Our Services

Consulting

Commissioning, Verification/Qualification, and Validation

Controls and Automation

Medical Device Design Control

Process and Cleaning Validation

Process Engineering

Installation & Start- Up Commissioning

Our team will work with your team to accomplish installation and start-up commissioning of manufacturing systems and equipment. Our installation and start-up commissioning services includes the generation and execution  of factory acceptance testing (FAT), site acceptance testing (SAT) and commissioning protocols/checklists. During our installation and start-up commissioning all activities are documented using good documentation practices and troubleshooting is completed with a "make-right" approach that ensures all open items are suitably resolved prior to verification of the systems' critical aspects. Our installation and start-up commissioning services include:
  • Design Reviews
  • Factory Acceptance Tests (FATs)
  • Receipt and Inspection
  • Site Acceptance Testing (SAT)
  • Commissioning Protocol/Checklists
  • Punchlist Management
  • Spare Parts Assessment
 

Verification/Qualification and Validation

Verification/Qualification and Validation Consulting services include:
 
  • User Requirement Specifications
  • Function Requirement Specifications
  • Detailed Design Specifications
  • Critical ASpect Risk Assessments
  • Facility Validation Master Plans
  • Process Validation Master Plans
  • Installation Verification/Qualification
  • Operational Verification/Qualification
  • Performance Verification/Qualification
  • Process Performance Qualification
  • Cleaning Validation
  • SOP Generation
  • Change Control Assessments
  • Deviation/Investigation Management

We have experience with generating and executing verification/validation documents on various facility and process equipment and systems. We have also completed qualification projects for biotechnology, pharmaceutical, and medical device clients in following service areas:
  • Facility Utilities and Equipment Commissioning and Verification/Qualification
  • Analytical Instrument Qualification
  • Cleaning Validation
  • Process Validation
Get In Touch

If you are interested in learning more about how our company can help your business, please write to us using this form and we will respond promptly to your inquiry.

 
 
 
 
   
 
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