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Directives for the manufacture of LDT’s is mandated by the FDA
The goal for development of a quality management system in the laboratory is to:
Laboratory Developed Tests are in-house laboratory tests approved by the FDA for manufacture across state lines.
Which QMS development phase listed below includes performance of a gap analysis of current laboratory processes?
Clauses describing Design Controls as listed in the CFR are included in CLIA regulations:
The Agile Stage Gate Hybrid technique is a product development methodology that divide activities into stages separated by decision points. This methodology was originally developed to ensure efficiency for the following:
The Stage Gate process is further managed through the assignment of a cross-functional teams to perform the following tasks:
Choose the correct definition Clinical Validity:
The function of the go/no go state gate is to verify the process is defect free. If a problem exist the gate is stopped.
The Validation Process includes (Performance Qualification (PQ(), (Operational Qualification (OQ) and (Performance Qualification(FQ) sections of the validation protocol: