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 Viatris.

Location: Argentina, Chile, United States Of America
Client: Viatris
Industry: Healthcare
Service: Dedicated Teams
Expertise: Software Development
Technologies: Microsoft .NET 2.0 con ASP .NET y VB .NET Azure

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.

Mylan
Mylan

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 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.

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.

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 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.

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.

Case Studies

Corrective and evolutionary maintenance project.

Corrective and evolutionary maintenance project.

Corrective and Evolutionary Maintenance Project.Architecture and development of a solution for sending massive emails through a microservice, corrective and evolutionary support of the application.Location: United StatesClient: QuantifiedIndustry: Information...

Real Time Processing + Cloud Storage Optimization

Real Time Processing + Cloud Storage Optimization

Real time processing + Cloud Storage Optimization. McAfee wanted to design, develop and implement a new cloud-based technical architecture that would allow them to find a balance between storage costs, real-time processing capacity and improved response time....

Cancer Treatment Follow-up App.

Cancer Treatment Follow-up App.

Cancer Treatment Follow-up App.In conjunction with the client we designed and implemented an automated testing strategy for software applications considered core to their business continuity.Location: United StatesClient: OZIndustry: Information TechnologyService:...

Let’s get there, together

Tell us about your need and will get in touch asap.



    Would you like to join Huenei’s Tribe?

    ¡Click here and join us!