Qualification Certificate

Equipment Information

Equipment Name: Device Inspection System (Vision/Microscopy)

Equipment ID: [Equipment ID]

Subcategory: NDDS – Drug-Eluting Stents / Coated Devices

Area: QC/R&D

Qualification Flags

• DQ: Yes
• IQ: Yes
• OQ: Yes
• PQ: Yes

Qualification Details

Protocol References: [Protocol Ref]

Execution Dates: [Execution Dates]

Calibration Status: [Calibration Status]

Deviations Summary: [Deviations Summary]

Overall Qualification Statement

The Device Inspection System has been successfully qualified in accordance with the specified protocols and meets all regulatory requirements.

Approvals

Approved By: [Approver Name]

Date of Approval: [Approval Date]

Next Due Date

Next Requalification Due Date: [Next Due Date] (12M)