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OQ 英文模板Template PROC.006F[3]

Equipment Name

Validation #

EQUIPMENT IDENTIFICATION:

Prepared by: Date:

Notes in italic red are guidelines. These must be deleted in actual body of protocol.

REMOVE ALL RED TEXT BEFORE SUBMITTING.

Tables 1.0 through 4.0 are to be filled out completely – These are part of the Protocol.

1.0PRODUCT(S) TO BE QUALIFIED IN THIS QUALIFICATION:

Rationale:

2.0PRODUCT(S) TO BE USED IN THIS QUALIFICATION:

Rationale:

3.0OPERATING AND TESTING:

Sample Size Rationale:

____________________________________________________________________________________ ____________________________________________________________________________________ ____________________________________________________________________________________

Rationale (include Risk Assessment):

4.0TRAINING AND PROCEDURES:

5.0CALIBRATION:

If the calibration section was performed during IQ, this section does not need to be filled out.

(Just state that it is performed in IQ).

The following are Checklists for OQ Requirements/Verification.

Columns 1 and 2 are to be completed before execution. These are part of the protocol.

Columns 3 through 5 are to be filled out by hand as part of the execution.

(Attach a copy of the Calibration certificate for each listed instrument or equipment.)

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