Don’t let misaligned teams, missed targets and delays derail your facility startup. Follow the CAI framework to overcome common pitfalls and reach Operational Readiness.
The CAI Operational Readiness Framework is a consistent, repeatable process for life sciences facilities to achieve safe, efficient and compliant startups.
Field-tested and trusted by industry leaders, the framework is built with the Six Pillars. Readiness occurs when each pillar is successful and all six are aligned with one another.
The Six Pillars:
Strategy Leadership: Unified direction, culture and commitment across teams and systems for alignment and accountability to operational success
Execution Excellence: Readiness based on measurable outcomes via planning, risk management and continuous improvement for high-performance operations
Workforce Capability: All staff are supported, trained, qualified and clear on their roles and ready to perform on Day One
Facility & Equipment Readiness: Facilities, equipment and utilities designed, installed, tested and maintained to meet operational needs
Digital & Data Enablement: Digital systems and data flows are strategically designed to support rapid project delivery, better decision-making and efficiency
Quality Advancement: Quality and regulatory practices are best in class and phase-appropriate supporting operational agility and long-term performance
* Figures reflect CAI internal data and reasonable estimates accumulated over 30 years of operations, 1996–2026.
Every piece of equipment CAI validates has a life far beyond the facility floor. When we validate a dosage form machine, that machine may produce a billion doses over its service life — medicines that reach patients around the world. Across 30 years and roughly 3,000 validated machines.
“Looking back on the past three decades, I’m incredibly proud of how far our company has come and the role our people have played in supporting the safe, efficient delivery of medicines and critical therapies to patients worldwide. Our growth has always been driven by listening to our clients and anticipating what they’ll need next. As we enter our fourth decade, that commitment is unwavering and guides us to help shape the future of life sciences and mission-critical operations.”
Robert Chew
Founder
“At the heart of our sustained success is our amazing team of experts that continuously support operational readiness and excellence. Through a shared commitment to doing the work right, our employees are empowered to develop solutions, share lessons learned, and continuously raise the bar. That collective expertise is how we deliver consistent results across projects of varying sizes and complexities across the globe.”
Sheena Dempsey
Chief Executive Officer
CAI was built on the belief that operational readiness isn’t a checkbox — it’s a foundation. For every client we’ve partnered with, every system we’ve validated, every readiness milestone we’ve helped achieve, the goal has always been the same: make what’s next possible.