Improving Patient Health And Safety: SOPs And Process Mapping

In this study, a biotech company faced compliance challenges due to inadequate Standard Operating Procedures (SOPs) that lacked detailed process maps. To tackle this, a ProPharma project manager initiated a comprehensive project plan centered on enhancing SOP compliance. The biotech company was also developing a new Site Relationship Management group and required help establishing SOPs and training. The strategy provided by the consultant in this case involved a process mapping exercise to offer a holistic view of the client's drug development processes. The project plan detailed tasks into specific workstreams, guiding the drafting, reviewing, and approval phases of deliverables. Through collaborative kickoff meetings with various departments, consultants facilitated the development and approval of both process maps and SOPs. This resulted in an end-to-end process map, enriching the understanding of process interactions.