Digitization and automation have been on the rise in the life sciences industry for years. The systems they use generate and process vast quantities of data — data that forms the basis for all decisions, including those with a profound effect on product quality and patient safety.
Because you and your patients must be able to depend on your decisions at all times, data integrity is paramount. We help you to master this complexity, to comply with the regulatory requirements, and to maintain complete, reliable, correct, and consistent data.
Our consulting team analyzes and evaluates your existing data integrity to detect potential weaknesses and risks and to define appropriate measures. In addition, we also support you with our expert knowledge of the regulatory requirements of the Food and Drug Administration (FDA), the Medicines and Healthcare products Regulatory Agency (MHRA), and the European Medicines Agency (EMA), as well as in the application of the ALCOA+ Principles*.
We here at Körber ensure that the sector’s best experts look after the evaluation and optimization of your processes.
*Attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, available