People | Process | Product

Optimize Delivery, Performance, Reliability, and Compliance

Manufacturing high quality products in a GMP environment requires having the right people, training them on a qualified process, and using facilities and equipment suitable for the process. We deliver solutions that meet these requirements: solutions that optimize facility delivery, enhance process performance, improve reliability, and address potential compliance gaps.  Our solutions are flexible for new builds, modifications to existing facilities, or addressing the challenges associated with legacy facilities.

qualification_validation_full

Meeting the Challenge of Global GMP-Regulated Manufacturing

Whether your challenge is rapid delivery of novel life-saving therapies or aggressive cost and schedule pressures when delivering new manufacturing capacity, we drive project success.  When the inevitable challenges arise, we establish risk mitigation and contingency plans to overcome the obstacles.  We drive success by staying focused on project objectives and the “voice of the product.”

The Commissioning Agents Advantage

We are a “category of one” when it comes to commissioning, qualification and validation project delivery.  Our unique qualifications include:

  • Knowledge Solutions

    Commissioning Agents 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 now are 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. We have a robust project execution quality system to manage cost, schedule, scope and quality.  Project managers are formally trained and assessed on their knowledge of our quality system – an assessment they must pass to manage projects.

  • Performance Solutions

    Our BioVoke GMP IT Suite 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 of choice for companies ranging from discovery start-ups to established multi-national brands.

Our Commissioning, Qualification and Validation 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 customer’s unique requirements, and current best practices. We build project strategies for our customers incorporating their ‘way of working’ to get the job done efficiently while building and enhancing their CQV 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, qualification, and validation (CQV) master planning
  • Process quality risk assessments
  • Operational readiness
  • Owner 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, using proven GMP information management software, are the right choice for your project.

We assure success of your most complex and large-scale capital projects, as well as your small but critical retrofit/expansion projects. From construction quality assurance to automation systems, we’ll 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® GMP Information Management Suite

BioVoke® 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

Our Issues and Change Management module alone will yield savings many times its cost, plus schedule savings. Add document management, paperless protocol (tablet) development and execution, and management of product/process knowledge, and you have a powerful suite of GMP information. Managed for your benefit.

Operations and Continuous Improvement

Our clients strive for operational excellence; efficiency, high product yields and low cost of goods sold. Our experience helping clients meet these goals through our unique approach to product and process knowledge, process improvement, and quality systems deployment can be leveraged to enable your success.

The Key to World-Class Manufacturing Operations

We can help you meet your goals by implementing a “right first time” lean approach. We achieve this by understanding the process control strategy; “listening to the voice of the product;” and the customer’s requirements to drive reliable and high quality manufacturing. With this approach we easily meet the challenges of regulatory compliance, supply chain assurance, and production availability.

Our Operational Excellence Services

  • Maintenance and calibration program development
  • SOPs, training, personnel qualification development
  • Quality system implementation
  • Manufacturing process and operations assessments
  • Improvement project development and integration
  • Quality and regulatory compliance audits, remediation, and QP services
  • Implementation of Quality Metrics
  • Implementation of Quality Culture Programs

 

TALK TO US » You’ll find out why we’re a premier name in Engineering Services and realize for yourself the value of working with an industry leader.