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Commissioning

For more than 16 years, IPS has helped manufacturers of regulated products with their operations, commissioning, and validation projects. Our team of over 80 professionals is dedicated to providing high quality, pragmatic and value-added services. We provide services both integrated with the IPS’ full turn-key approach and as a stand-alone service. 

As part of our full turn-key services, our compliance team helps to ensure that IPS delivers capital projects that perform and conform. Our approach to managing Commissioning and Qualification (C&Q) activities comes from years of industry experience using widely accepted project management practices and tools. By fully integrating the commissioning, start-up, and qualification activities into the design and construction schedule, a true critical path is determined.

As stand-alone service providers, we have assisted clients by providing services that range from one-day consultations to multi-million dollar site projects. We typically deliver $15-20 Million in third party C&Q services per year.

By possessing the detailed knowledge and extensive experience in system qualifications, IPS can coordinate commissioning and start-up activities to minimize redundant qualification testing. Creating commissioning documents that capture critical system information in a GMP compliant format allows for commissioning data to be used in the execution of qualification studies. Concurrent execution of IQ activities during the commissioning and start-up assures that proper installation documentation and vendor certifications are in place prior to the formal qualification reviews and closeouts. On-site commissioning and start-up management by experienced C&Q personnel provides for early detection of problems that can delay qualifications and the overall project schedule.

IPS Compliance/Validation Services include:

  • Qualification and Validation 
  • Commissioning and Start-up 
  • Impact Assessments and Master Planning  
  • Construction & Design Interface/Review 
  • Equipment Selection 
  • Project Management 
  • Quality System Implementation 
  • Calibration System Consulting 
  • Audits 
    • Quality Systems
    • FDA-Style
    • cGMP
  • Remediation of FDA Form 483s/Warnings 
  • Validation and cGMP Training
  • Process and Cleaning Validation
  • Automation and Computer Systems Validation
  • Document Development/Management
    • Specification/SOP Preparation
    • Site/Project Document Control
    • Custom Protocols
    • Factory/Site Acceptance Tests
  • 21 CFR Parts 111 and 112, Dietary Supplement Final Rule

Click here for brochure on Affordable
Innovation for Commissioning.

Click here for brochure on Affordable
Innovation for Compliance Services.


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