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IPS

Maximizing Value

Our technical consulting streamlined the engineering and validation process and implementation for our client. Our strategies were based upon the risk- and science-based approach applied to the F&E Lifecycle of Design, Specification, Construction and C&Q. 

CQV Life Cycle Expertise

With 25 years of hands-on experience, IPS offers a comprehensive approach to understanding the regulations and requirements of working within the CQV life cycle to ensure the consistency and quality of the manufactured product.

 Our team of experts offers practical understanding and scientifically-based methodologies for risk- and science-based investigations, audits, remediation and quality system development services to help achieve your project goals and business objectives.

 We focus on increasing the efficiencies and improving cost and schedule performance of asset delivery and life cycle operations, from both a consulting perspective and on the owner’s side. Our application of industry accepted project management approaches and lean concepts, along with our collective experience, allows for efficient projects as well as providing a baseline for better Cost of Goods Sold related to the Life Cycle areas impacted by CQV activities.

Experience Highlights

 Improving Operations and Minimizing Costs

Consulting/Project Management

  • cGMP Audits
  • Project Design Reviews (Design Qualification)
  • Early Stage Planning
  • Validation Master Planning
  • ASTM E2500 Implementation
  • Validation Program Development
  • Project Management/Planning
  • Quality System Implementation
  • Risk Assessments/Implementation (FMEA/HACCP/Other)
  • FDA 483/WL/Consent Decree Remediation
  • Validation & cGMP Training
  • Project Information Management

CQV Services

  • FAT/SAT Support
  • Facility, Equipment and System Qualification (IQ/OQ/PQ)
  • Process Validation
  • Cleaning  Validation
  • Automation and Computer Systems Validation
  • Lab Equipment and Analytical Methods Validation
  • Environmental Monitoring

Document Development/Field Execution

  • Specifications (URS/FRS/DDS)
  • Bid Packages/Bid Evaluations
  • Submittal Reviews
  • Commissioning Documents (Pre-Functional/Functional Checklists)
  • Risk/Impact Assessments
  • Validation Master Plans
  • Protocols/Test Plans/Test Scripts
  • Summary Reports
  • Turnover Packages
  • Standard Operating Procedures (SOPs)

 

Expert Isight