Program: Configure Critical Traceability Element
This program lets you configure key data elements and critical traceability locations for critical traceability elements.
Exploring
This program lets you configure key data elements and critical traceability locations for critical traceability elements.
Things you can do in this program include:
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You will be able to enter or browse for a traceability element or key data element.
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You can validate the key data elements to highlight any potential errors in the data.
Starting
You can restrict access to the eSignature transactions within a program at operator, group, role or company level (configured using the Electronic Signature Configuration Setup program).
Electronic Signatures provide security access, transaction logging and event triggering that gives you greater control over your system changes.
Controls access to the maintenance of a critical traceability element in the Configure Critical Traceability Element program.
Solving
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Using
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In Setup Options define the following:
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Unified product traceability as FSMA or ED-DPP (Setup Options > Configuration > Manufacturing > Quality Management)
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Unified product traceability entries as the length of your retention period (Setup Options > History > Manufacturing > Quality Management)
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Enable the following fields within the Stock Code Maintenance program:
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UPT required checkbox.
Ensure the stock codes are traceable and/or serialized
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Use the following programs to define :and configure the required critical traceability elements and key data elements:
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Use the Key Data Element program to define your intended KDEs.
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Use the Critical Traceability Element program to add your required CTEs.
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Use the Critical Traceability Locations program to add your intended CTE locations of the defined CTEs and KDEs.
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Use the Configure Critical Traceability Element to configure your CTEs by linking them to the selected KDEs and critical traceability locations.
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1. Transaction processing:
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You can use the Unified Product Traceability Status program to review the status of the captured UPT data.
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Use the Unified Product Traceability Tracking program to select transactions for the relevant transaction types allowed for CTEs.
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The Unified Product Traceability Data Entry program can be accessed from both the Unified Product Traceability Status and Unified Product Traceability Tracking programs to capture KDEs and select and enter location details for CTEs.
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2. For UPT data that is no longer required, use the UPT Purge and Archive program to manage or remove data by archiving or purging it.
3. Use the report function to build and customize a report from the selected UPT data.
Referencing
Enter the traceability element code that you want to configure or use the browse function to search for an existing code using the Configure Critical Traceability Element program.
Use this option to validate the key data elements entered in the listview.
Use this option to filter the Critical Traceability Locations listview.
| Field | Description |
|---|---|
| Validation Status |
This indicates whether the key data element entered for the row has passed or failed validation. This is populated when using the Validate toolbar option. |
| Key Data Element |
Enter the key data element for the row, or use the browse function to search for an existing key data element. The key data element entered must exist on the Key Data Element table. |
| Error Description |
This displays a description of the error found for the row, if the key data element failed validation using the Validate toolbar option. |
The Critical Traceability Locations listview is populated with all the available locations that have been defined in the Critical Traceability Locations setup program. When maintaining an existing configuration, locations already included against the critical traceability element are indicated as such.
| Field | Description |
|---|---|
| Include |
Select this option to include the critical traceability location against the current version of the critical traceability element. This is the only editable field in this listview. |
| Location Description |
This displays the description of the critical traceability location, picked up from the Critical Traceability Location table. |
| Location Id |
This displays the location id of the critical traceability location, picked up from the Critical Traceability Location table. |
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