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Vorstellung der Kundenchallenge
Erstes kennenlernen und Gewinnung Verständnis der Problemstellung. Kurzvorstellung der TopEase®-Plattform.
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Quick overview and detailed reporting of which risks exist. Automatic prioritization and trend detection for risks. Free definition of the risk matrix (e.g. 4×4, 5×5) and description of the Risk Probability and Risk Severity.
Graphical representation per risk of how the risk is to be developed in terms of probability and severity. Release of the risk via workflow. Full traceability of risk assessment and verification via historization function.
Complete planning of all measures to minimize risks. Measures are assigned to the relevant risks, and the effectiveness of the measure can be evaluated via renewed risk assessment.
Risk 1 Mitigation
50%
Risk 2 Mitigation
64%
Risk 3 Mitigation
57%
Risk 4 Mitigation
22%
Individual progress displays and customizing possible. Live dashboard for a quick overview of the implementation of measures.
Quick overview through automated reports. Standard reports out-of-the-box as well as own individual reports possible. Reports can also be generated, for example, as part of approval workflows.
Fully link risks to measures, processes, assets, and controls. In addition, assignment of e.g. threats and events possible.
Easy recording of processes, linking with controls, assets and risks possible
Simple governance of processes, implementation of responsibilities and control of roles & rights e.g. via Active Directory
Workflow-based release of processes and work instructions / standard operating procedures
Information control instead of document control for traceability of all changes and release statuses
Export of all information, such as standard process descriptions as PDFs
Representation of process maps and process houses. Complete graphical navigation via process graphics possible.
Display of the supplier structure by country in order to be able to quickly optimize the supply chain in the event of export restrictions, for example.
Aggregated display of current process statuses (number of processes in release, released processes, processes in revision, etc.).
Existing templates on risk management and e.g. Capa processes.
Reporting templates e.g. for work instructions or SIPOC reports.
Reporting templates e.g. for work instructions or SIPOC reports.
Due to regulatory changes such as the Hospital Future Act (KHZG) and the Patient Data Protection Act (PDSG), the requirements for IT security and the protection of patient data are changing for hospitals. In addition to the introduction of an ISMS solution, this often requires the introduction of a process and quality management system to document the relevant core processes. In addition, we recommend the introduction of an internal control system (ICS) for the digital documentation and implementation of the regulatory required and operationally required controls within the processes.
The introduction of digital health apps (DiGa) and digital care apps (DiPa) makes it possible for the first time to include apps in the standard care provided by statutory health insurers. For this purpose, the legislator requires the implementation of a quality, risk and information security management via the medical device certification. We offer tailor-made solutions, especially for startups, which support the necessary regulatory documentation in a software-based way and grow with the company. Our approach of software-supported documentation avoids duplication of work and high follow-up costs in further certification through intelligent networking of all relevant information. Depending on the phase of the startup, the solution can be adapted to the needs and grows with the company.
Manufacturers of certified medical devices already have certified processes and procedures in place. Here, the challenge is often redundant systems and information, sometimes distributed across multiple locations worldwide. There are also extensive supply chains, internal and external control systems, and a variety of products and product components. With the TopEase® platform, we offer customized solutions which can be integrated into the existing application landscape via interfaces in order to create efficiencies as quickly as possible, e.g. in the area of process and supply chain management, through a uniform database. The multi-client capability ensures that the solutions can be used worldwide.
Erstes kennenlernen und Gewinnung Verständnis der Problemstellung. Kurzvorstellung der TopEase®-Plattform.
Analyse der Ist-Situation anhand der individuellen Finanzierungs- und Produktsituation. Leaner Ansatz, Fragestellungen z.B. bzgl. Produktroadmap (Planung DiGa / DiPa) und größter Handlungsbedarfe im regulatorischen Umfeld (Quick-Check Compliance), Ausarbeitung der Handlungsbedarfe, Einbeziehung von Best-Practices.
Erstellung kundenorientierter Lösungsvorschlag: Einführung von einzelnen Solutions der Digital Health Regulatory Suite anhand der Kundenbedürfnisse, Integration in die bestehende Landschaft, Betrachtung von Kosten/Nutzen. Erstellung einer Umsetzungstimeline anhand der regulatorischen Erfordernisse.
Auslieferung vorkonfigurierter Solutions z.B. für das Qualitätsmanagement. Weitere Unterstützungen der Implementierung, z.B. bei der Aufnahme und Dokumentation von Prozessen sowie der relevanten Kontrollen. Weitere Integration in die Systemlandschaft, z.B. durch Anschluss einer bestehenden CMDB Lösung.
Wir unterstützen unsere Kunden nicht nur durch weiteres Customizing und Konfiguration der Softwarelösungen, sondern auch operativ im Bereich der für die Zertifizierung notwendigen Tätigkeiten. Der Kundenvorteil besteht in unserem Expertenwissen im Bereich leaner Prozessgestaltung, End-to-End Prozessketten und Wertschöpfungsflüsse, Supplier-Management oder Informationssicherheit in der kritischen Infrastruktur.
