cai company profile as 06-05-14

Commissioning Agents, Inc. Corporate Office Commissioning Agents Puerto Rico, LLC PO Box 34320 Indianapolis, IN 46234

Phone: Fax:

317.271.6082317.271.6097

District View Plaza644 Fernández Juncos Avenue San Juan, Puerto Rico 00907‐3122

Phone: Fax:

787.469.6209787.919.7323 787.919.7319

STATEMENT OF CAPABILITIES

Delivering Global Expertise.


Phone: Fax:

317.271.6082317.271.6097


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787.469.6209787.919.7323 787.919.7319

Statement of Capabilities

Commissioning Agents, Inc.

Commissioning Agents capabilities have depth, strength, and are far reaching. Commissioning Agents,

Inc. is pleased to provide knowledgeable, high‐performance teams, or individuals, as best meets the

needs of your projects. We have extensive experience in the design, commissioning, qualification, and

validation of many different types of facilities, dosage forms, the associated equipment and processes.

In addition, we have extensive experience with assisting our clients in regulatory compliance.

Commissioning Agents also provides building commissioning and consulting services, including ASHRAE,

LEED® Fundamental EAp1 and Enhanced Commissioning EAc3 for LEED®, Total Building Commissioning,

Inspections and Mechanical‐Electrical‐Plumbing (MEP) systems verification. We have worked in

healthcare, laboratory, educational, pharmaceutical, public and private facilities as well.

Commissioning Agents has over 230 technical staff members, including 20 employees local to Puerto

Rico. We typically work on a scope of work basis, whereby we work with clients to define a scope of

work, budget, schedule and management plan to complete the work.

Attached is a statement of our capabilities.

Yours very truly,

Eddie RF Cordoves, BSIE ‐ MBA PR Director of Operations Mobile: 787.466.6099


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317.271.6082317.271.6097


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Our Sole Purpose is to Drive Projects to Successful Completion

Providing Knowledge Solutions Meeting Regulations and Improving Your Bottom Line

Project Solutions Meeting Schedule, Budget and Deliverables

Performance Solutions Motivated People Going the Extra Mile;

Putting Your Interests First

Our value proposition is that each project needs three core ingredients to succeed:

Knowledgeable staff that are trained and experienced in the role that they are executing. Commissioning Agents consultants experience in terms of compliance goes far beyond the maintenance of the operational state. Our consultants have the working knowledge and have been involved with confirming conceptual design, design, installation, operation, and finally manufacturing of commercial product (maintenance of the validated state). We have the depth of knowledge to provide our clients with not only a compliant solution, but one that is practical and implementable.

A Project Focused Approach that delivers real advice for the client. This means not just identifying problems, but proposing practical solutions. For compliance auditing; each of the audits/inspections our consultants performed, results in a formal detailed report. The report states the documents reviewed, areas observed, the regulation, observations (ranked in order of probability of an observation from a regulatory body), and proposed corrective actions.

Our staffs are permanent employees and shareholders of the organization. They are motivated to work hard and provide High Performance Solutions for our valued clients as we know that this leads to a reputation for excellence and future business.

We Create Value… Well‐Defined Projects and Honest Estimates of Budget and Schedule

Qualified Personnel – or We Don’t Bid!

Formal Qualification Program

On‐Going Professional Development Program

Team‐Based Solutions Managed as a Project

Partnering with the Best


Phone: Fax:

317.271.6082317.271.6097


Phone: Fax:

787.469.6209787.919.7323 787.919.7319



Success Is... Meeting Tasking On Time, Within Budget

Efficiently Staffing Projects

Providing Professionally Challenging and Satisfying Projects for Our Agents

Commissioning Agents, Inc. Profile Commissioning Agents, Inc. (CAI) provides integrated validation, qualification and commissioning

services for technology intensive capital projects, new building construction, planned facility and process

renovation, and those unplanned renovations mandated by a regulatory body.

Our services include validation and commissioning planning, management, and field execution for Over

the Counter, Oral Solid Dosages, Pharmaceutical manufacturing facilities (Biotech and Drug), and

laboratories. We also provide regulatory services, compliance consulting, compliance and supply chain

auditing, maintenance program development, SOP and training development, and computer software

development and validation. We offer these services as a Scope of Work and or Staff Augmentation.

We also provide regulatory compliance consulting, maintenance program development, Procedure

preparation (SOP, specifications, batch records, etc.) and training development and delivery, and

computer software development and validation. Our staff has worked in the industry and the armed

forces. They understand what it means to deliver and how important it is to get product to the patient.

We have the certified engineers to perform Building Commissioning and LEED® Cx services for

educational, healthcare, government, private facilities and data centers.

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 commissioning,

qualification, documentation, and standard and novel compliant approaches. We are at the forefront of

industry improvement efforts (ICH, ISPE, ASTM, PDA). Our people know the intricacies of how

equipment should be installed and started up. We know how equipment must operate to perform as a

system, and how systems must be integrated and tested 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.

We do not stop when we encounter an issue; we trouble shoot the problem; we fix the problem and we

continue!


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317.271.6082317.271.6097


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Commissioning Agents, Inc. is committed to providing the best staff for each of our projects and clients.

Each employee is personally responsible for their professional development and staying current with

regulations and industry practices. Each year, we include over 60 professional development hours for

each person into our budget; employees must submit a professional development plan indicating how

they intend to use those hours. Our Director of Professional Development advises staff on

accomplishing their plan, which includes short courses, seminars and other training opportunities, using

the expertise of both internal and external subject matter experts. Our consultants attend conferences

across the world, staying up to date. Additionally, our consultants provide industry and regulators with

new concepts by making presentations at conferences (domestically and internationally) for Parenteral

Drug Association (PDA) and International Society of Pharmaceutical Engineering (ISPE), American Society

of Quality (ASQ), and other professional organizations.

Companies hire Commissioning Agents to:

Plan their projects,

to review their facility and equipment design to confirm compliance,

to lead their teams (internal and external),

to troubleshoot issues and solve problems,

to verify the facility and systems are tested and testing is well documented,

and to confirm readiness for regulatory inspections / production / manufacturing

High Performance Teams It is critical to have a well‐oiled, efficient team of professionals who are familiar with our procedures,

each other, and the work requirements. All of our employees are full‐time, permanent workers – not

contract 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 compliant facility.


Phone: Fax:

317.271.6082317.271.6097


Phone: Fax:

787.469.6209787.919.7323 787.919.7319



Commissioning Agents AtAGlance

Founded: 1996

Cumulative Services Rendered: $210 million

2012 Sales: Approximately $45 million

Full Time Employees: 315 (308 Technical Professionals; 7 Administrative) Ownership: 100% employee‐owned through an employee stock ownership plan (ESOP). 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.


Phone: Fax:

317.271.6082317.271.6097


Phone: Fax:

787.469.6209787.919.7323 787.919.7319



Organizational Chart


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317.271.6082317.271.6097


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787.469.6209787.919.7323 787.919.7319



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

THERMAL MAPPING / COLD SPOT DETERMINATION

SYSTEM MANUALS/ TURNOVER PACKAGES

WARRANTY REVIEWS

DOCUMENT VERIFICATION

DCS, BAS/ BMS, AND PLC INSTALLATION CHECKOUT

Validation Production Support PROCESS VALIDATION TRAINING

CLEANING VALIDATION RISK ASSESSMENTS

STERILIZATION VALIDATION PROCESS EFFICIENCY STUDIES

MASTER PLANS

PROTOCOL EXECUTION

AUTOMATION VALIDATION

CGMP COMPLIANCE AUDITS, IMPROVEMENT AND

REMEDIATION SUPPORT

PROCESS ANALYTICAL TECHNOLOGY IMPLEMENTATION

LAB EQUIPMENT

AUTOMATION VALIDATION

FACILITIES, UTILITIES, PROCESS EQUIPMENT

IQ/OQ/PQ PROTOCOL DEVELOPMENT

FINAL REPORTS

IT SYSTEMS VALIDATION


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317.271.6082317.271.6097


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787.469.6209787.919.7323 787.919.7319



Process Validation Commissioning Agents consultants have the industry experience and regulatory knowledge to provide

our clients with an approach to process validation that will meet most agencies expectations. We have

defined Process Validation requirements for drug, biological, medical devices, oral solid dosages and

over the counter medicines. As Process Validation is defined as the collection and evaluation of data,

from the process design stage throughout production, Commissioning Agents will require access to the

product development data. This data is required so that the target process parameters, target hold

time, container closure, and critical product attributes can be included in the process validation strategy.

The process validation testing will establish evidence that the CSL Behring processes are capable of

consistently delivering quality products and will generate data support their submission. Our approach

would be based on the following references, which represent current industry approaches and

philosophies for validation:

ICH Q8/ Q8(R2), Pharmaceutical Development

ICH Q9, Quality Risk Management

ICH Q10, Pharmaceutical Quality System

US FDA, Process Validation: General Principles and Practices (January 2011)

ASTM E2500, Standard Guide for Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

ICH Q2A and Q2B, Validation of Analytical Procedures

Collectively, these references describe an approach to pharmaceutical development, risk management,

and quality systems that is based on understanding the product and process science (critical quality

attributes and critical process parameters), managing risks to the patient, and a systems approach to

quality management. These principles can be directly applied to qualification and validation.

The US FDA process validation guidance update essentially re‐characterizes validation as a three‐stage

life‐cycle process. Quoting from the guidance:

Stage 1 – Process Design: The commercial process is defined during this stage based on

knowledge gained through development and scale‐up activities.

Stage 2 – Process Qualification: During this stage, the process design is confirmed as being

capable of reproducible commercial manufacturing.

Stage 3 – Continued Process Verification: Ongoing assurance is gained during routine

production that the process remains in a state of control.


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317.271.6082317.271.6097


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While industry is only beginning to respond to these new initiatives found in the FDA Process Validation

guidance, as well as ICH Q8/9/10, there is significant push from regulators. We therefore suggest that a

forward‐looking validation program be based on these key documents and principles.

Project Management For every project we strive to deliver the defined scope of work within budget and on schedule. To

achieve this goal we designate a qualified project manager to establish project procedures and execute

our internal quality system. Additionally, we conduct a formal project kick off meeting with verify

understanding of the necessary requirements for each aspect of the scope of work. All CAI project

managers have a support structure in place, including a client manager, regional manager, business area

lead and senior company management.

Commissioning and Validation Strategy Focusing on intelligent quality assurance throughout the project life cycle ultimately saves time and

money. There does not need to be a trade‐off between cost, schedule, and quality. We make this

assertion based on the converse: if quality is not a concern, then validation may take longer and

increase costs. If the facility does not meet the end‐user requirements, then life cycle operations and

maintenance costs may be higher.

Intelligent Quality Assurance Intelligent quality assurance is an approach to ensuring the fitness for use of the facility, utilities, and

process equipment that is based on risks:

Risks to the patient

Risks to the manufacturing process

Risks to the project cost and schedule

Risks to the operations

Risks to the patient are based on scientific understanding of the design space. Risks to the

manufacturing process are based on process understanding, experience with the technology, equipment

reliability and other factors. Additional risks are based on design complexity, novelty, vendor and

contractor capabilities, training and experience of the operations staff, etc.

Intelligent quality assurance is a team‐based approach that begins with planning, and requires a high

level of project management acumen and attention to detail. Implementing intelligent quality assurance

includes determining the optimum points in the project delivery process to inspect or test a particular

item, at an appropriate degree of rigor, based on the risks to quality and the project.


Phone: Fax:

317.271.6082317.271.6097


Phone: Fax:

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ASTM E2500 details one approach to implementing intelligent quality assurance. Commissioning

Agents, Inc. personnel were instrumental in the creation of this international consensus standard.

Quality System Review and Support We offer Regulatory and Compliance Services for FDA and international regulated industries. We have

experienced consultants who can help you establish you compliance and quality systems as well as

resolve your compliance issues quickly and efficiently. We can help you with all aspects of compliance

by offering services such as:

GMP Compliance: compliance audits, compliance action plans and response to inspection citations and warning letters, and implementation of quality systems. We have the experience with hosting the FDA and other regulatory bodies during audits.

New facilities preparation: provide compliance expertise during the design phase, perform design review and help present design to the FDA

Preparation for regulatory inspections: perform mock‐inspections followed by preparation for inspections and by implementation of action plans to address deficiencies and regulatory risk

Quality Assurance services: support QA department in all quality unit responsibilities

Regulatory filing preparation and/or review: preparation, QA and GMP compliance review of regulatory filings

ICH Q10 Quality System implementation

Performed Gap Assessments and associated remediation

Defined and established appropriately sized Quality Systems

Acted as the owner in a staff augmentation type position of Quality/Compliance

Managed customer and vendor complaints and resolutions, resulting CAPAs, and quality system audits.

Managed systems quality inspections/verifications for release systems to customers.

“Commissioning Agents was key to improving our operations and compliance after we received an FDA

Warning Letter. They didn’t just tell us what was wrong; they helped us implement practical compliance

solutions. Upon re‐inspection, the warning letter was lifted and there were no 483 observations.”

Our industry‐experienced compliance consultants help you develop effective and workable compliance

strategies, plans, and procedures — those that will be used!

We understand the current directions in compliance, which include new approaches to manufacturing

quality assurance: a quality systems approach (ICH Q10) that uses quality risk management principles

(ICH Q9), grounded on a solid understanding of the process and product based on development studies

(ICH Q8) and continuous improvement strategies, which use Process Analytical Technology – PAT (in

accordance with FDA guidance on PAT). We have a thorough understanding of the requirements for the


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317.271.6082317.271.6097


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manufacture of starting materials as defined in (ICH Q7), Guide for Active Pharmaceutical Ingredients.

The implementation of 21CFR820 is not just for medical device companies, it is used in addition with the

guidance for Industry “Quality Systems” and ISO 13485. We understand the principles, implementation

details, and how these four documents interrelate to provide a comprehensive, science‐ and risk‐based

manufacturing quality system. Intelligent quality assurance is a team‐based approach that begins with

planning, and requires a high level of project management acumen and attention to detail.

Implementing intelligent quality assurance includes determining the optimum points in the project

delivery process to inspect or test a particular item, at an appropriate degree of rigor, based on the risks

to quality and the project.

ASTM E2500 details one approach to implementing intelligent quality assurance. Commissioning

Agents, Inc. personnel were instrumental in the creation of this international consensus standard.

Integrated Commissioning and Qualification Companies struggle with attempting to integrate commissioning and qualification. The goal is to

eliminate duplication of effort – but how do you prevent commissioning from become de facto

qualification, subject to potentially costly and time‐consuming “rules of the road?”

To successfully integrate commissioning and qualification, the scope of qualification must be isolated to

ONLY those aspects of systems – features, functions, components – that affect product quality. This can

be accomplished using methods such as a system and component impact assessment per the ISPE

Commissioning and Qualification Baseline Guide, a risk assessment process such as a top‐down hazards

analysis, or a FMECA. Once those critical‐to‐quality items have been identified, they become the focus

of qualification.

A robust commissioning process that is planned, managed and documented must be established by the

project team. This ensures the equipment, systems, and facility meet engineering specifications to an

acceptable degree. It also can provide the operating training, procedures, and maintenance program

input necessary to operate, maintain and change the plant per GMPs. Given a vigorous, documented

commissioning program, the qualification protocols can be executed simply by auditing the

commissioning work to confirm the critical‐to‐quality items were satisfactorily verified. A final report is

issued to indicate the given equipment or system is fit for its intended purpose, thereby meeting GMP

regulations. The quality unit is involved in the planning, process requirements, risk or impact

assessments, oversight of execution, and approval of the final report. Subject matter experts are used

to determine how to inspect or test a given engineered item, as well as reviewing the results. Quality

reviews discrepancies that involve critical‐to‐quality items.


Phone: Fax:

317.271.6082317.271.6097


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Project Management For every project we strive to deliver the defined scope of work within budget and on schedule. To

achieve this goal we designate a qualified project manager to establish project procedures and execute

our internal quality system. Additionally, we conduct a formal project kick off meeting with verify

understanding of the necessary requirements for each aspect of the scope of work. All CAI project

managers have a support structure in place, including a client manager, regional manager, business area

lead and senior company management.

Risk Management CAI is well versed in the use of risk management in the equipment validation lifecycle. We can provide a

level and type of risk management that is appropriate for your product and business processes, and one

that fits your organization. Intelligent quality assurance is an approach to ensuring the fitness for use of

the facility, utilities, and process equipment that is based on risks:

Risks to the patient

Risks to the manufacturing process

Risks to the project cost and schedule

Risks to the operations

Risks to the patient are based on scientific understanding of the design space. Risks to the

manufacturing process are based on process understanding, experience with the technology, equipment

reliability and other factors. Additional risks are based on design complexity, novelty, vendor and

contractor capabilities, training and experience of the operations staff, etc.

Equipment Lifecycle Support Directed internal and contract personnel in creation of complete GMP/GAMP5 life cycle documentation.

Created guiding quality policy and standard operating procedures for automated equipment and systems design, implementation, and commissioning/qualification.

Implementation and validation of computer‐controlled, Part 11 compliant, automated fluid bed dryer/granulators, and associated equipment.

Modification and re‐qualification of drying ovens with volatiles management system.

Process capability studies for PAT implementation of encapsulation process control by computer controlled on‐board equipment weight measurement and statistical process control capabilities of an advanced encapsulation system.

Change control/modifications of qualified USP water system

Qualified equipment change control/modifications for use with highly acidic/corrosive drug formulations.


Phone: Fax:

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Phone: Fax:

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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.

Comprehensive Services Our comprehensive services include all aspects of commissioning for new

and existing buildings, manufacturing and health care facilities, power

plants and other projects requiring assurance that construction and

performance specifications are met. Whether a project involves 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.

High Performance Teams It is critical to have a well‐oiled, efficient team of professionals who are

familiar with our procedures, each other and the work requirements. All of

our employees are full‐time, permanent workers – not contract 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.

Our Services Include:

Commissioning Planning

Design Review

Protocol Development

Construction Quality Assurance

Commissioning & Start‐Up

Project Delivery Management

Instrumentation

Meeting Expectations:

“Your employees worked long

hours, demonstrated excellent

teamwork and communicated

effectively with all team

members to get the work done.

Above all, they are great to work

with and we certainly look

forward to working with CAI

again in the near future.”


Phone: Fax:

317.271.6082317.271.6097


Phone: Fax:

787.469.6209787.919.7323 787.919.7319



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 and some of the smallest

(virtual companies that outsource most functions). 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

ORAL SOLID DOSAGE

OVER THE COUNTER

VETERINARY MEDICINE GMP Compliance & Production Support

PHARMACEUTICAL

BIOTECHNOLOGY

MEDICAL DEVICE


OVER THE COUNTER

ORAL SOLID DOSAGE

FOOD MANUFACTURING

COSMETIC MANUFACTURING

Commissioning EDUCATIONAL FACILITIES

HEALTH CARE FACILITIES

PHARMACEUTICAL

BIOTECHNOLOGY


MEDICAL DEVICE

OVER THE COUNTER

ORAL SOLID DOSAGE

FOOD MANUFACTURING

COSMETIC MANUFACTURING

SEMICONDUCTOR FACILITIES

COMMERCIAL BUILDINGS / FACILITIES (FABRICATION / ASSEMBLY MFG. INDUSTRIES)

POWER GENERATION FACILITIES

PROCESS (CHEMICAL) MANUFACTURING INDUSTRIES


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Industry Leadership Commissioning Agents, Inc. is heavily involved in professional societies and other industry activities. We

believe this involvement can lead to opportunities for cost and time savings in many development and

manufacturing operations, including the project delivery process. We have as our corporate mission to

help the industry achieve these savings, become more competitive, reduce the cost of the products to

the customers, and improve availability of the products to the patients who need them.

Nearly 20% of our employees are active in one way or another in professional societies (primarily ISPE).

We serve on international committees, boards, guidance document‐writing task teams and local

chapters. Moreover, our staff speaks globally on subjects such as risk‐based approach to validation,

integrated commissioning and qualification, and related topics.

The organizations Commissioning Agents, Inc. and our staff are involved in include:

ISPE (COMPANY OF THE YEAR – 2002 & 2009)

PDA

ASQ

RAPS

ASTM E55 COMMITTEE

ASME

ASHRAE

BUILDING COMMISSIONING ASSOCIATION

ASSOCIATION OF ENERGY ENGINEERS

PROJECT MANAGEMENT INSTITUTE

AICHE

IEST

IEEE

SOCIETY FOR RELIABILITY AND MAINTENANCE PROFESSIONALS

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.


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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.

Differentiating Ourselves Our customers tell us we stand apart from other contractors for three reasons: We help fix issues and, more importantly, drive them to completion. We will attempt to foresee and minimize and/or avoid road‐blocks to get issues retested properly, with documentation, to meet clients’ expectations. We do what is in the customer’s best interest, even when it may not be in our best interest. We identify issues and propose workable solutions. Our internal quality system will ensure that our deliverables are professional and free from grammatical, spelling, and document formatting errors prior to submittal. This program works as a cooperative team with clients, engineers and contractors. Moreover, we consider schedule, client requirements and project costs while keeping an eye on the targeted results.


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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.


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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.”

“Commissioning Agents was key to improving our operations and compliance after we received an FDA

Warning Letter. They didn’t just tell us what was wrong; they helped us implement practical compliance

solutions. Upon re‐inspection, the warning letter was lifted and there were no 483 observations.”

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.


Phone: Fax:

317.271.6082317.271.6097


Phone: Fax:

787.469.6209787.919.7323 787.919.7319



Premier Provider Commissioning/Validation are 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.

Strong Performance = Solid Growth

PerformanceDriven Growth

With current annual sales of nearly $45 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.

cai company profile as 06-05-14

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