Max Application developed SafetyDrugs, a centralized pharmacovigilance database to support pharmaceutical companies to meet regulatory compliance. This software streamlines the management of adverse event data, ensuring seamless data flow within the company and to regulatory authorities, while enhancing compliance and reporting accuracy.
case-studies
Safety Drugs The Safety Database
Approach and methodology
The project adopted an open minded approach, gathering input from stakeholders to ensure the application’s features met the unique needs of the Pharma Industry. Max Application developed SafetyDrugs, a centralized pharmacovigilance solution designed to simplify and automate the management of adverse event data. The user-friendly interface and modular design facilitated seamless data entry, tracking, and reporting processes. Built on Oracle technologies, SafetyDrugs provided robust data handling and compliance capabilities, ensuring that adverse event cases were managed accurately and efficiently. Continuous testing were essential to the project, reinforcing data security and regulatory compliance at each stage. By automating case management and integrating regulatory requirements, SafetyDrugs allowed pharmaceutical companies to reduce manual workload, simplify workflows and enhance reporting accuracy, ultimately ensuring compliance with global pharmacovigilance standards.
SafetyDrugs adopts an iterative approach: requirements gathering from stakeholders, intuitive interface and progressive development. Based on Oracle, it ensures safety, regulatory compliance and reliable and sound management of adverse events. Continuous testing and support guarantee solid efficiency and accuracy.
Staff involved in the project
5
Specialists
Execution time
1
Years
Technologies used
- Oracle Forms
30
%
Increased compliance with international regulation
25
%
Reduction in the time needed for case management.
Get in touch with
Abacus Group
Contact Us
Thank you for providing the required information below, marked with an asterisk (*). This will help us provide you with the best possible response.