Sterilization System (EO/Gamma/E-beam) – Qualification Certificate Template

Qualification Certificate

Equipment: Sterilization System (EO/Gamma/E-beam)

Subcategory: NDDS – Drug-Eluting Stents / Coated Devices

Area: Production

Equipment Identifier [Equipment Identifier]
Protocol Reference [Protocol Reference]
Execution Date [Execution Date]
Calibration Status [Calibration Status]
Deviations Summary [Deviations Summary]
Overall Qualification Statement [Overall Qualification Statement]
Approvals [Approvals]
Next Due Date [Next Due Date]

DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes

Requalification Frequency: 12 Months

See also  Ophthalmic Sterile Filtration Skid (0.22 µm) – PQ Protocol