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  • 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     2010  sales:           $27.75  million       Full  time  employees:     181  (175  Technical  Professionals;  6  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.  
  • 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   power  plants  and  other  projects  requiring  assurance  that  construction   Commissioning  &  Start-­‐Up   and  performance  specifications  are  met.  Whether  a  project  involves   Project  Delivery  Management   getting  a  new  facility  in  operation,  adding  a  piece  of  equipment  or  retro-­‐ Instrumentation   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   HIGH  PERFORMANCE  TEAMS   and  communicated  effectively  with   It  is  critical  to  have  a  well-­‐oiled,  efficient  team  of  professionals  who  are   all  team  members  to  get  the  work   familiar  with  our  procedures,  each  other  and  the  work  requirements.  All   done.  Above  all,  they  are  great  to   of  our  employees  are  full-­‐time,  permanent  workers  –  not  contract   work  with  and  we  certainly  look   forward  to  working  with  CAI  again  in   employees  thrown  into  an  unfamiliar  situation.  As  a  result  we  provide   the  near  future.”   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.