cGxP

Consulting

 

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Development
 

Product Development or Design controls are critical steps necessary to assure that a product will be safe and effective under the actual conditions of use.  cGxP has the expertise to address the broad scope issues of conceptual development and/or design and validation master planning, as well as the detail requirements of a design criteria.   Lack of these appropriate controls is the major source of regulatory actions Worldwide.

cGxP has a wide variety of experience and can assist you in focusing on any or all of the following elements in our Validation Services:

  • Validation Master plan

  • Site Plan & Facility Layout

  • Process & Facility Control Philosophy

  • Materials & Process Flow Analysis

  • Facility Design Criteria

  • Process & Utility Flow Diagrams

  • Process & Utility P& IDs

  • Floor Plans & Equipment Layouts

  • Design Specifications

  • Functional Descriptions

  • PLC Programming

  • Documentation Checking/Review

  • Design Reviews

  • Value Engineering

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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