Operation Qualification Test Results
| Procedure | Expected Results | Results As Expected (Yes/No) |
|---|---|---|
| SOP List | The draft version of SOP for operation and maintenance was available. The SOP number, title, revision number, and date issued were documented in the protocol. | Yes |
| OBSERVA® Software Security Level Verification | All the predefined access levels and password expiration times were verified. Each access level was verified for password security. Only the authorized users were allowed to access the system based on their access level. | Yes |
| OBSERVA® Software Screen Navigation Verification | The navigation of the OBSERVA® software was verified. he software allows a user to move from one screen to another. | Yes |
| OBSERVA® Software Configuration | All the configuration including report template, shortcuts, data fields, screen views, date/time format, groups, and global report heading of the OBSERVA® software were verified. | Yes |
| OBSERVA® Software Access Level Verification | All the access levels defined in the protocol were verified. The system allows the user to access the privileges depending on the user's access level. | Yes |
| BacT/ALERT Workstation Security Verification | The BacT/ALERT workstation security setup functions were verified and found satisfactorily. Each user access level was verified for password security. Only the authorized users were allowed to access the system functions based on their access level. | Yes |
| Barcode Scanner Verification at BacT/ALERT Workstation | All the scanned information of the bottles matched with the actual information for unaltered bottle. The bottle ID was not able to be scanned for the altered bottle. | Yes |
| BacT/ALERT Instrument Security Verification | The password protection capabilities and access levels were verified. The system allowed only the authorized user to access the instrument based on the user's access level and only the administrator to add or delete the user. Only the administrator has access to configuration, adding, deleting, and editing functions. | Yes |
| BacT/ALERT Instrument Alarm Verification Test | The open door alarm, high temperature alarm, and low temperature alarm function accurately. | Yes |
| Power Loss/Equipment Failure Test | The incubator failure alarm, controller failure alarm, UPS failure, and communication failure between incubator and controller module alarm was verified and found satisfactorily. | Yes |
| BacT/ALERT Instrument Screen Navigation Verification | The navigation of the BacT/ALERT instrument was verified. The software allows moving from one screen to another. | Yes |
| Barcode Scanner Verification at BacT/ALERT Instrument | All the scanned information of the bottles matched with the actual information for unaltered bottle. The bottle ID was not able to be scanned for the altered bottle. | Yes |
| System Function Verification | The system function test was performed to verify the system functions and trigger the operator error and instrument error alarms. All the functions were successfully verified. | Yes |
| Report Logged Temperature Verification | The incubator chamber temperature was randomly read from the calibrated thermometer. All the data match with the report printed from the system. | Yes |
| Enable/Disable Cells, Racks, Drawers Verification | The enable/disable function for cells, racks, and drawers was verified. All the functions work satisfactorily. | Yes |
| Data Backup Verification | The manual backup and automatic backup were performed and verified with date and time on both instrument and computer system. The report generated was backed up to the network drive and retrieved from the network drive. | Yes |
| Temperature Calibration Verification | The system can accurately calibrate the temperature. | Yes |
| Cell Calibration Verification | The system can accurately calibrate the cells. | Yes |
| Audit Trail Verification | The audit trail report was printed from the instrument and computer system. The activities in the report accurately represent the activity performed. | Yes |
| Archived Report Verification | The archived report was accessible and cannot be edited. | Yes |
| Empty Chamber Temperature Distribution Study | Twenty-two (22) thermocouples were distributed geometrically inside the chamber. The temperature was monitored continuously every 5 min for 24 h. All the temperatures recorded by the thermocouples remained within the required temperature range of 30–35 °C. | Yes |
| Loaded Chamber Temperature Penetration Study | To simulate the load condition, all the slots were filled with bottles with pre-filled media (60 bottles in each drawer). All the temperatures recorded by the thermocouples remained within the required temperature range of 30–35 °C. | Yes |