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High Performance Teams Make the Difference.




     COMMISSIONING AGENTS, INC. PROFILE
     Commissioning Agents, Inc. (CAI) provides integrated validation, qualification and commissioning
     services for technology intensive capital projects and building construction. Our services include
     validation and commissioning planning, management, and field execution for biotech/pharmaceutical
     manufacturing facilities and laboratories, and Building Commissioning and LEED Cx services for
     educational, healthcare, government and private facilities, and data centers. We also provide regulatory
     compliance consulting, maintenance program development, SOP and training development, and
     computer software development and validation.


     PRODUCING BENEFITS FOR OUR CLIENTS
     We are driven to ensure the owner’s project requirements are met by the delivered equipment and
     facilities. We are specialists in the validation and commissioning profession. It is what we do; it is who
     we are. We understand current industry practices and regulatory expectations for qualification
     documentation and approaches. We are at the forefront of industry improvement efforts (ISPE, ASTM).
     Our people know how equipment must operate to perform as a system, and how systems must
     integrate to meet end-user requirements. Our clients frequently comment on how we, apart from any
     other contractor they have experienced, put their interests first and go the extra mile to help deliver
     their project on target, on budget, and on schedule.


     AT-A-GLANCE
     Founded:                                 1996
     Cumulative services rendered:            $210 million
     2011 sales:                              $35 million

     Full time employees:                     230 (205 Technical Professionals; 6 Administrative)

     Ownership:
                                                                   100% employee-owned through an Over
                                                                   half of the capital is allocated to United
                                                                   States veterans, who comprise more
                                                                   than half of our employees. The vast
                                                                   majority of company management
                                                                   consists of veterans, along with half of
                                                                   the board of directors. Our workforce is
                                                                   distributed throughout the United
                                                                   States and Puerto Rico, as indicated by
                                                                   the map.
High Performance Teams Make the Difference.




     ORGANIZATIONAL CHART
High Performance Teams Make the Difference.




     CORE SERVICES
     Commissioning Agents, Inc. (CAI) provides a variety of commissioning and validation services.
     Furthermore, we specialize in providing services for technologically sophisticated, biotech/
     pharmaceutical manufacturing facilities, healthcare facilities and laboratories.

     COMMISSIONING
     Services include (but are not limited to):
         • Requirements development
         • Planning and schedule development
         • Design and submittal reviews
         • Pre-delivery inspections
         • Factory and site acceptance (FAT/SAT) support
         • Equipment receipt and installation inspections
         • Construction quality oversight/ in-process inspections
         • Execution coordination/ management
         • System start-up/ shakedown / troubleshooting
         • Functional and performance testing
         • System manuals/ turnover packages
         • Warranty reviews
         • Document verification
         • DCS, BAS/ BMS, and PLC Installation Checkout


     VALIDATION
         •   Process validation
         •   Cleaning validation
         •   Sterilization validation
         •   Master plans
                                                          PRODUCTION SUPPORT
                                                              •   Maintenance and calibration programs
     QUALIFICATION                                            •   SOP development
         •   Protocol execution                               •   Training
         •   Automation validation                            •   Risk assessments
         •   Facilities, utilities, process equipment         •   Process efficiency studies
         •   IQ/OQ/PQ protocol development                    •   cGMP compliance audits, improvement
         •   Final reports                                        and remediation support
         •   IT systems validation                            •   Process analytical technology
         •   Lab equipment                                        implementation
High Performance Teams Make the Difference.




     BUILDING CX SERVICES
     INDEPENDENT OBJECTIVITY
     Commissioning is our core competency. We work in cooperation with
     architects and engineers, Client Managers and other team members
     involved in a project to ensure specifications are met, keeping projects
     on schedule. We have excelled as a technically competent, independent
     commissioning authority for over 14 years. Commissioning Agents has
     provided over $160 million in technical services, and have been engaged
     in over 1800 separate projects. We implement our “whatever it takes”
     work ethic to every project to ensure successful completion.
                                                                                    Our Services Include:
                                                                                    •   Commissioning Planning
     COMPREHENSIVE SERVICES                                                         •   Design Review
     Our comprehensive services include all aspects of commissioning for            •   Protocol Development
     new and existing buildings, manufacturing and health care facilities,          •   Construction Quality Assurance
                                                                                    •   Commissioning & Start-Up
     power plants and other projects requiring assurance that construction
                                                                                    •   Project Delivery Management
     and performance specifications are met. Whether a project involves
                                                                                    •   Instrumentation
     getting a new facility in operation, adding a piece of equipment or retro-
     commissioning an existing building, Commissioning Agents, Inc. provides
     a comprehensive set of essential services to complete your project.            Meeting Expectations:
                                                                                    “Your employees worked long hours,
                                                                                    demonstrated excellent teamwork and
                                                                                    communicated effectively with all team
     HIGH PERFORMANCE TEAMS                                                         members to get the work done. Above
     It is critical to have a well-oiled, efficient team of professionals who are   all, they are great to work with and we
     familiar with our procedures, each other and the work requirements. All        certainly look forward to working with
     of our employees are full-time, permanent workers – not contract               CAI again in the near future.”
     employees thrown into an unfamiliar situation. As a result we provide
     clients with a highly effective performance team. For each specific
     project we field a specialized team with appropriate core competencies.
     Our staff includes professionals with diverse skills.



     TAILORED SOLUTIONS
     Each project has different requirements based on the technical
     complexity and owner’s requirements. We tailor our level of service to
     the nature and needs of each project to ensure the owner receives a
     fully-functional facility.
High Performance Teams Make the Difference.




     INDUSTRY SEGMENTS
     Commissioning Agents, Inc. serves Fortune 500 companies (and some that will be in the future). Our
     clients include some of the largest pharmaceutical companies in the world. We also serve smaller
     companies and start-ups that are ready to launch their first product. Due to our performance and high
     degree of customer satisfaction, more than 90% of our business is from repeat clients.



     GMP QUALIFICATION/VALIDATION
         •   Pharmaceutical
         •   Biotechnology
         •   Medical Devices
         •   Combination Products



     GMP COMPLIANCE & PRODUCTION SUPPORT
         •   Pharmaceutical
         •   Biotechnology
         •   Medical Device
         •   Combination Products
         •   Food manufacturing
         •   Cosmetic manufacturing



     COMMISSIONING
         •   Educational Facilities
         •   Health Care Facilities
         •   Pharmaceutical
         •   Biotechnology
         •   Medical Device
         •   Semiconductor Facilities
         •   Combination Products
         •   Commercial Buildings/ Facilities
         •   Power Generation Facilities
         •   Process (chemical) Manufacturing Industries
         •   Fabrication/ Assembly Manufacturing Industries
High Performance Teams Make the Difference.




     OUR COMMITMENT TO QUALITY
     Commissioning Agents, Inc. has developed a program of skill and knowledge based qualification and
     continuing education at industry conferences and training courses. This instruction enhances staff
     confidence, allowing them to work capably on a wider variety of project assignments and increasing job
     and personal satisfaction. Completing this competency development program also allows our staff to
     provide extra value to projects. In short, we don’t just apply “bodies” to a project – we apply capable
     people who will add value to your project team from day one.

     Our Qualification Program has the following levels:




     Tier I/II: Basic knowledge of industry and core services. Consists of oral check-outs and written final
     examination. 6 months to complete.

     Tier III Project Management Administration: Knowledge of procedures for managing a project, including
     basic scheduling and earned value. Consists of oral check-outs and written final examination.

     Tier III Technical: Consists of oral check-outs, required reading, required training course attendance, a
     project experience (varies from 1200 – 4000 hours). Final written examination.

     Tier IV: Customized program of advanced capabilities.
High Performance Teams Make the Difference.




     THE COMMISSIONING AGENTS, INC. CULTURE
     Commissioning Agents, Inc. invites only top candidates to join our team. We provide them with
     challenging assignments, and encourage professional development and growth. This formula for
     retaining capable and highly motivated people has proven successful.

     Our staff comes from a variety of backgrounds. More than half of the staff served in the Navy as a
     nuclear-trained officer or technical specialist. As a result of this training we understand how to develop
     and use written procedures for testing, maintenance, and operations, and have integrity and a solid
     work ethic that allows us to learn new equipment and systems quickly.

     During commissioning work we utilize our experience to identify aspects of the installation or
     operation that may not be part of the protocol, but could cause operational issues later.
     Commissioning Agents is proactive in troubleshooting to correct issues in concert with the vendor or
     construction manager. We also have several key people with over 20 years working for
     pharmaceutical manufacturers in validation and quality assurance positions.


     DIFERENTIATING OURSELVES
     Our customers tell us we stand apart from other contractors for two reasons:

         1. We help fix and, more importantly, drive issues to completion. We will attempt to foresee and
            minimize and/or avoid road-blocks to get problems retested properly, with documentation, to
            meet expectations.

         2. We do what is in the customer’s best interest, even when it may not be in our best interest.

     Our internal quality system will ensure that our deliverables are professional and free from
     grammatical, spelling and document formatting errors prior to submittal.

     Our field quality program delivery method addresses all issues in a 3-tier solution to drive issues to
     immediate resolution. This program works as a cooperative team with our client, engineers and
     contractors. Moreover, we will consider schedule, client requirements and project costs while keeping
     an eye on the targeted results.
High Performance Teams Make the Difference.




     EARNING A SOLID REPUTATION
     Customers routinely provide us with unsolicited, positive feedback on the performance of our teams
     because we remove hurdles and roadblocks while others wait for them to be removed. We facilitate
     progress, while others are busy documenting why they can’t make progress.

     Some of this feedback includes:
     "There were numerous contractors (i.e., no one company had total responsibility) and you (CAI) were
     able to get them all to work as a team with a common goal. Your team leader stepped into a very
     difficult position as the C & Q lead of a very dysfunctional team. He was able to calm the "noise" and get
     the team focused on execution. The Commissioning & Q/CSV program was well integrated and quite
     successful.”

     “We have been very impressed with CAI’s commitment to getting the job done with your ‘whatever it
     takes’ attitude.”

     “After working with various commissioning/ qualification contractors, my experiences with CAI have
     been the most effective and rewarding. With past contractors, I have been the one to educate their
     team. It has been a relief to receive an education from the validation experts.”

     “I have had the opportunity in my seven years as department manager to have worked with numerous
     other contract services organizations; by far, Commissioning Agents proved the best value to me and my
     company.”


     CREATING CUSTOMER SATISFACTION
     Commissioning Agents, Inc wants to partner with you on future projects. We strive to elicit a positive
     reaction about our work from each and every client. Because of our reputation, dedication, and unique
     way of training and fielding a high performance team, we are your best choice to partner with for the
     successful completion of projects. We are awarded nearly 90 percent of work requested from repeat
     customers, and we look forward to the opportunity to earn additional repeat customers.
High Performance Teams Make the Difference.




     STRONG PERFORMANCE = SOLID GROWTH
     PREMIER PROVIDER
     Commissioning/Validation is our primary line of work. We are currently engaged as either the sole or
     lead commissioning contractor at 10 major projects, for 5 different Fortune 500 companies. The capital
     budgets for these major projects exceed $2 billion, with the commissioning service contracts totaling
                                                                                       more than $20 million.

                                                                                          With current annual
                                                                                          sales of nearly $28
                                                                                          million, we have the
                                                                                          skilled resources and
                                                                                          financial strength to
                                                                                          tackle a wide range of
                                                                                          projects: any size, in
                                                                                          any location around
                                                                                          the world.


                                                                                          GROWTH
                                                                                          STRATEGY
                                                                                           We grow only as fast
                                                                                           as we can hire top
                                                                                           quality people, and
                                                                                           properly train and
                                                                                           assimilate them into
                                                                                           our project teams.
     Some of our competition will provide an experience project manager and one or two current
     employees, and then hire the remainder of the team. We believe this strategy does not serve a client’s
     best interest, even when it results in a team of mostly local people. In our line of work, we believe it is
     critical to have a well-oiled, efficient team of people, most of whom are familiar with each other and
     with the work requirements. Hence, we provide 70 – 90% of any project team from our current staff.

     We carefully select the projects we accept to ensure we meet our commitments and provide a positive
     project experience. Our growth occurs as a result of exceeding client expectations, which lead to more
     and larger projects. Commissioning Agents, Inc.’s reputation is spreading, leading to new business
     opportunities, which we translate into professional growth opportunities for our people.

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CAI Firm Overview

  • 1. High Performance Teams Make the Difference. COMMISSIONING AGENTS, INC. PROFILE Commissioning Agents, Inc. (CAI) provides integrated validation, qualification and commissioning services for technology intensive capital projects and building construction. Our services include validation and commissioning planning, management, and field execution for biotech/pharmaceutical manufacturing facilities and laboratories, and Building Commissioning and LEED Cx services for educational, healthcare, government and private facilities, and data centers. We also provide regulatory compliance consulting, maintenance program development, SOP and training development, and computer software development and validation. PRODUCING BENEFITS FOR OUR CLIENTS We are driven to ensure the owner’s project requirements are met by the delivered equipment and facilities. We are specialists in the validation and commissioning profession. It is what we do; it is who we are. We understand current industry practices and regulatory expectations for qualification documentation and approaches. We are at the forefront of industry improvement efforts (ISPE, ASTM). Our people know how equipment must operate to perform as a system, and how systems must integrate to meet end-user requirements. Our clients frequently comment on how we, apart from any other contractor they have experienced, put their interests first and go the extra mile to help deliver their project on target, on budget, and on schedule. AT-A-GLANCE Founded: 1996 Cumulative services rendered: $210 million 2011 sales: $35 million Full time employees: 230 (205 Technical Professionals; 6 Administrative) Ownership: 100% employee-owned through an Over half of the capital is allocated to United States veterans, who comprise more than half of our employees. The vast majority of company management consists of veterans, along with half of the board of directors. Our workforce is distributed throughout the United States and Puerto Rico, as indicated by the map.
  • 2. High Performance Teams Make the Difference. ORGANIZATIONAL CHART
  • 3. High Performance Teams Make the Difference. CORE SERVICES Commissioning Agents, Inc. (CAI) provides a variety of commissioning and validation services. Furthermore, we specialize in providing services for technologically sophisticated, biotech/ pharmaceutical manufacturing facilities, healthcare facilities and laboratories. COMMISSIONING Services include (but are not limited to): • Requirements development • Planning and schedule development • Design and submittal reviews • Pre-delivery inspections • Factory and site acceptance (FAT/SAT) support • Equipment receipt and installation inspections • Construction quality oversight/ in-process inspections • Execution coordination/ management • System start-up/ shakedown / troubleshooting • Functional and performance testing • System manuals/ turnover packages • Warranty reviews • Document verification • DCS, BAS/ BMS, and PLC Installation Checkout VALIDATION • Process validation • Cleaning validation • Sterilization validation • Master plans PRODUCTION SUPPORT • Maintenance and calibration programs QUALIFICATION • SOP development • Protocol execution • Training • Automation validation • Risk assessments • Facilities, utilities, process equipment • Process efficiency studies • IQ/OQ/PQ protocol development • cGMP compliance audits, improvement • Final reports and remediation support • IT systems validation • Process analytical technology • Lab equipment implementation
  • 4. High Performance Teams Make the Difference. BUILDING CX SERVICES INDEPENDENT OBJECTIVITY Commissioning is our core competency. We work in cooperation with architects and engineers, Client Managers and other team members involved in a project to ensure specifications are met, keeping projects on schedule. We have excelled as a technically competent, independent commissioning authority for over 14 years. Commissioning Agents has provided over $160 million in technical services, and have been engaged in over 1800 separate projects. We implement our “whatever it takes” work ethic to every project to ensure successful completion. Our Services Include: • Commissioning Planning COMPREHENSIVE SERVICES • Design Review Our comprehensive services include all aspects of commissioning for • Protocol Development new and existing buildings, manufacturing and health care facilities, • Construction Quality Assurance • Commissioning & Start-Up power plants and other projects requiring assurance that construction • Project Delivery Management and performance specifications are met. Whether a project involves • Instrumentation getting a new facility in operation, adding a piece of equipment or retro- commissioning an existing building, Commissioning Agents, Inc. provides a comprehensive set of essential services to complete your project. Meeting Expectations: “Your employees worked long hours, demonstrated excellent teamwork and communicated effectively with all team HIGH PERFORMANCE TEAMS members to get the work done. Above It is critical to have a well-oiled, efficient team of professionals who are all, they are great to work with and we familiar with our procedures, each other and the work requirements. All certainly look forward to working with of our employees are full-time, permanent workers – not contract CAI again in the near future.” employees thrown into an unfamiliar situation. As a result we provide clients with a highly effective performance team. For each specific project we field a specialized team with appropriate core competencies. Our staff includes professionals with diverse skills. TAILORED SOLUTIONS Each project has different requirements based on the technical complexity and owner’s requirements. We tailor our level of service to the nature and needs of each project to ensure the owner receives a fully-functional facility.
  • 5. High Performance Teams Make the Difference. INDUSTRY SEGMENTS Commissioning Agents, Inc. serves Fortune 500 companies (and some that will be in the future). Our clients include some of the largest pharmaceutical companies in the world. We also serve smaller companies and start-ups that are ready to launch their first product. Due to our performance and high degree of customer satisfaction, more than 90% of our business is from repeat clients. GMP QUALIFICATION/VALIDATION • Pharmaceutical • Biotechnology • Medical Devices • Combination Products GMP COMPLIANCE & PRODUCTION SUPPORT • Pharmaceutical • Biotechnology • Medical Device • Combination Products • Food manufacturing • Cosmetic manufacturing COMMISSIONING • Educational Facilities • Health Care Facilities • Pharmaceutical • Biotechnology • Medical Device • Semiconductor Facilities • Combination Products • Commercial Buildings/ Facilities • Power Generation Facilities • Process (chemical) Manufacturing Industries • Fabrication/ Assembly Manufacturing Industries
  • 6. High Performance Teams Make the Difference. OUR COMMITMENT TO QUALITY Commissioning Agents, Inc. has developed a program of skill and knowledge based qualification and continuing education at industry conferences and training courses. This instruction enhances staff confidence, allowing them to work capably on a wider variety of project assignments and increasing job and personal satisfaction. Completing this competency development program also allows our staff to provide extra value to projects. In short, we don’t just apply “bodies” to a project – we apply capable people who will add value to your project team from day one. Our Qualification Program has the following levels: Tier I/II: Basic knowledge of industry and core services. Consists of oral check-outs and written final examination. 6 months to complete. Tier III Project Management Administration: Knowledge of procedures for managing a project, including basic scheduling and earned value. Consists of oral check-outs and written final examination. Tier III Technical: Consists of oral check-outs, required reading, required training course attendance, a project experience (varies from 1200 – 4000 hours). Final written examination. Tier IV: Customized program of advanced capabilities.
  • 7. High Performance Teams Make the Difference. THE COMMISSIONING AGENTS, INC. CULTURE Commissioning Agents, Inc. invites only top candidates to join our team. We provide them with challenging assignments, and encourage professional development and growth. This formula for retaining capable and highly motivated people has proven successful. Our staff comes from a variety of backgrounds. More than half of the staff served in the Navy as a nuclear-trained officer or technical specialist. As a result of this training we understand how to develop and use written procedures for testing, maintenance, and operations, and have integrity and a solid work ethic that allows us to learn new equipment and systems quickly. During commissioning work we utilize our experience to identify aspects of the installation or operation that may not be part of the protocol, but could cause operational issues later. Commissioning Agents is proactive in troubleshooting to correct issues in concert with the vendor or construction manager. We also have several key people with over 20 years working for pharmaceutical manufacturers in validation and quality assurance positions. DIFERENTIATING OURSELVES Our customers tell us we stand apart from other contractors for two reasons: 1. We help fix and, more importantly, drive issues to completion. We will attempt to foresee and minimize and/or avoid road-blocks to get problems retested properly, with documentation, to meet expectations. 2. We do what is in the customer’s best interest, even when it may not be in our best interest. Our internal quality system will ensure that our deliverables are professional and free from grammatical, spelling and document formatting errors prior to submittal. Our field quality program delivery method addresses all issues in a 3-tier solution to drive issues to immediate resolution. This program works as a cooperative team with our client, engineers and contractors. Moreover, we will consider schedule, client requirements and project costs while keeping an eye on the targeted results.
  • 8. High Performance Teams Make the Difference. EARNING A SOLID REPUTATION Customers routinely provide us with unsolicited, positive feedback on the performance of our teams because we remove hurdles and roadblocks while others wait for them to be removed. We facilitate progress, while others are busy documenting why they can’t make progress. Some of this feedback includes: "There were numerous contractors (i.e., no one company had total responsibility) and you (CAI) were able to get them all to work as a team with a common goal. Your team leader stepped into a very difficult position as the C & Q lead of a very dysfunctional team. He was able to calm the "noise" and get the team focused on execution. The Commissioning & Q/CSV program was well integrated and quite successful.” “We have been very impressed with CAI’s commitment to getting the job done with your ‘whatever it takes’ attitude.” “After working with various commissioning/ qualification contractors, my experiences with CAI have been the most effective and rewarding. With past contractors, I have been the one to educate their team. It has been a relief to receive an education from the validation experts.” “I have had the opportunity in my seven years as department manager to have worked with numerous other contract services organizations; by far, Commissioning Agents proved the best value to me and my company.” CREATING CUSTOMER SATISFACTION Commissioning Agents, Inc wants to partner with you on future projects. We strive to elicit a positive reaction about our work from each and every client. Because of our reputation, dedication, and unique way of training and fielding a high performance team, we are your best choice to partner with for the successful completion of projects. We are awarded nearly 90 percent of work requested from repeat customers, and we look forward to the opportunity to earn additional repeat customers.
  • 9. High Performance Teams Make the Difference. STRONG PERFORMANCE = SOLID GROWTH PREMIER PROVIDER Commissioning/Validation is our primary line of work. We are currently engaged as either the sole or lead commissioning contractor at 10 major projects, for 5 different Fortune 500 companies. The capital budgets for these major projects exceed $2 billion, with the commissioning service contracts totaling more than $20 million. With current annual sales of nearly $28 million, we have the skilled resources and financial strength to tackle a wide range of projects: any size, in any location around the world. GROWTH STRATEGY We grow only as fast as we can hire top quality people, and properly train and assimilate them into our project teams. Some of our competition will provide an experience project manager and one or two current employees, and then hire the remainder of the team. We believe this strategy does not serve a client’s best interest, even when it results in a team of mostly local people. In our line of work, we believe it is critical to have a well-oiled, efficient team of people, most of whom are familiar with each other and with the work requirements. Hence, we provide 70 – 90% of any project team from our current staff. We carefully select the projects we accept to ensure we meet our commitments and provide a positive project experience. Our growth occurs as a result of exceeding client expectations, which lead to more and larger projects. Commissioning Agents, Inc.’s reputation is spreading, leading to new business opportunities, which we translate into professional growth opportunities for our people.