Life Sciences Solutions
For Unparalleled Operations
Top Obstacles in Life Sciences Operations
Program / Project Management & Scheduling
Managing and scheduling both programs and projects is a demanding task. We create order from the chaos. Leveraging our elite expertise and proven processes, we streamline operations to enhance efficiency.
| Your Challenges | CAI Solutions |
|---|---|
| Lack of Schedule Visibility | Independent Development of Project Master Schedule |
| Project Delays | Leverage AI for Schedule Management |
| Poor Management of Field Changes | Digital Solutions to Capture As-Builts |
| Inconsistency Across Projects | Program Management |
| Poor Information Flow | Owner’s Project Manager |
Resources & Staffing
Finding, hiring, training, and retaining top talent is a full-time job. Leverage our expertise. We deliver speed, flexibility, and scalability to every project by starting at the intersection of people and technology for superior training, performance, and outcomes.
| Your Challenges | CAI Solutions |
|---|---|
| Growing Deviations & Human Error | Leverage AI & Machine Learning for Root Cause Analysis |
| Exhausted Heroic Staff / Staff Turnover | Resource Plan Development & Process Analysis |
| Batch / Product Losses Or Release Delays | GMP University & Training |
| Inefficient Management of Assets | Lifecycle Asset Management Strategy Development |
| Lack of Data On Legacy Equipment | Asset Induction Via Digital Twin |
Compliance & Regulatory Issues
Our experts implement proven, streamlined processes that maintain compliance, quality standards, and efficiency while also managing costs, schedules, and scope.
| Your Challenges | CAI Solutions |
|---|---|
| Contamination Control | Risk Assessment And Contamination Control Strategy Development per Annex 1 |
| Lack of QP Staff | CAI QP Resourcing, QMS Program Development |
| Audit & Inspection Readiness | Compliance Readiness Review |
| Regulatory Observations | Audit Remediation |
| Excessive Deviations / CAPAs | CAPA Program Development, AI Assessment, PM to Drive Resolution |
Operational Efficiency & Reliability
Many Life Sciences companies struggle to minimize downtime, ensure safe operations, and reach tight production schedules while maintaining consistent, quality output in a demanding environment, but you can boost efficiency and reliability through our field-tested methodologies.
| Your Challenges | CAI Solutions |
|---|---|
| Delays in Production | Tech Transfer Plan, Process Risk Assessment, Operational Readiness Workshop |
| Downtime Due to Deviations | Operational Readiness Scoring & Roadmap Development |
| Lack of Requirement & Design Certainty | Prospective Planning & Design Review, QRM-Based Integrated C&Q |
| Excessive Cost of Goods & Operations | Asset Management & Supply Chain Program Development |
| Safety Events During Operations | System Safety Risk Assessments & Process Mapping & Role Planning, Use of Autoloto |
Digital Transformation & Harmonization
Life Sciences companies are frequently slowed by siloed departments, outdated technologies, and stalled communications between office locations. Streamline operations while enhancing your tech stack to deliver speed, flexibility, and scalability to every project.
| Your Challenges | CAI Solutions |
|---|---|
| Inconsistent Process Across Sites | Multiple Site Harmonization & Program Management |
| Uncertainty of New Technology Adoption | Balancing New Technology With Regulatory Compliance |
| Observations Related to Data Integrity | Implement Robust Data Management Strategy |
| Automated System Obsolescence, Sustainability and Compliance | Comprehensive Data Framework |
| Suboptimal Use of Vendor, Startup, and C&Q Data | Utilize Electronic Validation Lifecycle Management Solution – Kneat |
Are You Ready?
Let’s transform your operations, company, and patient outcomes with proven life sciences services.
Commissioning and Qualification
Ensure your facility operates at peak efficiency with our comprehensive Commissioning & Qualification services. Our experts verify that every system and component meets rigorous standards to minimize risks and ensure regulatory compliance.
Automation & Information Technology
Streamline processes and enhance productivity with our Automation & Information Technology services. Discover innovative solutions that drive efficiencies and reduce human error—while resulting in better research, products, and outcomes.
Industries
Aseptic Manufacturing
Biotechnology Manufacturing
Advanced Therapies Manufacturing
Combination Medical Device Manufacturing
Contract Manufacturing (CDMO & CMO)
Radio – pharmaceuticals
Biosimilars
