Process Validation and Product Quality Reporting Solution
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Process Validation and Product Quality Reporting Solution

Process Validation and Product Quality Reporting Solution for a Global Leader in Life Sciences and Biotechnology

About the solution

For a global leader in life sciences and biotechnology, BGO Software developed a web-based data reporting solution. The system aggregates data collected in various systems and from various physical devices and enables non-experts, scientific and managerial users to generate automated verified data summary reports. Due to the specifics of the customers and its work in a regulated environment, the software solution needed to meet multiple requirements for the data handled, features implemented and security standards. 

 

Customer

Global leader in life science and biotechnology

Location

Europe/North America

Developers Team

2 Back-end Developers, 3 Front-end Developers, QA and Project Manager

Presentation

Involvement

Project Management Methodology

Challenge

The customer for which we developed the data reporting solution is an innovator delivering manufacturing and process excellence. The company develops small molecule drug substances and their intermediates, which are further used in the manufacturing process of vaccines and a variety of medicines. The quality of service, regulatory track record and extensive experience makes our customer a preferred global partner to the pharmaceutical, biotech and specialty ingredients markets. 

The process of delivery of small molecules, monoclonal antibodies, complex proteins and recombinant proteins is tightly connected with the usage of a wide range of physical devices and collecting data from devices and various processes. Before implementing the solution, developed by BGO Software, the customer was struggling to collect a large set of information in different systems. A centralised system was not in place, which was making the work of physicians complex and time-consuming. The customer needed a single solution, which can easily aggregate data from various systems and generate custom reports to help them analyse the data collected. 

Solution

BGO Software developed a data reporting system that enables non-expert, scientific and managerial users to generate automated verified data summary reports of different kinds:

  • Process Validation Reports
  • Product Quality Review
  • Continued Process Verification
  • Deviations Reports

The system, developed by us was integrated with various systems of record available in place and consolidated all data into a centralized location. The is now presented in version-controlled reports, tables, and other formats.

To meet the regulatory requirements and to ensure compliance, the system is not storing any data inside but just pulls the needed data sets for the specific reports. All reports are fully customizable according to the customer’s needs and project requirements. 

Тhe reporting solution supports a web user interface for end-users and administrators, as well as REST API for communicating with external systems. In addition to the reporting capabilities, the web-based solution supports also smart alarms and event-based notifications, report templates, data exports, user groups and roles, administration features, user activities, audit trails and logs and many more.  

Results