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Browsing by Subject "alerts"

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  • Improving Cloud Governance by Increasing Observability 
    Nousiainen, Markus (2020)
    Rise in popularity of Cloud computing has introduced new challenges for IT-governance. The multitude of different services and possible configurations Cloud providers offer can make it hard to get a comprehensive overview of the environment. To successfully govern an organisations Cloud environment it is important to be able to easily make accurate and reliable observations of the environments state, security, and changes to the configurations. This thesis takes a look into the research literature to find out what kinds of risks have been identified in governing the Cloud environment and ways to mitigate them. One of the latest advancements in improving the Cloud governance is the introduction of automated formal reasoning tools for configuration analysis. One customer case where multiple vendors are building services on multiple cloud accounts is used as an example. Architecture for application, security, and audit log collection, indexing, and monitoring is described. Special attention is given to the identity and access management requirements. The thesis concludes with the assessment of the selected approach and tools and services used to implement it. Some alternative solutions, possible improvements, and further development to the implementation are considered.
  • Lääkevarmennusjärjestelmän hälytysten hallinta Suomessa ja muualla Euroopassa 
    Kiljunen, Sanna (2021)
    The objective of this research has been to investigate the management of alerts of Medicines Verification Systems in Europe. Verification of medicines according to Falsified Medicines Directive (FMD) came into force 9.2.2019. There is no standardized tool or system for the management of alerts, every Medicines Verification Organisation and manufacturer have had to find their own ways to manage the alerts. The research has been performed as a theme survey via questionnaire that has been sent to Medicines Verification Organisations in 30 European countries. Information to the questions of the questionnaire has also been gathered from the Internet pages that are mainly maintained by the Medicines Verification Organisations. This kind of method triangulation has been used in order to improve the reliability of the research. Answering rate of the survey was 17 %. By including the information gathered by method triangulation the overall yield percent of information in this study was 45 %. The information received via the questionnaire did not contradict with the public information. As conclusion, marketing authorization holders have been registered as users of the National Medicines Verification Systems or they have signed a contract with Medicines Verification Organisations. Marketing authorization holders are paying the costs of the Medicines Verification Systems. Penalties of FMD non-compliance are in use in part of the European countries. In the beginning of the implementation of the Medicines Verification System there has been stabilization periods in use which have already ended in half of the European countries. National competent authority is informed about system alerts typically in case of suspected falsification. In half of the European countries there is a separate computerized alert management system in use. Marketing authorization holder usually has access to the system. In some of the countries it is possible to integrate the system to the own serialization system of the marketing authorization holder. In six European countries there has been set a specific time for the alert investigation of the marketing authorization holder. Based on the results of this research the alert management system that covers the whole Europe that European Medicines Verification Organization is planning would really be needed. One common computerized system and common rules would ease up the alert management of all the stakeholders of the medicines verification.
  • Lääkevarmennusjärjestelmän hälytysten hallinta Suomessa ja muualla Euroopassa 
    Kiljunen, Sanna (2021)
    The objective of this research has been to investigate the management of alerts of Medicines Verification Systems in Europe. Verification of medicines according to Falsified Medicines Directive (FMD) came into force 9.2.2019. There is no standardized tool or system for the management of alerts, every Medicines Verification Organisation and manufacturer have had to find their own ways to manage the alerts. The research has been performed as a theme survey via questionnaire that has been sent to Medicines Verification Organisations in 30 European countries. Information to the questions of the questionnaire has also been gathered from the Internet pages that are mainly maintained by the Medicines Verification Organisations. This kind of method triangulation has been used in order to improve the reliability of the research. Answering rate of the survey was 17 %. By including the information gathered by method triangulation the overall yield percent of information in this study was 45 %. The information received via the questionnaire did not contradict with the public information. As conclusion, marketing authorization holders have been registered as users of the National Medicines Verification Systems or they have signed a contract with Medicines Verification Organisations. Marketing authorization holders are paying the costs of the Medicines Verification Systems. Penalties of FMD non-compliance are in use in part of the European countries. In the beginning of the implementation of the Medicines Verification System there has been stabilization periods in use which have already ended in half of the European countries. National competent authority is informed about system alerts typically in case of suspected falsification. In half of the European countries there is a separate computerized alert management system in use. Marketing authorization holder usually has access to the system. In some of the countries it is possible to integrate the system to the own serialization system of the marketing authorization holder. In six European countries there has been set a specific time for the alert investigation of the marketing authorization holder. Based on the results of this research the alert management system that covers the whole Europe that European Medicines Verification Organization is planning would really be needed. One common computerized system and common rules would ease up the alert management of all the stakeholders of the medicines verification.

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