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Redesign of Quality System Needs a Subsystems Approach

January 19, 2009
Devicemakers should look to their subsystems to redefine and redesign their quality systems, Denise Dion, senior regulatory consultant for EduQuest and a former FDA employee, said. One way to approach quality system regulation is to define it from a subsystem level. By understanding the subsystems approach, devicemakers will waste less time focusing on each trivial regulation or standard, Dion said.
The GMP Letter