Understanding Electronic and Device Quality Records

Products such as pharmaceuticals, biotech, and medical devices require an audit trail for each batch, work order, or medical device manufactured.

An audit trail traces the manufacture of an item from design approval through manufacturing. The audit trail includes engineering changes introduced during the manufacture of the product. A quality assurance group must review the product prior to its release for sale or use.

You can review production records for a specific product and track defects. When you review records that are out of conformance, you can open a case for internal personnel to resolve the conformance issue.

You can use any value in the Enter Trace/Track processing option on the Display tab of the Track/Trace Inquiry program (P41203) as it is not significant if you trace or track an item when performing a product audit.

The system uses the document type entered in the Enter WO Document Type to Inquire processing option on the Defaults tab to determine whether to enable the As Built Comparison, Engineering History, and Production History buttons when you select a row on the Lot Management Workbench form. For example, the system enables all three buttons when the processing option is set to WO for work order.

When you access the Lot Management Workbench form for the first time, the system disables all buttons except the Signature and Audit button. On the Lot Management Workbench form, you enter an item number and lot/serial number to trace or track a specific item. You then select the parent line for the Lot B/P (lot branch/plant) and the system enables the Item Information and Quality Results buttons.

You next select the line that contains an inventory completion (IC). The system enables the As Built Comparison, Engineering History, and Production History buttons based on the document type setting in the Enter WO Document Type to Inquire processing option on the Defaults tab.