The digital lab is knocking at your door. In the age of digitalization and Industry 4.0, the laboratory is also on its way to the future. Lab 4.0 includes robotic systems, fully automated workflows, and complete integration of instruments and software systems. The software products work hand in hand and manual input from the laboratory employee is reduced to a minimum. Enterprise installations such as ERP, MES, PLS and LIMS exchange data fully automatically with each other and communicate bi-directionally with technical equipment such as balances, HPLC, GC, Bioanalyzers, PCR and many more. The laboratory employee is completely focused on his scientific work and is supported by the supporting software. The employee will work on the lab equipment and as if by magic the software will automatically create lab orders, samples, results and enter the measured values including its meta data. Raw data like AniML Files will be stored in a save place inside a database for later review on demand. Since QA/QC laboratories, clinical diagnostic and routine laboratories work according to high regulatory requirements such as 21 CFR Part 11, GAMP 5, GxP, DIN EN ISO 17025, DIN EN ISO 15189, a highly integrated and fully automatic operation saves & supports the modern laboratory as risks are reduced significantly and data is not handled manually. The example of the integration of a LIMS Middle Ware with SAP will show how such a solution can work and which special conditions should be considered. SAP represents other ERP solutions that can be integrated using the same procedure. In addition to the technical implementation, strategic and commercial aspects are also discussed, because the best technical solution is not helpful if it is not cost-neutrally feasible on a long term.

Learning Objectives:

1. Explaining the benefit of an end to end workflow (Example SAP-LIMS Middleware-SAP)

2. Understanding LAB 4.0 data structure in a modern lab (Instrument Integration & RAW data)

3. Learning about strategic & commercial key criteria for a LAB 4.0 solution