CAPA automation is for enterprises that have issues with collaboration between departments. In this case, automation allows introducing workflow solutions, real-time tracking, and standardized procedures. The result will be a reduced investigation time by 50–70%, which is a significant improvement.
SOP automation centres on document management. With the growth of a pharma company, the process of managing SOPs becomes decentralized and takes more time. By automating this area, a pharmaceutical company can introduce such capabilities as version control, automated review scheduling, and audit-proof training records. The implementation of such automation is not complicated and can take about 60–90 days.
Finally, batch records provide a clear business value because they contribute to improved release cycle times. Most pharmaceutical companies still have problems with batch record review processes, which can be solved using automation technology. Additionally, artificial intelligence will help to focus only on important exceptions.
In general, there is an ROI that can be seen from the implementation of automation in batch records. SOPs are best suited for standardization, and CAPA should come later when all other processes have been set up.
