Commissioning & Qualification

We set the industry standard when it comes to commissioning and qualification project delivery.  Our unique qualifications include:

  • Knowledge Solutions
    CAI sets the pace for industry leadership, innovative approaches, and real-word application of modern C&Q approaches. We helped “write the book” on ASTM E2500 in more ways than one.  Our experts drove content and creation of this standard, led development of industry guidance documents and training, and are now leading field implementation of these principles.  We have authored and implemented corporate programs on risk based C&Q for several multi-national biopharmaceutical companies.
  • Project Solutions
    Our employee-owners are trained and qualified to deliver to exacting quality standards while managing cost, schedule, and scope. Project managers are formally trained and assessed on their knowledge of our quality standards – an assessment they must pass to manage projects. The result?  High performance and well-trained teams that can hit the ground running, greatly reducing ramp up time and improving quality for your projects. Our team is your fire and forget solution.
  • Performance Solutions
    Our BioVoke electronic Validation Lifecycle Management system drives project efficiency to reduce cost and schedule through effective issues tracking and resolution, document management, protocol generation, and “paper on glass” field execution capability. When you need to meet a higher standard, we are the global provider for companies ranging from discovery start-ups to established multi-national brands.

 

Our Commissioning and Qualification Services

Our clients’ focus is on total life-cycle costs, while meeting the demands of global GMP regulations. We execute on our clients’ objectives, helping to deliver efficient, reliable, GMP-compliant facilities and processes.

Project Cornerstone

GEP Procedures, commissioning specifications, and planning are the keys to project success. We have extensive experience developing verification programs to meet international standards, our clients’ unique requirements, and current best practices. We build project strategies for our clients by incorporating their “way of working” to get the job done efficiently while building and enhancing their C&Q program for future implementation.

Our Process and Concept Design Services

  • Concept design studies
  • Project planning: scheduling, budgeting, reporting
  • Technology transfer planning and project management
  • Regulatory strategy development
  • Commissioning and qualification (C&Q) master planning
  • Process quality risk assessments
  • Operational readiness
  • Owner’s project management
  • ASTM E2500 implementation: strategies for demonstrating equipment suitability

Capital Project Delivery and the Project Anchor Leg

GMP project delivery is a demanding endeavor. Our skilled and well-managed teams, who use proven GMP information management software, are the right choice for your project.

We assure success of our clients’ most complex and large-scale capital projects, as well as small, but critical retrofit/expansion projects. From construction quality assurance to automation systems, we will show you how to meet the most stringent quality, cost, and schedule requirements.

Our Capital Project Delivery Services

  • Design review and qualification
  • FAT/SAT planning and execution support
  • Commissioning protocol development and field execution
  • Facility and process startup support
  • IQ/OQ/PQ protocol development and execution
  • Process validation support
  • Cleaning validation
  • Shipping validation
  • Automation qualification
  • Computer systems validation

Our BioVoke eVLM® Information Management Suite

BioVoke eVLM seamlessly manages and integrates GMP information during project delivery, and during manufacturing operations. Using BioVoke means you can:

  • Deliver projects faster, at lower cost, and with higher, compliant quality
  • Manage GMP information in one centralized location
  • Standardize your project deliver methodologies across world-wide locations