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Quality Management in e-VIS

The Quality Management System in e-VIS ensures compliance in e-VIS activities with regards to the requirements in EU Directive 2011/62/EU (Falsified Medicines Directive) as well as the Delegated Regulation 2016/161/EU. e-VIS must also be in compliance with the requirements of ISO/IEC 27001:2013 Standard, applicable parts of EU-GMP Annex 11 and 15 and GAMP (Good Automated Manufacturing Practice) i.e. quality assurance for computerised systems.

Our Quality Management System consists of policies, SOPs and working instructions that describe the core processes as well as supporting processes and clarify responsibilities. In order to continously improve e-VIS activities and the quality management system, quality objectives have been defined and are reviewed. We work proactively to identify and follow-up risks, provide training and periodically perform review of e-VIS activities as well as the activities of our IT supplier.

The Medical Products Agency (MPA) is responsible for supervising e-VIS. A voluntary assessment was performed by the MPA and EDQM (European Directorate for the Quality of Medicines) at e-VIS in August 2018 before implementation of FMD. In March 2020 e-VIS was again inspected by the MPA and EDQM, this time based on the implemented regulation.

Mock exercise in the alert management process

An alert management exercise for Swedish stakeholders was arranged by e-VIS in November 2021. The value of performing mock exercises was identified following dialogue with the Medical Products Agency. The purpose of performing this kind of exercise is:

  • To show the importance of sharing information between stakeholders and to improve associated processes
  • To increase e-VIS and all stakeholder preparedness
  • To rehearse and learn from each other within the EMVS community as a real situation with a confirmed falsification will be rare

Report from the Mock Exercise 12 November 2021