Operational qualification protocol cum report shall consist of minimum contents but not limited to.
- Overview
- Purpose
- Background
- Responsibility
- Requalification
- System Description
HANDLING, MANAGEMENT, AND INVESTIGATION OF DEVIATION
Operational Qualification Procedure
- Training Date
- Calibration Review
- Key Functionality
- Safety Features
- SOP verification
- Preventive maintenance procedure verification
- Operational testing
- Deficiency (if any) and Corrective Action Report
- Acceptance criteria
- Summary
- Post Approval
- Appendix: Abbreviations & List of Documents
For operational Qualification Protocol cum report writing with respect to activity
Pre Approval: It is described above.
Overview: under this section purpose, background about the installation qualification responsibility, requalification, and system description is come.
Operational Qualification procedure: Under this section training, calibration review, Key functionality, challenge test, safety feature, SOP verification, and Operational testing.
Deficiency (if any) and corrective action report: Under this section the Deficiency if any shall be reported.
Acceptance criteria: under this section check the acceptance criteria for operational qualification.
Operating and cleaning procedure of the trolley
Summary: Under this section summarized all the operational qualification activities.
Conclusion: this section gives the result of all the qualification activity and data that should be mentioned that it undergoes for performance qualification activity.
Post approval signatures: after the operational qualification, all the data is reviewed by the head of the engineering, production, and quality head and take the certification of its approval.
Appendix: Under this section mention the abbreviation and list of the document
