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Regulatory Affairs departments are under increasing pressure to deliver labour-intensive work. Much of this work is still manual, is open to change, and as laws are updated, globalisation becomes the norm and growing data sources come into play.

Regulatory submissions are both time and labour-intensive, requiring organisations to carry out activities that include tracking the status of documents and compiling records to create a dossier. Gathering materials across disparate functional areas for inclusion in regulatory submissions or determining whether these documents adhere to regulatory standards are not value-added functions.

Significant aspects of these tasks can be automated using technologies such as Optical Character Recognition (OCR) and Robotic Process Automation (RPA). OCR is a technology that enables you to convert different types of documents, such as scanned paper documents or PDF files into editable and searchable data. Combining OCR with RPA to take that digitised data and use it to fill in forms, reports etc. can significantly reduce process time and allows RA teams to focus on discrepancies rather than doing the manual low-level paperwork.

If you’d like to find out more about how automation technology can unlock process efficiency in Pharma, then be sure to get in touch with the Proservartner team.


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