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The road from concept initiation to commercial release is long and arduous. Success depends upon not only understanding the new product development process. But also the standards submission process, and the complex interplay between the two.
Five-Phase Design and Development Process Based on Best Practices
Design Requirements & Planning. Critical components: project plan, design requirements and preliminary hazard analysis (PHA), and feasibility.
Design & Development. Critical components: design specifications, initial traceability matrix and concept prototype(s).
Design Verification. Critical components: Design verification (with reports), testing protocols, and piloting.
Design Transfer. Critical components: Design transfer specifications, process/equipment validations, and actual production units' checklist (batch records).
Design Validation. Critical components: Concurrent validation protocols and reports, completed traceability matrix, and event management.
The path from concept initiation to commercialization is long and arduous. Success depends not only on understanding the development process. But also on the standards submission process and the complex interplay between the two.
Five-phase design and development process based on best practices
Requirements and Planning. Critical components: project plan, design requirements, preliminary risk analysis (PHA) and feasibility.
Design & Development. Critical components: design specifications, initial traceability matrix and concept prototype(s).
Design verification. Critical components: design verification (with reports), test protocols and piloting.
Design Transfer. Critical components: Design transfer specifications, process/equipment validations, and actual production unit checklist (batch records).
Design Validation. Critical components: concurrent validation protocols and reports, complete traceability matrix and event management.
Phone:(514)-214-1002
E-mail:contact@iotec.ca