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Design Controls...

Good Manufacturing Practices covered only manufacturing activities. When the FDA discovered, due to fatal failures, that the design process was not under control, the FDA defined Design Controls and expanded what was Goood Manufacturing Practice to cover development engineering and changed the name from GMP to Quality Systems.

Design Controls is the process of design and development engineering that is conducted and documented according to a plan. This plan changes (of course) but includes controls in the development of a medical device using design, documentation, test, procurement and communications.

When the FDA reviews your product, they do not look at the product - they look it the documentation. The design is NOT the product. The design is all the engineering and production documentation that defines and controls the creation/production of the product. The FDA verifies that using the same training, documents, materials and tools the same product is built. That is simple to understand. That is tough to do. It removes personal control!

As part of design controls and compliance to GMP, the proper engineering documentation must demonstrate repeatability such as:

specifications (requirements, design, functional, component, test, etc.),

mechanical drawings,

electronic & electrical drawings,

software code and controls,

failure analysis,

training,

test plan,

control of procurement sources,

certificate of compliance for materials,

process control, and

manufacturing data.

copyright by Compliance Consultants, Stamford, CT USA, September 2001