Data integrity and accuracy are key points for pharmaceutical industries. Company procedures should establish how sensitive data is collected and stored. In the case of dispensing processes, information such as sub-batches used in dispensing rooms, tare, and net weights of weighed material are among these sensitive data. To meet the regulatory needs on data, the Life Sciences Weighing and Dispensing module provides the capability to:
Create equipment interfaced with the system.
Manual entry of data signed by a second person coming from equipment not interfaced with the system.
Manage calibration tasks for connected equipment.
Manage instrument controls for not connected equipment.
Equipment
Equipment can be configured in the Life Sciences Weighing and Dispensing Master under Dispensing setup > Equipment.
Details of equipment are available in the Instrument/equipment form under Dispensing setup > Equipment > Instrument/equipment.
Users can verify the communication of instruments with the system in the Test tab. A command can be executed to verify whether the instrument is sending the expected response back to the system.
If the equipment is not connected to the Life Sciences Weighing and Dispensing components (for example, gauges for the airflow), it can be configured in the Instrument/equipment form, but communication settings are not required.
Furthermore, external reports and data sheets can be attached to the equipment to store information about the device. Attachments can be added in the Attachments tab.
Equipment control configuration
The Life Sciences Weighing and Dispensing module allows for the controls, such as calibration and verification, to verify the accuracy of instruments used for weighing the materials and prevent users from using instruments that are not compliant with the specifications. Controls can apply to equipment, whether connected or not, to the Life Sciences Weighing and Dispensing components. Instrument controls can be manually created when needed, or they can be automatically enforced by the system based on a configured frequency.
It is also possible to calibrate the zero point of the scale. This is the point at which you want zero to be displayed when there is nothing on the platform.
The list of configured controls is available in the Scheduled controls tab.
Details about the control configuration are available in the Scheduled activity for instrument form under Dispensing setup > Equipment > Instrument/equipment > Scheduled controls tab > Scheduled activity for the instrument.
The Life Sciences Weighing and Dispensing module allows for the management of different types of controls as per the Activity drop-down menu:
Note – The usability status of the equipment is preserved.
Problem – The usability status of the equipment can be preserved or changed to Not usable.
Calibration – The usability status of the equipment is set to Not usable.
Verification – The usability status of the equipment can be preserved or changed to Not usable.
Maintenance – The usability status of the equipment is set to Not usable.
Exit Repair – The usability status of the equipment is set to Under repair.
Use on Assay – The usability status of the equipment is preserved.
It is possible to the define a period in days in the Notice days field to notify the operator in advance when a scheduled control is due.
For tasks that need to be periodically performed, it is possible to define the following information:
Start date of the control.
Expiration date of the control is the period after which an open control (both calibration and verification) expires. If the control expires, the system closes it and creates a new one according to the configuration of the task.
Until a new control must be created, applicable only to recurring tasks, for example, if a control has the monthly frequency and the Until field is set to 1 year, the system creates a task each month for one year.
Frequency of the control, for example, 1 day, 1 month.
A control can be made of a set of tests to be executed. Therefore, the control can be closed only once all the tests are executed and the outcomes are compliant with the specifications (i.e., the measured value is within the allowed range).
The list of tests applicable to a control is available in the Calibration tests tab.
Details about each test are available in the Test for scheduled activity form under Dispensing setup > Equipment > Instrument/equipment > Scheduled controls tab > Scheduled activity for instrument > calibration test tab > Test for a scheduled activity.
For each test, the user can define instructions to be displayed on the Life Sciences Weighing and Dispensing screen while executing the test to guide the operator and ensure the test is performed according to the standard procedures.
Equipment control execution
The execution of a test is performed in the Life Sciences Weighing and Dispensing Client. If the scale is not interfaced with the Life Sciences Weighing and Dispensing components, it is possible to use a scale emulator to simulate its behavior for testing purposes.
The list of equipment that needs to be verified is displayed when accessing the Life Sciences Weighing and Dispensing Client.
An authorized operator selects the equipment and clicks the Next button to identify the list of planned tasks.
The user selects the task and clicks the Next button to identify the list of tests to perform. Based on the configuration of the control, the user is required to:
Close the task by entering the outcome Compliant or Not compliant without executing any test. This provides the capability to capture whether the instrument has been verified and can be used in any weighing operation.
Execute one or multiple tests to verify the compliance of the equipment with the specifications.
The operator selects the test to be performed and clicks the Next button. The proportional indicator is displayed. The target weight is put on the scales, and the weighted value is displayed.
The test passes only if the measured quantity is within the acceptable range. The task is automatically set to Compliant if all tests pass. If at least one test fails, the task is set to Not compliant, and the scale status is Unavailable, so the user will not be able to use it during weighing operations.
A test can be re-executed by selecting the test and clicking the Repeat test button before the task is closed. When clicking the Repeat test button, the failed test is set to Canceled, and a new test for the same target quantity is opened. This way, the failed test is not taken into consideration by the system when determining the outcome of the task.
Additionally, it is possible to re-open a task (for example, after failure, after moving the scale from one workstation to another) by clicking New instrument control and selecting the task from the list of active instrument controls. After confirming the selection, the user is required to execute all the tests defined for the task, if any.
For the operator to perform the zero-point calibration, he/she must ensure that the platform of the scale is empty and the scale is stable and then proceed to the zero-calibration step. This step is used to guarantee that environmental conditions, such as the airflow, do not affect the results of any weighing operation.
For controls of non-connected equipment (for example, gauges for airflow), an operator must manually enter the value read on the gauge to execute the tests.
The second person verification for manual entry of a test value for gauges may be required if configured for the gauge.
An electronic signature may be required upon all instrument controls closure if enabled in File > Entities > Instrument/equipment > Instrument logbook > Close instrument logbook by selecting the Sign checkbox. The user is required to enter a username and password to sign the record electronically.
The second person verification may also be requested if configured for the selected control.
Notes and comments can be added upon task closure, electronic signature, and second person verification to add details about the control executed on the instrument.
The instrument control logbook captures all the instrument controls executed against the instrument. It is available in both the Life Sciences Weighing and Dispensing Client for dispensing operators by clicking the All controls and in the Life Sciences Weighing and Dispensing Master for supervisors in Dispensing setup > Equipment > Double click on the scale > Logbook.