How the OOS Wizard Works

Compliance · OOS Events Dashboard · Step by Step

An Out of Specification (OOS) event occurs when a test result falls outside predefined acceptance criteria for a product or process. These events initiate formal investigations to identify root causes and ensure product quality, patient safety, and regulatory compliance.

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Accessing the OOS Wizard

1. Click the FileMaker Pro icon to open FileMaker.
2. When FileMaker opens, locate the large menu bar on the left.
3. Click SiCompounding (near the top).
4. From the center icons, click Pharmacy to open the Dashboard.
5. From the blue sidebar menu, click Compliance.
6. Select Out of Specification Events.

The following widgets are displayed:

• OOS Dashboard
• OOS
• OOS Reports

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OOS Widget (Wizard Entry Point)

• Click the OOS widget.
• The OOS Events window opens, displaying all new OOS reports in List View.
• This list represents the starting point of the OOS Wizard, allowing users to review, investigate, and advance OOS records through their lifecycle.

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Searching & Filtering OOS Records

Within the OOS Events window:

• Click the Search tab at the top
  or
• Click the View All button

This opens the Search window, showing related OOS records in List View.

Progress Status Filter

Use the Progress Status dropdown to filter OOS records by:

• Canceled
• Closed
• Moved to CAPA
• New
• Pending Approval
• Under Investigation
• Under Review

This allows users to quickly locate OOS reports at specific stages of the investigation workflow.

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Reporting & Exporting from the OOS Wizard

To the right of the Progress Status filter, three Report / Print icons are available. Each action applies to the current found set of records.

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PDF Report Export

1. Click the PDF Report icon.
2. Confirm the dialog:

   Exporting data from the found set of ### records to a PDF file on your desktop?

3. Click OK.
4. The PDF is generated and saved to your desktop.

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CSV Report Export

1. Click the CSV Report icon.
2. Confirm the export.
3. The Select Columns window opens.

Column Selection Options

• Clear – Removes all selected columns
• Select All – Selects all available columns
• Set as Custom – Saves selected columns for future use
• Use Custom – Reloads previously saved column selections

Recommended workflow:

1. Click Clear
2. Select commonly used report columns
3. Click Set as Custom
4. Test by clicking Clear, then Use Custom

Export Options

At the bottom of the window:

• Stop and Close – Cancels export
• Export and No Wait – Runs export in the background
• Export and Wait – Waits for completion before continuing

Once selected:

• A dialog displays “Generating Report”
• When complete, “Your Report Is Ready!” appears
• Click the report name to download
• The Export Field to File dialog opens

From here you can:

• Change the file name
• Select a save location
• Automatically open the file
• Create an email with the file as an attachment

Click Save, then Close.

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Printed Report

1. Click the Printer icon.
2. Confirm export to printer.
3. The document preview opens.
4. The Print dialog allows selection of:
   • Printer
   • Presets
   • Copies
   • Page range
   • File format
5. Click Print to complete.

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Detailed View (Wizard Detail Step)

• Click the Detailed View button.
• Opens the selected OOS record in Detail View, where:
  • Investigation details can be reviewed
  • Progress status can be updated
  • The OOS can advance to review, approval, or CAPA

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Summary

The OOS Wizard provides a structured workflow to:

• View and manage all OOS events
• Filter records by investigation status
• Export findings in PDF or CSV format
• Print records for audits and reviews
• Access detailed OOS records for investigation and resolution

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This completes the step-by-step guide on How the OOS Wizard Works.