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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Navigating Regulatory Complexity in Life Sciences: Turning Compliance into a Strategic Advantage
As global regulations continue to evolve, life sciences companies are facing increasing pressure to meet stringent compliance requirements without slowing down innovation or compromising product...
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A Path to Readiness Maturity: Five Phases Toward Operational Readiness
Operational readiness is not achieved overnight. It’s developed through deliberate progression across key operational domains. An organization’s readiness maturity reflects how effectively it aligns its...
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