| Overview |
The General Page contains the following sections:
To modify any of the general fields, click the Edit Fields toolbar button.
This will place the fields in an edit mode and allow the user to set field values.
To cancel the editing mode, click the Cancel toolbar button.
To apply any field value changes, click the Save Settings toolbar button.
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Quality/CAPA Numbers |
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Quality/CAPA Numbers represent the key field by which all change information is tracked.
Each Quality/CAPA item will have a unique Change number.
Numbers can be manually assigned by typing directly into the Number field, or automatically generated by the system.
When using the automatic number generator, Desktop will read the Number from the existing Quality/CAPA items in the system (based on the selected Type).
To use the Automatic Number Generator, first select a Type.
To retrieve the next number you can click the Get Next Number icon.
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Quality/CAPA Types |
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Quality forms can be created and classified to represent any type of problem,
such as Corrective Actions (CAR), Preventive Actions (PAR), Supplier Corrective
Actions (SCAR), Non-Conforming Materials Report (NCMR), Customer Complaints, etc.
Quality form types can determine custom fields, required fields, Quality/CAPA Number
format, and workflows. Quality Types are defined in the Administrator.
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The Owner setting is a way that you can define who is responsible/overseeing the closure of the issue.
When editing the Owner field, you will be able to browse for an Omnify user.
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The Priority setting is a way that you can use to alert users to the importance of a specific Quality/CAPA issue.
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The Due Date field can be used to define the target closure date of the issue.
When editing the Due Date you will be able to browse for a date.
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Description |
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The Description field is an open text field.
You can type in any characters and use carriage returns in this field.
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The Reason field is an open text field.
You can type in any characters and use carriage returns in this field.
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Custom Fields |
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You can create Custom fields that will be displayed on the General page of the Quality/CAPA form.
Custom fields are defined in the Administrator and can be open text fields or pick list options.
Each Quality Type can have a different set of custom fields.
For example, Corrective Action forms can have different fields than Non-Conforming Material forms.
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Projects associations provide you with a way to link Quality/CAPA items and projects for searching, classification, signoff workflows, and/or permission purposes.
You can define multiple projects for any Quality/CAPA item, and multiple Quality/CAPA items can appear under the same project.
Projects are associated on the General page of the form.
To add a project, select the desired project from the All Projects list and then click the Add > button.
To remove a project, select the desired project from the Assigned to Item list and then click the < Remove button.
Clicking the project name hyperlink will open the project.
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Business Units |
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Business Unit associations provide you with a way to link Quality/CAPA items and business units for searching, classification, signoff workflows, and/or permission purposes.
You can define multiple business units for any Quality/CAPA item, and multiple Quality/CAPA items can appear under the same business unit.
Business Units are associated on the General page of the form.
To add a Business Unit, select the desired Business Unit from the All Business Unit list and then click the Add > button.
To remove a Business Unit, select the desired Business Unit from the Assigned to Item list and then click the < Remove button.
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Status Field |
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The Status field will indicate the internal status of the Quality/CAPA items (such as: Draft, Pending, Awaiting Release, Released, etc.).
While the Quality/CAPA item is still pending, you will be able to update the status and release the change by clicking the Change Status hyperlink.
This will display the Change Status dialog box.
The Update Status drop list will contain option depending on the current status.
Selecting an option will allow you to then update the status.
Refer to the Releasing Changes for more information on releasing Changes/ECOs.
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