Digital Revolution in Pharma Quality Control

Emerging technologies can make quality control (QC) faster and more efficient.

The emerging technologies that characterize Industry 4.0—from connectivity to advanced analytics, robotics and automation—have the potential to revolutionize every element of pharma manufacturing labs within the next five to ten years. Digitization will also ensure better quality and compliance by reducing manual errors and variability, as well as allowing faster and effective resolution of problems. Use cases have demonstrated more than 65 percent reduction in deviations and over 90 percent faster closure times. Prevention of major compliance issues can in itself be worth millions in cost savings. Furthermore, improved agility and shorter testing time can reduce QC-lab lead times by 60 to 70 percent and eventually lead to real-time releases.

While most of the advanced technologies already exist today, few pharmaceutical companies have seen any significant benefits yet. On one side, quality leaders often struggle to define a clear business case for the technological changes, which makes it difficult for them to convince senior management that lab digitization can deliver significant impact. On the other side, companies rarely develop a clear long-term lab-evolution strategy and blueprint, which can lead to some costly investments with unclear benefits. For example, many…