current landscape & challenges
R&D function is typically dispersed with hundreds of different kinds of document landscape, many of which have internal or health authority specified templates and structures.
A few of the examples include Core Product Labels, regional product labels, clinical study reports, PSUR, PADER, PBRER reports, product guidance documents, clinical overviews, study protocols, eCTD document checks, formatting & content proofing of CTD module documents, package components content checks, promotional content QC, etc. These documents further have multi-country writing variations from several global scientific document authors, leading to challenges in the quality control of these documents.
our automation solution
Using a mix of technologies and AI programming tools, we have developed automation software that provides both auto-proofreading for formatting and auto-proofreading for content. Both the methodologies will assess a number of given checkpoints for respective and designated regions on the given document or label.
The system will also perform a quality test of the output document and generate logs, and let the user know when it is ready to download the output document.