SERVICES

• Pharmaceutical Digital Twin Technology: 3D Modeling Of Facilities And Systems

  Leverage our state-of-the-art virtual twin technology for powerful insights, collaboration, and decision-making. Our partnerships with NavVis Digital Twin Technology and Prevu3D empower us to create detailed 3D representations of your systems, facilities, operations, and real-time data to enhance facility management.

• Compliance & Regulatory Programs For Drug Manufacturing

  Our experts implement proven, streamlined processes that maintain compliance, quality standards, and efficiency while also managing costs, schedules, and scope.

   

• Pharmaceutical Digital Transformation & Harmonization Programs

  Life Sciences companies are frequently slowed by siloed departments, outdated technologies, and stalled communications between office locations.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.

• Pharmaceutical Operational Readiness Programs

  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.

• Computer Software Assurance (CSA) And Computer System Validation (CSV)

  CAI’s Kneat: Data Ready provides you with best-in-class content and templates created by industry-leaders, giving you a headstart in implementing your own Kneat solution.

  Kneat: Data Ready offers not only templates, but a validated out-of-the-box configuration that you can tailor to your business needs. Implement your Kneat instance in less than half the time.

• Validation And Quality Management Software Platform

  Kneat enables regulated companies to consolidate validation and quality management into a single end-to-end web-based software platform.

  CAI’s Kneat: Project-Ready allows your company to utilize a validated Kneat instance to execute your projects without start-up and on-going maintenance. Project-Ready does the heavy lifting for you with pre-designed processes and templates.

• Pharmaceutical Program & Project Management Services

  Our PPM team has significant experience in assisting owners with the development of clean, compliant facilities and processes for companies around the globe. We have the proven ability to develop the design concept, the construction plan/components, and procurement strategy. This ability coupled with a deep understanding of financial analytics required to make projects a reality help us to produce successful projects for our clients. Many of our PPM team members have previously sat in the end-user chair and now are able to assist other firms, like yourself.

• Pharmaceutical Automation And Information Technology Services

  As a company that specializes in troubleshooting complex systems and equipment, especially in regulated industries, we have gained expertise in Automation & Information Technology (IT) systems. These systems are the foundation of the manufacturing equipment and processes we have been commissioning and qualifying for over 20 years. Our teams work to deliver fully functional and compliant, mechanical and automated systems to our clients. Our expertise extends from specification, through implementation and startup, and into true process optimization.

• Quality, Compliance, And Regulatory Services For Life Sciences

  The biotechnology, medical device, and pharmaceutical industries are highly regulated globally by a diverse group of agencies. Assuring GMP Quality and Regulatory Compliance throughout your supply chain is a challenge. Meeting this challenge requires a successful interaction between knowledge, systems, and people.

• Pharmaceutical Asset Management & Reliability Services

  Asset Management & Reliability (AMR) focuses on preserving asset functions. These functions are determined by our clients’ business strategy. The focus is on producing products that conform to consumer needs in the most efficient and cost-effective manner. While conditions vary, the common factor with manufacturing process is reliability. We help our clients determine which best practices are applicable in your industry and how best to deploy them.

• Pharmaceutical Facility Commissioning Services

  Having your commissioning agent (CxA) involved in the design phase brings value that is not realized until the project is finished. A CxA has been through many different configurations and knows what works and what does not.

• Pharmaceutical Commissioning & Qualification Services

  We set the industry standard when it comes to commissioning and qualification project delivery.

• Biopharmaceutical Process & Manufacturing Technology Services

  In your organization, there are constant challenges to streamline post-approval changes to meet market demand and prevent drug shortages. Critical to a streamlined process is robust process change management with targeted assessments giving you the desired outcome to reduce deviations, lower cost of quality, and enhance your regulatory strategy.