Case Studies
Performance Dashboards Development
A biotech company, preparing to launch its first drug batches, needed to implement performance measurement. CAI's global team helped identify key KPIs and built a...
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Optimized Outcomes: Achieving Faster Timelines and Cost Savings Through Digital Validation
CAI works with many companies in early phase clinical trials for whom speed to patient is of the utmost necessity. Often such companies don’t need...
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Environmental Monitoring Performance Qualification (EMPQ) and Validation Support Services
In early 2022, CAI was approached by a rapidly growing pharmaceutical/biotech company to qualify a new series of aseptic processing rooms.
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Developing Effective Procedures
Needing to develop or update your procedures? Are you sitting at your computer starting to write procedures for every subject discussed in regulations and standards,...
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Revolutionize Technical Summarization With AI-Driven Precision
Technical summarization in regulated industries presents a significant challenge. The process is crucial yet often burdensome, requiring meticulous attention to detail and strict adherence to...
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The Problem with Construction Quality
Quality management in the mission critical construction industry is underperforming. The reader need look no further for the evidence to support this assertion than to...
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Planning for a Talented Workforce: Building a Staffing Plan for New or Expanding GMP Facilities
Let’s contrast two very real scenarios: You are responsible for bringing a new GMP facility or line to full-scale production. Your board or shareholders expect...
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Building the Future of Pharmaceutical Manufacturing: A Phased Approach to Dark Factories
Why Invest in a Dark Factory? Pharmaceutical manufacturers are under increasing pressure to meet growing patient demand, accelerate drug development timelines, and adapt to evolving...
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Human Factors in Pharma Manufacturing: Beyond Error Prevention
Introduction: Why Human Error is a Failing Root Cause Pharmaceutical manufacturing operates in highly regulated, high-stakes environments where deviations can impact product quality, patient safety,...
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