Use of AWS services for automation of reporting for internal and external compliance in tablet production at a Danish-based global Pharma customer.
The customer is a global Danish-based pharmaceutical company with numerous global production facilities.
The customer wanted to reduce manual processes and increase quality in connection with internal reporting of the customer’s annual Product Quality Review (PQR) and in connection with reporting to relevant regulatory authorities.
The challenge
The challenge was to develop a solution that could deliver the annual PQR with a higher degree of automation and thus free up time for other tasks and at the same time reduce manual processes to ensure repeatable and high quality. Furthermore, an automatic linking of data would enable the customer to optimize and improve the production of tablets. Thus, we were to achieve partly an improvement in relation to reporting to internal compliance and authorities and partly a commercial advantage by optimizing production processes.
The solution
The solution was the development of a tool that automatically combines data from SAP and LIMS (Laboratory Information Management System) to generate the desired reports with data in the desired data format that meets both PQR and authority requirements.
The realized benefits for the customer were:
Simple access to data
Single point of truth
Validated data reporting
Automating the production of reports from days to minutes
Increased use of data to optimize production processes