| Overview |
The Quality/CAPA Options page allows you to modify the following:
| • | Quality/CAPA Types |
| • | Quality/CAPA Priorities |
| • | Custom Fields |
You can change the data set by selecting an available option in the drop list.
|
 |
Quality/CAPA Types |
Top |
|
Quality/CAPA (Corrective/Preventive Actions) types can be assigned to CAPA forms for classification purposes.
For each Type you can define a different set of rules, which are applied when implementing a Quality/CAPA form.
Quality/CAPA types can be included as criteria for automatic signoff workflow assignment.
To modify Quality/CAPA types, select the Quality/CAPA Types option from the drop list.
Quality/CAPA Type options will be available when defining the Quality/CAPA form in Omnify Desktop (General tab).
To add a Quality/CAPA type, click the Add toolbar button.
This will present the New Type dialog box.
When defining a type, you can set the following fields/options:
| Name |
Quality/CAPA type label/identifier |
| Description |
Description of Quality/CAPA type |
| Number Prefix |
Prefix to be used for the Auto Number scheme |
| Autonumber Group |
Auto Number scheme to be used for the Quality/CAPA type |
Once all fields/options are set, click the Apply or Add button to create the Quality/CAPA type.
To modify a Quality/CAPA type, click the Edit hyperlink in the Actions column.
This will present the Edit Field dialog box.
Once the desired changes are made, click the Update button to save the changes.
To remove a Quality/CAPA Type, click the Remove hyperlink in the Actions column.
|
|
Quality/CAPA Priorities |
Top |
|
The Quality/CAPA Priorities option allows you to define a list of Priorities that are used to define and classify the importance of quality forms.
To modify Quality/CAPA Priorities, select the Quality/CAPA Priorities option from the drop list.
Priorities options will be available when defining the Quality/CAPA form in Omnify Desktop (General tab).
To add a change priority, click the Add toolbar button.
This will present the New Priority dialog box.
When defining a change priority, you can set the following fields/options:
| Name |
Priority label/identifier |
| Description |
Description of priority |
Once all fields/options are set, click the Apply or Add button to create the change priority.
To modify a change type, click the Edit hyperlink in the Actions column.
This will present the Edit Field dialog box.
Once the desired changes are made, click the Update button to save the changes.
To remove a Change Priority, click the Remove hyperlink in the Actions column.
|
|
Custom Quality/CAPA Fields |
Top |
|
Quality/CAPA forms allow users to define 3 different types of custom fields:
| General Page Custom Fields |
Fields which are visible and assigned on the General page of the Quality/CAPA form.
These represent data assigned to the entire form itself.
|
| Affected Item Custom Fields |
Fields which are visible and assigned to each affected item of the Quality/CAPA form (Affected Items page). |
| Disposition Fields |
Custom Material Disposition fields that are assigned to each affected item of the Quality/CAPA form (Affected Items page). |
To modify custom Quality/CAPA fields, select the Custom Fields option from the drop list.
Each Quality/CAPA type can contain a different set of custom fields.
To set custom fields, first select a CAPA type.
To enable a custom field, specify a field name in the Name column.
Then click the Enable checkbox.
When defining the field, you can define the field value type to be either User Edit or Pick List.
Once the fields are defined, click the Save Settings toolbar button.
For Pick List fields, you can define the field values by clicking the Set Values hyperlink.
This will launch the Field Values dialog box.
To add values, type the new value in the New Value field and then click the Add button.
Note: you can specify multiple values to be added at once using a semi-colon as a delimiter.
To remove values, select the entries in the Values list and click the Remove button.
You can change the order by selecting the entries and clicking the Move Up and Move Down buttons.
You can sort the list alphabetically by clicking the Sort button.
You can copy the field settings from one type to another using the Copy To function.
To copy the fields from one type to another, first select the source type from the Quality/CAPA Type drop list.
Then, click the Copy To button.
This will display the Copy To options.
Select the target Quality/CAPA type and then click the Copy Settings button.
General custom fields will appear on the General page of the Quality/CAPA form (when the specific type is selected).
Custom Affected Item and Disposition fields will appear on the Affected Items page.
|