- Datum
- 29. March 2023
We analyze and evaluate the regulatory requirements for registering a medical device software as a German digital health application (DiGA) using the fast track approach established by the BfArM. This includes performing an MDD-to-MDR gap analysis on technical documentation and determining binding delivery conditions that take into account important factors such as data protection, information security, clinical safety, functionality, and quality. This will help gain a competitive advantage in accessing the medical market.- Datum
- 16. February 2023
The biocidal applicability and hereafter requirements as well as costs and timelines for the registration of an innovative antimicrobial biocidal product are investigated, the registration options are evaluated and visualized into a clear basis for decision-making regarding further use and distribution in the EU and Switzerland for the management. In addition to the project management, we are responsible for evaluating the active ingredient identity and clarifying the regulatory status, summarizing the national registration requirements in Switzerland and the EU, and developing strategic recommendations for action.- Datum
- 27. January 2023
The restructuring and content revision of the ITSM service catalog of a Cantonal administration as well as the re-design and implementation of an intuitive user interface for the Matrix42 tool increases the efficiency, improves the user experience and facilitates the work of the ITSM team as well as their customers in daily operations. Also part of the project is the development of a knowledge base as well as the creation of factsheets for the departments and blue light organizations affected by the change.- Datum
- 26. January 2023
Creation of the basis for digital application up to release/rejection by a new commission. Associated processes as well as a scalable, individual system solution are developed in an agile manner and inserted into the existing IT architecture of the Canton in accordance with the requirements of a records system. HERMES 5.1 is applied efficiently and special attention is devoted to the needs of the individual stakeholders.- Datum
- 26. January 2023
With the expiry of the lease of one location, all activities in the region are to be consolidated at one innovation hub and modern workplaces are to be created. Project management and coordination of the timely relocation of around 500 workstations, including the introduction of a modern mobile office concept and the infrastructure for a desk sharing booking system that enables flexible working in the office and at home.- Datum
- 30. November 2022
Reducing the workload of the team leader of the IT department of a cantonal administration with regard to his role as service owner. The activities include ensuring that functional managers can provide their services in accordance with the service level agreement and that the associated processes are complied with, documented and implemented in the central tool. This also includes the creation of emergency documentation in the event of a disaster, e.g. cyberattacks.- Datum
- 30. November 2022
The regulatory-critical database of a pharmaceutical company is migrated from Oracle 11 to MSSQL, tested and validated according to GAMP5. By introducing efficient project structures, the deadline of only two months can be met without interrupting business processes.- Datum
- 30. November 2022
Harmonization through the introduction of central and continuous end-to-end monitoring of a cantonal administration reduces the complexity of interfaces and responsibilities. By replacing the existing individual solutions, license savings can also be generated. What's special: The combination of HERMES and SCRUM ensures an efficient project structure and handles all activities in simplified sprints.- Datum
- 30. November 2022
Automation of regulatory affairs business processes through the introduction of rule-based workflows. The implementation and validation of a digital platform solution (SaaS) enhances the management of electronic submissions and regulatory documents. This streamlines the compilation, publication, approval and management of regulatory activities in the lifecycle of pharmaceutical products. With this approach we enable and ensure that legacy systems are replaced, and data is migrated correctly and completely in a timely manner to maintain GxP compliance.- Datum
- 30. November 2022
Reduction of workload for the ITSM team of a public administration as service manager ad interim. Improvement of the cantonal service and support in service and account management including responsibility for the ITSM tool, communication with stakeholders and suppliers as well as setting up a data-driven Power BI reporting for monitoring and as support in decision making.- Datum
- 30. November 2022
Developing a cause/effect chain that maps the complex interrelationships and challenges in the overall macroeconomic context through workshops with representatives from the various divisions of a cantonal location promotion department. A specially designed dashboard with measurable KPIs serves the continuous monitoring of the identified success factors, objectives and influencing variables.- Datum
- 30. November 2022
Successfully updated and validated a pharmaceutical company's regulatory critical application within a tight timeframe. Established efficient structures, closely tracked all activities, and quickly resolved challenges to ensure compliance without prolonged business process disruptions.- Datum
- 16. December 2021
In the course of the divestment of a corporate unit, the data of nine locations is migrated from the existing intranet solution to MS SharePoint, including critical data covered by the Chemical Weapons Convention. This enables online collaboration and - thanks to clean-up and restructuring - increases data quality. Efficient migration planning means daily operations are not impacted.- Datum
- 11. October 2021
Introduction and harmonization of agile portfolio, project and resource management for the successful management of all at times complex initiatives and projects in the lab environment. The central project control processes increase transparency in planning and sustainably support the corporate strategy and associated growth targets.- Datum
- 11. October 2021
Introduction of an end-to-end Regulatory Information Management in the cloud (LifeSphere RIMS), migration of data via 5 interfaces as well as definition and training of associated processes with the goal of creating a source that unifies all data and creates a complete overview of the status of all documentation. More efficient structures and solving the challenges of previous applications provide a higher quality in data management. Efficient project planning with a test matrix to track all ongoing activities and a total of 875+ test steps ensured that resources were used sparingly.- Datum
- 11. October 2021
Redesign of organization and operating model incl. roles and responsibilities for the IT infrastructure and support organization in close cooperation with the head of the global IT infrastructure department for 100+ employees. Development of a change and communication plan for the redesign of the organization incl. preparation of communication materials.- Datum
- 11. October 2021
Identification of the most important IT infrastructure projects for the coming year, taking into account the available budget. Prioritization of the project portfolio with 50+ projects and 10+ stakeholders based on defined evaluation criteria and corresponding weighting.- Datum
- 7. January 2021
Introduction of Windows 10 and Office 365 at WIR Bank as a basis for future remote collaboration in compliance with strict security guidelines. Thanks to the MVP approach, testing and effort for the business side could be kept low and quality high. The implementation project was preceded by an assessment in which the most suitable infrastructure solution was evaluated with regard to long-term business goals.- Datum
- 14. August 2020
Improving production processes in the food industry in terms of effectiveness, safety, traceability and other quality standards. As part of this, assessing existing, highly automated production processes, creating improvement concepts which fit into the given setup and documenting process changes.- Datum
- 14. August 2020
Engineering of complex systems and processes for an international company in the plastics industry. This includes the responsibility for contractual agreements and the documentation of components and processes, taking into account the constructive and mechanical design according to German, Chinese and US-American standards.- Datum
- 14. August 2020
We enable the transition of medical device development projects from design to serial production, while ensuring adherence to quality and compliance standards. This includes creating process documentation, qualifying equipment, and integrating stakeholder input with process requirements. We manage, control and optimize the projects to enhance both production processes and related validation activities.- Datum
- 14. August 2020
Reorganization of the entire processes from planning to packaging to delivery of pharmaceutical products by 200 dispatchers in 6 regions increases market responsiveness. Systems, communication flows and roles are adapted for this purpose. Targeted OCM with extended stakeholder analysis, supporters at the sites and training of all stakeholders worldwide ensure an accepted introduction and sustainable anchoring within the organization.- Datum
- 14. August 2020
Setting up the validation strategy for the SAP in a medical device company. Documenting existing processes including IQ, OQ and PQ with a hands-on approach mitigate prior audit findings in a quick and sustainable manner.- Datum
- 14. August 2020
Assessing as-is status, identifying gaps and establishing a global security architecture for 20+ pharmaceutical manufacturing labs worldwide with the goal to not only enhance manufacturing and R&D network security but also reduce the risks to production of medicines and to negative impacts on patients.- Datum
- 6. June 2020
The outsourcing of the entire infrastructure to a virtual working environment allows the 8,000 employees of a public administration to work from anywhere and with any device. For this purpose, the server infrastructure is set up and the necessary software and devices are provided. Uniform cantonal standards are created through the development of a service catalog, service organization and operating manual.- Datum
- 6. June 2020
In the context of divesting parts of the company, an outsourced service center is to be reintegrated into the company. In order to avoid the disruption of ongoing operations, the non-active side of the infrastructure and telephony system are first moved to Shanghai and configured. Afterwards, the control center is operated from the new location, while the second part of the components is added to restore the full redundancy of the system.- Datum
- 6. June 2020
Digitalization of research processes previously documented mostly on paper and in Excel through the introduction of the cloud-based ELN software solution Dotmatics for desktop as well as on mobile devices for 1,600 users at 20 locations worldwide. In preparation, a global requirements analysis will be conducted and the necessary infrastructure in terms of performance and coverage will be provided locally.- Datum
- 20. April 2020
In order to increase cost efficiency, a service catalogue is to be developed which will provide clarity as to which services are provided at what cost and how. The focus is on user-centered descriptions and a segmentation of the services as well as their internal marketing. In addition, an organization for the management and development of the services are established.- Datum
- 20. April 2020
An NPO sets itself the goal of making its region the world's leading location for “Digital Precision Medicine”. As a sparring partner and workshop moderator, our responsibilty is to examine and question the strategy in order to sharpen its focus and create clarity of results.- Datum
- 20. April 2020
Developing an innovative, digital strategy for the next five years, including a roadmap and investment planning, for a public transport company as interim head of the ICT department with 25 employees. The key challenge here: the investment-intensive environment is facing ever shorter innovation cycles. As an additional benefit, we also stabilize the operational business and its key projects.- Datum
- 17. April 2020
The introduction of the Veeva Vault solution creates a digital, harmonized, and agile end-to-end manufacturing process that can be seamlessly integrated into the existing system landscape. This simplifies processes on a global scale and reduces operating costs by 20%.- Datum
- 18. March 2020
As time constraints didn’t allow for a well-proven approach, a more agile, yet still cohesive method was necessary to allow users instant access to MS Teams without creating chaos. The solution: A crash-course and extensive first level support to ensure basic guidelines are met. And, subsequently, the definition and introduction of a proper governance to secure long-term benefits.- Datum
- 17. February 2020
With harmonized, centrally managed print services at headquarters, printing costs can be reduced by 20%. The migration concept, from the business case to operational implementation, covers 10,000 devices in 100 buildings.- Datum
- 17. February 2020
The introduction and global rollout of a customized, cloud-based portfolio management system for all GxP-relevant applications improves data quality and thus decision-making. Approval workflows ensure that the validated status is maintained.- Datum
- 17. February 2020
Following the split of a company, a new, independent technical environment with a central application inventory is created. With a sequential approach, 350 applications are migrated and rolled out at 10 locations for 4500 users. In addition, 100 GxP-relevant applications are validated.