We are upgrading a pharmaceutical company’s document management system, which is designed to support the transparent documentation of pharmaceutical research and development activities and ensure compliance with regulatory requirements.
Sector
Service & Technology
The Challenge
Our client is a leading pharmaceutical company in Hungary with significant research and development activities. Among the systems supporting pharmaceutical research and development, the company issued a tender for the upgrade and five-year system support of its document management system, which was won by DSS Consulting.
The Solution
As a first step, DSS Consulting became thoroughly familiar with the requirements (required technologies, methodology, etc.) and acquired the necessary domain expertise, including the regulations required for GxP compliance.
We then assembled the project team with four senior experts to deliver the project – an architect, a lead developer, a business analyst, and a tester. For this custom development, we used Java for the backend and Angular for the frontend, and the system’s database is an MSSQL-based database.
The backbone of the system is a folder structure within which various documents can be created, edited, and approved. Another key feature of the system is its multi-level authorization management.
A major challenge during the project was ensuring that the system documentation (from specifications to test documentation) met strict requirements to ensure GxP compliance, given the highly regulated nature of the pharmaceutical industry.
Technology
Java, Angular, MS SQL, MS SharePoint, IBM FileNet
The Result
The development phase has been completed (including the first round of testing); we are currently processing and implementing additional feature requests from the client. The next step is user testing, after which the system can go live.
We plan to incorporate any modification requests received from users during live operation, as well as to continue the technological upgrade of the entire system.
