Module 14 2022

14/03/2022

Design Outputs

Design Output

• Individual Specifications • Test Data

• Components • Raw Materials

Functional Requirements Specification

• Drawings • Processes

Design & Process Development

Functional Req. 1.1.1 “The extended needle length shall be 20mm”

Review

Bill-of-Materials

• • •

Controlled CAD Files Technical Review Minutes Stage-Gate Review Minutes

Functional Req. 1.1.2 “No drug shall be delivered from the needle until the tip has reached a maximum depth of 15mm”

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Verification / Validation

21 CFR 820.30( f ) Verification: Confirm Outputs meet Inputs, Documented

21 CFR 820.30( g ) Validation: Conforms to User Needs/Intended Uses

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