Viatris AMO.
Application management outsourcing (AMO) including support and maintenance of pharmacovigilance application levels 1, 2 and 3 for drugs in Argentina and Chile, through ITIL methodology, in accordance with good practices (GxP) required by Viatris.
Industry: Healthcare
Client: Viatris
Service: Application Management Outsourcing
Engagement Model: Application Management
Technologies: Microsoft, .NET 2.0 con ASP, .NET, VB .NET Azure
Background.
Viatris needed to put in place a pharmacovigilance program for a product that required this kind of monitoring in some of the markets where it was marketed. For this, they needed a partner who had experience in the pharmaceutical industry, as well as in the management of medicines under a monitoring regime, who could implement and be in charge of the outsourcing of the application management.
Challenges.
After acquiring the marketing and distribution of Clozapine, Viatris needed to maintain the operation of the pharmacovigilance application for the proper attention of consumers, so it needed to find a partner who had experience in the pharmaceutical industry, as well as in the management of medications under a follow-up regimen.
Business Goals.
Maintain compliance with global regulations of the pharmacovigilance program for a particular product marketed by the laboratory, as well as in improving the current technological platform that allows such management. For this, the hiring of an application management outsourcing (AMO) service that contemplates the maintenance and support of levels 1, 2 and 3, aligned with ITIL methodology, was determined.
Solution.
Once Huenei’s pharmacovigilance solution was implemented, we began providing Application Management Outsourcing (AMO) services. This included ongoing maintenance, management, conversion, improvement, and support of the solution, ensuring compliance with the stringent service level agreements in place. Maintenance activities encompassed regulatory changes, software updates, new installations, and problem resolution.
Initially, we defined the service delivery model by customizing an ITIL-based process framework to meet the client’s required best practices. Additionally, we implemented a high-availability infrastructure based on Azure for the countries where the solution was deployed.
Results.
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