Deviation Entries

Deviations are departures from the specified quality standards (defined in Quality Requirements and Specifications).

They can be intentional or unintentional, and they can be identified in the inbound or outbound processes. Deviations can have an impact or potential impact on product quality, GMP regulated systems, or regulatory filings.

To create a deviation entry, is necessary to fill in the document a value different from the expected to a certain field (the expected value is set on QRS).

Is possible to check deviations on Purchase and Sales Documents:

• Purchase/Sales Invoice;
• Purchase/Sales order;
• Inventory put-away/pick;
• Warehouse Receipt/Shipment;
• Posted Inventory put-away/Pick;
• Posted Warehouse Receipt/Shipment;
• Posted Purchase Receipt/Sales Shipment.

When choosing a Lot, on Sales Documents, is possible to ignore the Customer Requirements (to choose Lots that don’t respect the QRS defined):