How Chemical Manufacturing and Control (CMC) Software Helped a Major Pharmaceutical Company Improve Process Development and Regulatory Submissions

Background: in 2019, a process development team at a top biopharmaceutical company. They felt data management was getting in the way of research and that too much time was spent preparing regulatory submissions.

Challenge: the team wanted to streamline chemical and process data management and lower their dependence on unreliable Excel spreadsheets. They also wanted to bring together data from across their ELNs to reduce the time spent tracking down experimental results.

Solution: the team used a CMC decision support tool to consolidate their process and analytical data in one interface. This software allowed the team to bridge the gaps in data management, leading to improved decision making, convenient data visualization, and simplifying batch comparison.

Topics covered in this case study:

  • Why Excel is not sufficient for managing data during pharmaceutical development
  • Enhancing decision making and fostering a culture of data sharing
  • How CMC data management software can increase regulatory submission efficiency by >30%
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