and under consideration of dependencies to other initiatives. Migration of 10.000 projects.
Creation of business, communication and training plans.

Agiles PM für Produktportfolio-Management

Agile PM for Product Portfolio Management

Agile development and implementation of newly defined reporting structure for the portfolio management in R&D in Planisware© 6. Setting up dashboards for project and portfolio management, scenario based reports on business cases and milestone trend analysis. Integration of historical data from the last 10 years.

ARCONDIS Referenzen Pharma

Scale-up of R&D process to commercial production

Transfer and Scale-Up of the R&D process of an innovative biotech-product for commercial production. Definition of a Lean Qualification Strategy, supporting the fast growth of the company. Operational Readiness to deliver in time to clients and mitigate risk of contract penalties.

Serialization and Operational Readiness

Serialization & Operational Readiness

Introduction of serialization and aggregation requirements in the context of a production transfer from a local manufacturing site to a CMO. Ensuring timely Operational Readiness and GxP-conformity of production and packaging to mitigate the risk of stock-outs.

Project Governance Framework & Portfolio Management

Project Governance Framework & Portfolio Management

Evaluation & Implementation of a new software solution for project & portfolio management incl. interfaces to finance and HR systems. Introduction of a new project governance framework and project planning standards to enable corporate portfolio management.

Veeva Vault Software Harmonization & Global Rollout

Veeva Vault Software Harmonization & Rollout

Harmonization of individual configurations of the software solution Veeva (platform for communications processes for life sciences) having regard to necessary country-specific customizations. Definition of Corporate Governance. Global rollout of harmonized solution incl. data migration and user training.

KPI Dashboard in Echtzeit

Real-Time KPI Dashboard

Implementation of SKOOR, a KPI dashboard software, to track the status of all relevant SOPs as well as budget of a simultaneously running project to increase efficiency of IT management services – in real time and from all devices. Concept and definition of software requirements and KPIs.

Data Integrity Assessment Remediation

Data Integrity Assessment and Remediation

Data Integrity assessment on the basis of ready-made sheets, personalized to the customer’s needs. Summary in data integrity readiness report. Remedation of gaps in terms of outstanding qualifications and validations as well as completion of documentation. Upgrading the operation system to ensure data security.

Data Protection Impact Assessment for Hospital

Data Protection Impact Assessment for Hospital

Conduct data protection fitness check to ensure compliance to cantopnal regulations. Analyse & assess application landscape, processes & documentation in respect of protection of personal data. Identify gaps & define recommendations for actions based on risk and urgency.

Validation Medical Device

Validation of a Medical Device

Slim and secure validation of the manufacturing process of a medical device with regard to the injection molding process and the assembly of the disposable parts of the pump. Compilation of documentation of the manufacturing process. Communication between headquarters in Switzerland and the manufacturing site in Turkey.

GDPR Client Encryption – Rollout Management

GDPR Client Encryption – Rollout Management

Rollout management for the technical implementation of global GDPR-compliant Client Encryption. Planning per site taking individual differences into account, determination of validation approach, coordination with technical vendors and on-site experts, creation of training material and coaching, definition of overall governance.

Compatibility Test Services Windows 10 Readiness

Compatibility Test Services Windows 10 Readiness

Proof of concept to ensure critical business applications run on Windows 10. Creation of predefined test steps to asses main functions. Pragmatic and time-efficient combability testing of applications for Windows 10. In-depth testing in coordination with experts if necessary. Reporting on functionality and definition of next steps for updating and re-validation of GxP-relevant applications.

Digitalization: E-Signatures in the Laboratory

Digitalization: E-Signatures in the Laboratory

Definition & implementation of relevant functions for the lab software Empower 3 CDS (chromatography) and Tiamo (titration) according to regulations and best practices to ensure data integrity. Revisioning of the user concept and creation of lean and simplified processes. Validation of new software functions and processes.

GDPR & System Frameworks

GDPR Software Readiness Check

Execution of a Fitness Check related to the new General Data Protection Regulation (GDPR) for a cloud-based customer solution platform. Identification of gaps, definition of a risk-based action plan and presentation of the results within less than one working week.

Service Desk Project

Transition to New Service Desk Provider

Advisory and mediator role for transition to new service desk, analyzing and streamlining existing processes while considering strengths and weaknesses of the new supplier, ensuring that the service desk meets all customerspecific requirements and is also feasible from supplier side, set up of the new governance structure.

Digital Foundation

Digital Foundation - Services

Scoping of digital services in addition to standard Operations IT. Design of the demand management and agile development process, including the definition of a digital service catalogue. Management of an RFP process for the selection of digital service providers.

IDMP

LEAN standardization & IT-supported acceleration of global batch release

Implementation of a global release execution system for batch scheduling, simplification, standardization and acceleration of a global release process by applying LEAN principles.

Einführung eines Shopfloor-Managements zur Ermöglichung der LEAN-Produktion

Implementation of shopfloor management to enable LEAN production

Concept development for a meeting structure, development of a roadmap for the implementation of the new vision and type of corporate governance, fulfillment of the LEAN production requirements.

System Management Framework

System Management Framework

Analysis and setup of system management framework, aligned with the overall strategy. Development of a new governance model as a basis to make value-driven decisions. Creation of an accountability and capability model to leverage resources to the best of their capabilities.

GDPR & Compliance

GDPR Readiness and Compliance

Inventory of all applications and systems regarding usage of personal data, analysis and optimization of processes to ensure data protection and enable risk assessment, global rollout of processes, set up of privacy organization und government, organizational Change Management (OCM) and trainings to raise awareness.

Organizational Harmonization & Implementation of Material Master Solution

Organizational Harmonization & Implementation of Material Master Solution

Agile project management for the creation of a formalized, standardized data governance process and implementation of a material master workflow solution to ensure data integrity and close gaps between the ERP and its interfaces.

Master Data Landscape Evaluation

Master Data Landscape Evaluation

Evaluation and gap analysis of the master data management value chain in comparison to the new SAP solution incl. vendor and customer data assets. SWOT analysis, recommendations and draft template of MDM as a starting point of the new SAP implementation stream.

Securing Data Integrity and Compliance of Manufacturing Data

Securing Data Integrity and Compliance of Manufacturing Data

Analysis and fixing data integrity and compliances gaps in the manufacturing data of ERP and PLM systems as well as in related processes and documents of a medical device company.

Compliance-Gaps

Fixing a Critical Compliance Gap in a MDM System

Fixing a critical compliance gap of a medical device company, which would have resulted in product recalls, within the FDA time frame. Conception and validation of a new master data management system within a new CSV framework.

Migration Application Environment

Migration of an Application Environment

Following the split of a company, a new technical environment had to be created. From an active directory domain to the infrastructure and application environment. This includes the management of the overall project as well as the migration and validation of all GxP-relevant applications.

Portfolio Management

Requirements Analysis for Product Portfolio Management

Requirements assessment and design of the process for selecting the appropriate combinations of components for each research development project based on the Value over Investment (VOI). Proposal of a solution design involving QlikView and Planisware.

GxP-Compliant Supply Chain Software für Medizinprodukte

GxP-Compliant Supply Chain Software for Medical Devices

Global coordination of the validation team during development and implementation of an inhouse-developed supply chain software.

Konfiguration eines globalen IT Qualitätsmanagement Systems

Setup of a Global IT Quality Management System

Set up of a new IT Quality Management System (IT QMS) according to GAMP and ITIL including creation of directives, SOPs, templates and forms.

Due Diligence Investigation

Due Diligence Investigation

Investigation of hospitals, doctors and associations in terms of corruption, money laundering, terrorism and much more for a pharmaceutical corporation.

IDMP Project reference

IDMP Program Support

Program coordination support of the underlying program streams & management of budget, resources and timelines.

Innovative Preismodelle

Innovative Pricing Solutions

Pilot and roll-out of personalized reimbursement models on a national level considering regulations, data privacy and competition laws. Definition of scale-up strategies. Implementation of sustainable infrastructure partnering.

Validation and PMO Support

Validation and PMO Support for EMS Update

Strategic validation consulting in regards to an EMS software update to ensure compliance. Review of validation quality and a completeness check of validation documents. Deeper understanding of data integrity and traceability matrix concepts.

compliance change management

Compliance through Operative Change Management

PQM and PMO for the change management of a portfolio with over 120 change requests. Significant reduction of processing time and total amount of changes across locations. Regulatory compliance through efficient high quality change mangement.

CAPA

Global CAPA Remediation

Improvement of CAPA standards on the basis of newly implemented CAPA processes according to FDA regulations. Creation of deeper understanding for CAPA processes and establishment of KPIs for these processes. Harmonized CAPA system throughout all European sites.

Planisware implementation

Roadmap to Planisware© Implementation

Delivery of a roadmap for Planisware© 6 implementation including a RfI and RfP in order to find an implementation partner. Evaluation of off-the-shelve functionalities to ensure a sustainable, cost-efficient solution. Better strategic decision-making through improved reporting standards.

ARCONDIS news Compliance

Identification of Medicinal Products (IDMP)

Project leadership for the definition of IDMP business processes and the implementation of fit-for-purpose Software to secure compliance to EMA ISO IDMP requirements by 2016. Realization of cost savings through harmonization of product master data.

Implementation of a PQM System

Implementation of a PQM System

Conception of a project quality management system and establishment of quality processes. Conducting Stakeholder training related to quality assurance and new GDP guidelines on a global level. Conducting quality reviews and project gate control.

Complaint management - System implementation

Complaint Management System Implementation

Harmonization of complaint management processes and restoration of IT compliance according to FDA regulations. TrackWise© system validation and introduction of a centralized complaint management system including a desktop and mobile app. PMO and change management process implementation after go live.

Entkopplung Produktionsstätte

IT Infrastructure Unbundling Program for Divestment Initiatives

Resource saving unbundling of the IT infrastructure during a divestment process in several manufacturing sites. Execution of the global program and project management.

Project Management Training

Best Practices Project Management Training for R&D

Design and development of a customised project management training including the implementation of new approaches and methods into running projects. Establishment of a more project-oriented organization.

TrackWise Re-Validation

TrackWise© Re-Validation

Re-Validation of TrackWise© to ensure GxP compliance. Roll-out of the quality managemet system on a global level.

SharePoint Solution

SharePoint© Solution for the optimization of production planning

Development of a SharePoint© platform to capture manufacturing site data on a global level. Enabling the optimization of resource and capacity planning as well as the systematically management reporting.

Data Center Move

PMO for Data Center Move

Project management office for data center outsourcing. Coordination of global teams. Application of best practice project management following PMI standards.

Project Portfolio Management

Upgrade and Enhance PPM-Software Planisware®

Upgrade the Project Portfolio Management System Planisware® from Version 5 to Version 6 including international roll-out. Cost savings in support and maintenance as well as implementation of functional enhancements to cover the requirements of global program management.

IT Services in der Cloud

IT Strategy for globalized Business Model

Design of an agile IT strategy and concept to allow the adaption on the new, globalized Business Model. As-Is analysis, SWOT analysis, realization of quick wins. Recommended action plan and conceptual design of future IT Organization.

Falsified Medicines Prevention Shortview

Prevent falsified medicines

Preventing the release of falsified medicines through rollout of new processes, SOPs and IT systems. Achieving full transparency of the company’s complex supply chain. Establish compliance towards GMP regulations, including EU GMP Annex 16.

GDocP in der Pharma

Batch Certificate Compliance

Mitigation of inspection findings through improvement of existing business processes to meet compliance requirements of EU GMP Annex 16 and EU MRA Batch Certificates. Realization of quick wins in process efficiency. Implementation of an european-wide certificate database.

Projekte

Windows 10 Proof of Concept: VIP Support

Technical support for 600 pilot users, including VIP stakeholders from various business departments. High acceptance through target group-specific support. Evaluation of the Microsoft Service Model and automation of user and release management processes.

Statistische Modellierung im Bereich R&D

Statistical Modelling Capabilities in R&D

Implementation of a centralized, cross-divisional platform providing scalable statistical modelling capacities. Flexible setup allows future use as Cloud Services. Realization of cost savings in licencing, trainings and support.

ARCONDIS Referenzen Pharma

Batch Record Efficiency

Achieving next level of Batch Record efficiency after successful site transfer. Documentation effort reduced by approx. 16%. Identification and resolution of inconsistencies and achieving full coverage of GMP compliance requirements.

Qualifizierung einer Packaging- & Labeling-Anlage

Qualification of a new packaging and labeling line

Lean qualification through in-depth analysis and identification if high risk process steps . Achieving ISO 13485 & GMP Compliance. In-time and smooth commissioning of the packaging and labeling line.

Management-System

GxP-compliant Batch Record Strategy on SAP platform

Regulatory advisory and system validation for the implementation of a GMP-compliant, global authorization concept for batch records on SAP.

Internal audit

Optimized Change Management for Supply Chain Changes

Improved decision making and faster processing of supply chain change requests through streamlined business processes and the implementation of a sharepoint-based Change Management tool.

Internal audit

Customized Project Management Framework

Implementation of globally applied framework for executing and controlling organizational projects. Company-wide harmonization and professionalization of processes, from portfolio management to execution of single Projects.

ARCONDIS references

One Research & Development

Project management and program support within a multi-year initiative for the global, cross-divisional harmonization of R&D processes and the “Ways of Working.” Design of a target operating model, including a process-oriented tool landscape.

Agrar Reference

Compliant Regulatory Submission Management

Project management, business analysis and introduction of Trackwise© as a central, cross-division regulatory submission management tool. Risk minimization in relation to compliance in shipping and sales.

IDMP (Identification of Medicinal Products)

Opportunity Management through Salesforce©

License savings of > USD 300,000 annually and an efficiency increase in the evaluation of external collaboration opportunities in research and development. Optimal representation of the business process in Salesforce© and shutting down the old systems. Responsible for the total project management and business analysis.

ARCONDIS news Corporate

Excellence in Application Portfolio Management

Improvement in the transparency and control of the application portfolio management through the specification, implementation, validation and roll-out of a tailor-made application portfolio web platform, including specific workflows to ensure compliance with GxP-relevant systems.

Validation of a Document Management System

Validation of Document Management System

Efficient validation of a document management system with a punctual and inspection-proof conclusion while considering the simultaneous roll-out at two locations.

Cloud Computing

Approach to GxP compliant cloud computing

Expert consultation and workshop management on the topic of data security and compliance in the cloud for the global audit department.

ARCONDIS news Compliance

Service Agreements for Regulatory Applications

Design, creation and adoption of application service agreements (ASA) for the entire application portfolio of the regulatory area.

International Transparency Disclosure – Quick Guide

Organizational Project Management Office

Management of the global project management office for research and development computer science. Continuous development of the PM processes, assistance for project managers and monitoring of projects with respect to risk, time, costs and compliance.

Data Management

Master data management in the production environment

Standardization and consolidation of master data management in production after the merger:
Design and expansion of an in-house developed master data management system, including a GxP-compliant migration of production data and validation of the extensions.

IT Service Management

Optimization of IT service management processes

Service management gap analysis according to resource-efficient best practice procedures, including measures planning to optimize the incident and change management processes in the SAP© environment, Siebel CRM© and Cognos©.

IT Management

Compliance in Good Distribution Practices (GDP)

Efficient and timely implementation of the most up-to-date EU GDP guideline for active ingredients company-wide. Project management, compliance expert consultation and interdisciplinary coordination.

Projekte

Introduction and validation of a complaint management system

Timely introduction, including a global roll-out of a complaint management software. Assumption of overall project management, the PMO and all validation activities.

Quality Manager SAP Rollout

Quality Manager SAP Rollout

Accompanying an SAP roll-out in the role of the project quality manager at several locations in the US. Compliance and efficiency in the project processes through a “right-the-first-time” approach and communication between the specialty department, IT department and quality department.

International Transparency Disclosure

TÜV Audit Readiness

Successful TÜV audit through a targeted audit preparation, including review and risk-based optimization of the international CSV framework as well as the professional supervision of the audit itself.

ARCONDIS News

ISO 27001 Internal Audit

Assumption of overall responsibility for intra-corporate IT security audit based on ISO 27001, from planning to implementation and follow-up.

ARCONDIS News

Optimierung Batch Record Prozess

Optimierung der Batch-Record-Prozesse im Bereich Sensor Operations inklusive CAPA- und Deviation Management Prozeduren.

News Information Management

Business Process Management Framework

Increasing efficiency and transparency of business and quality processes through the design and introduction of a lean process framework, including tool support. Reducing interfaces, accelerating and streamlining end-to-end processes, avoiding handover gaps and laying the foundation for fast and flexible process adjustments.

Komplexe Transferprojekte - Compliance

GxP compliance after merger integration

Ensuring GxP compliance with the system landscape after the merger, including migration planning, validation implementation and reporting in the SAP solution manager.

IDMP (Identifikation von Arzneimitteln)

Implement Manufacturing Execution System (MES) in GMP-regulated environment

Selection, implementation and validation of a manufacturing execution system (MES) with a global roll-out: Cost savings by reducing the operational footprint, harmonizing and streamlining the workflow, including the introduction of electronic batch records.

Compliance IT Management

Increase in study management performance

Increase in the studies productivity and performance of various research organizations through process review, development of prediction parameters with respect to the FPI achievement and realization of cost savings through early study termination for non-performing studies.

Service Agreements für Regulatory Applications

Lean Compliance

Lean, efficient and inspection-proof GxP compliance through the reorganization of the QA/QC function, re-engineering of business processes, validation of business applications.

IT Management

Service-Oriented IT Organization

Increase in efficiency and quality of IT services by setting up a service-oriented IT organization. Introduction of global IT service management processes, including optimization of the interface to the external call center and implementation of a service management tool.

ARCONDIS News IT Management

Global migration from Lotus Notes to Office 365

The successful migration of notes to the cloud-based, flexible Office 365 Suite from Microsoft within just one year. Technical project management and business analysis for the migration of more than 100,000 mailboxes. Operational integration of various office processes, including service management processes.

Outsourcing von Managed Print Services

Outsourcing of Managed Print Services

20% savings of operational print costs through the harmonization and outsourcing of print services at the headquarters with 100 buildings and more than 12,000 users. Program management, design of the new infrastructure, roll-out management and implementation as well as setup of the operational service.

Komplexe Transferprojekte - Compliance

Outsourcing Readiness for IT Infrastructure Services

Outsourcing readiness of the IT infrastructure at the headquarters as part of a global program. Achieving transparency through the internal cost structure and the current inventory as a prerequisite for the standardization and outsourcing of the IT services.

ARCONDIS News Compliance

Data Center Consolidation

Consolidation from eleven to two new scalable data centers with state-of-the-art security, geared towards the company’s growth and the productivity goals. Cost savings for high data availability and improved business support.

Management-System

Service Management für Webex Applikation

Reduced operating costs and increased service levels while simultaneously expanding the functionality of the online meeting service Webex© for different end devices. Selection and change to a new service provider within 6 months.

Referenz_ChangeMgmt

New Pharma Operating Model - Stakeholder & Organizational Change Management

Successful implementation of a new business model, characterized by acceptance and high stakeholder satisfaction due to the first-class change and communication management. Cost savings through optimized decision-making paths and awareness in the assumption of responsibility.

ARCONDIS News

Global Windows 7 Roll-Out

Management of the corporation-wide Windows 7 roll-out in over 190 countries and for 80,000 affected users. Successful migration within 18 months, with an increase in the work efficiency through an improved System performance as well as cost savings through a consolidated, re-validated infrastructure.

ARCONDIS News

Deployment & Organizational Change Management for Google© Suite

Global deployment and organizational change management for the implementation and roll-out of the Google© app suite corporation-wide, with over 100,000 users and ten global service desks. Smooth migration and high level of acceptance among users and service desk personnel.

International Transparency Disclosure

Stakeholder & Change Management Global Windows 7 Roll-Out

Smooth migration to Windows 7 at 193 locations in just 18 months. The success is marked by excellent stakeholder satisfaction and a high level of acceptance among affected users due to the first-class, global stakeholder, change and training management.

Management-System

Electronic Trial Master File

Stakeholder and change management as part of the global introduction of a new document management system and optimized business processes for trial master files with 3,500 users.

Compliance IT Management

Compliant Protocol Deviation Handling

Optimization of global processes to manage protocol deviations in clinical studies, including the introduction of a web application with CTMS interfaces as a user-friendly support tool.
Benefits: Real-time analysis of protocol deviations, compliance with audit requirements, streamlining and harmonization

IDMP (Identifikation von Arzneimitteln)

Monitor Affiliate Medical Performance

Requirements management and implementation of a web platform to monitor medical affair standards, compliance and performance of subsidiaries, including reporting based on relevant key performance indicators. Simplification of data entry and benchmark capability through harmonized structures, high-level risk indication.

Health Care Professionals

EFPIA Transparency für Health Care Professionals

Compliance with the Sunshine Act / EFPIA transparency: Business process analysis, optimization of processes and requirements management for a system for the planning, tracking and disclosure of payments to health care professionals.

Product launch planning and tracking

Product Launch Planung andTracking System

Conception and implementation of a system for planning and controlling global as well as local market launches of newly developed drugs. Realized benefits: timely market launches, improved quality assurance and global harmonization of processes.

Compliance IT Management

Provisioning portal for marketing studies

Implementation of a global portal for the central management and provision of primary and secondary marketing studies. Results: reduced time to market and better quality of studies through targeted selection and improved process support

Forschungszentrums

Research Center Move

Coordination of the transfer of research applications, including adjustments to the target location and knowledge transfer to the new location. Cost savings due to the simultaneous optimization of the application portfolio and reduction of the operational footprint.

Compliance IT Management

Electronic Lab Notebook

Project management, manufacturer selection and change management as part of the conversion from handwritten labor journals to electronic lab notebooks for faster reporting and a more efficient exchange of data.

Research & Development

R&D Image Management

Evaluation and launch of an image management system for research and development at five locations of a global pharmaceutical corporation. Time savings of six hours per reporting through a one-click solution. Efficient and safe image data exchange between corporation, CROs and universities.

IDMP Compliance

Optimized Reagent Ordering

Evaluation and launch of a state-of-the-art reagent ordering system for research and development, including SAP interfaces. Time and cost savings through more efficient handling and better support of the business process.

ARCONDIS Referenzen Pharma

Compliance to EU GMP Annex 16

Ensuring Annex 16 Readiness in a timely manner for the entry into force in mid-2016 through the targeted optimization and adaptation of the business processes and the supporting application infrastructure. Program management, compliance expertise, business analysis and master data management.

Forschungszentrums

Compliant Transfer of Production Site

Management of a GxP-compliant international transfer of a production facility with over 70 production processes. Coordination of all activities relating to processes, equipment, test methods, IT infrastructure, applications and expertise. Adoption of validation activities.

News Information Management

Research Data System

Introduction of a system for the integration and optimized searchability of chemical and biological research data. Significant improvements in the field of data mining and a significant increase in efficiency.

Health Care Professionals

Understanding Disease Platform

Improvement of analytical capabilities and exchange in the fields of study of genomics, proteomics and transcriptomics through the introduction of a knowledge database with consolidated study data, including a specifically developed semantics search.