The life sciences industry is compelled to transform efficiency across Regulatory Affairs, Quality and Pharmacovigilance/ Drug Safety functions as part of a drive to improve output while reducing costs. MAIN5’s Tobias Hitziger, explores the wider process work companies now need to do.

Rising cost pressures, downward pressure on pricing and margins, intensifying global competition, and increased product sophistication/complexity mean pharma R&D organisations have little choice but to make their operational processes as efficient as possible. That’s if they are to maximise their market opportunity and remain commercially viable.

Yet, today, across pharma Regulatory Affairs and Quality and Pharmacovigilance/Drug Safety functions, process rigour is wedded tightly to standard operating procedures (SOPs) – exhaustively documented step-by step descriptions of how things are done, to ensure a standardised way of working. Those SOPs are in most cases PDF versions of Word files, managed in an electronic document management system to ensure compliance. These snapshot definitions of processes do not, of themselves, foster efficiency nor effectiveness however.

Even where processes are improved and optimised over time, as long as these improvements are confined to a single function or sub-area, the benefits will be limited to that context. Problems commonly arise at points of handover, e.g. between teams working in the same department, or as workloads pass between different functions (or out to a service provider, and then back again). If the interfaces inhibit seamless continuity or clear visibility, momentum may be lost.