Operational Qualification Report

TEM030 Issue date

Operational Qualification Report

(Ref.VAL005)

Project Name
Project Number
Equipment
Serial Number
Manufacturer
Model Number
Process Line/Location
Protocol number

Table of Content

PROCESS DESCRIPTION ...........................................................................................................2 OBJECTIVE.............................................................................................................................2 INSTRUMENTATION/CALIBRATION.............................................................................................2 TEST FUNCTIONS PERFORMED IN THE OPERATIONAL QUALIFICATION PHASE AND OVERALL RESULTS

OBTAINED: .............................................................................................................................2 ADDITIONAL VALIDATION REQUIREMENTS..................................................................................2 OVERALL CONCLUSION............................................................................................................3 PERFORMANCE QUALIFICATION PROGRAM ................................................................................3

Approval Of The Completed Operational Qualification Report
Department Name Signature Date
Project Coordinator


Validation Manager


Quality Assurance Manager


Operations Manager


Production Manager


Approval signifies provisional approval of the equipment / system for production use.

File Location: Date Printed: Page 1 of 3

TEM030 Issue date

Operational Qualification Report

(Ref.VAL005)

Training and Procedures All training requirements stated in the Validation Plan has been
Established fulfilled and approved by the Production Manager
Training conducted Yes / No – Sign & Date
All SOP’s established Yes / No – Sign & Date

Overall Conclusion

Acceptance criteria for the overall program shall be based on the following:

  1. Successful precalibration data for all critical test instrumentation
  2. Successful completion of all test functions listed in Part 4.
  3. Successful postcalibration of all critical test instrumentation.

Tabulate and review all data referenced above. Form a conclusion as to the acceptability of the overall program based on the acceptance criteria specified above.

Conclusion:

(Text)

Performance qualification program

The following tests are to be conducted as part of the Performance Qualification phase:


Test Functions Acceptance Criteria
1.

2.

3.

Completed Operational Qualification Report:


Position Signature Date
Documented by


Checked by


File Location: Date Printed: Page 3 of 3

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