Introducing automation to a regulated laboratory – an experience report

Gröschl M | Bioanalysis, 12(10), 643–647 (2020) Keywords: 21CFRp11 • computerized system validation • laboratory automation •  liquid handling The classic operation areas for laboratory automation are clinical routine and central laboratories. The necessity to perform repetitive analysis 24/7 and the cost pressures in this area were reasons to introduce automation methods decades ago. In other laboratory areas with less repetitive work, the relationship with automation was more distant. The effort to invest in automation was often not met with the expected benefits. However, with increasing demands on throughput as well as traceability and reproducibility, automation has increasingly found a way into GxP-regulated...