To capture opportunities offered by existing and emerging technological advances, companies should set clear goals, define robust business cases for any level of investment, and engage in rapid piloting of the new technologies followed by fast scale-up of pilots that deliver promising results.
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Now those moves are being superseded by new advances in equipment connectivity that enable direct transcription of thousands of data points without any manual data transcription and without any reviews. For example, many companies have already taken steps to become paperless by first simplifying paper records to minimize the number of entries and then digitizing lab testing records. 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. 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 or automation can deliver significant impact. While most of the advanced technologies already exist today, few pharmaceutical companies have seen any significant benefits yet. 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. Prevention of major compliance issues can in itself be worth millions in cost savings.
Use cases have demonstrated more than 65 percent reduction in deviations and over 90 percent faster closure times. Digitization and automation will also ensure better quality and compliance by reducing manual errors and variability, as well as allowing faster and effective resolution of problems.
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The first real-life use cases have delivered 30 to 40 percent increases in productivity within already mature and efficient lab environments, and a full range of improvements could lead to reductions of more than 50 percent in overall quality-control costs. 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.
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