SOP-DD-001 Design and Development Control Procedure

Purpose

Ensure design outputs meet user needs, regulatory requirements, and risk controls.

Required Design Records

• User needs and intended use
• Design inputs and design outputs
• Verification and validation reports
• Design review minutes
• Design transfer records

Phase Controls

1. Plan design and development activities.
2. Define and approve inputs.
3. Produce and review outputs.
4. Verify outputs against inputs.
5. Validate product against intended use.
6. Transfer to controlled release.

Traceability

Each requirement must be linked to design output, verification evidence, and released build.