Application Management Outsourcing

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 Mylan.

Location: Argentina, Chile, United States of America.

Client: Mylan.

Industry: Healthcare.

Servicce: Dedicated Teams.

Expertise: Software Development.

Tecnologies: Microsoft .NET 2.0 con ASP .NET y VB .NET Azure.

Background​

Mylan 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, Mylan 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 Objective

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

A series of customizations of the framework of the ITIL methodology were carried out to comply with a series of good practices of the company, for this it was necessary to form a technical team that had experience in said methodology, managing to implement the service model.

Additionally, an Azure-based high availability infrastructure was implemented for Argentina and Chile, all this carefully supervised by an external consultant, who ensured that the processes and quality standards of the Pharmacovigilance program were met.

To ensure completeness and correctness of the information, anomaly detection parameters were configured that will be notified after processing the files.

Results 

Outsourcing of the complete management of the drug-surveillance program in the countries required by the client, aligned with demanding industry standards, and metrics that guarantee the established service level agreement must be permanently controlled.

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