|Successful product development requires the orchestration |
of multiple complex systems and processes, sometimes
requiring worldwide coordination.
- Phase 1: Design Requirements & Planning. Critical components: project plan, design requirements and preliminary hazard analysis (PHA) and feasibility.
- Phase 2: Design & Development. Critical components: design specifications, initial traceability matrix and concept prototype(s).
- Phase 3: Design Verification. Critical components: Design verification and testing protocols and piloting and design verification report.
- Phase 4: Design Transfer. Critical components: Design transfer specifications, process/equipment validations and actual production units’ checklist (batch records).
- Phase 5: Design Validation. Critical components: Concurrent validation protocols and reports, completed traceability matrix, and event management.
Lisa Weeks, a marketing communications specialist at MasterControl, writes extensively about technology, the life sciences industry, and other regulated environments. Her two decades of marketing and advertising experience include work with McNeil Pharmaceuticals, SAP AG, SCA Mölnlycke Health Care, Crozer-Keystone Health Systems, and NovaCare Rehabilitation/Select Med.