Working with 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.

On the Work Order Completion Detail form, you enter a quantity for scrap and select the Case Management option from the Form menu.

The system enables the Case Management option only when a value resides in the Qty Scrapped To Date field or the value in the Qty Scrapped field is greater than 0.

The system calls the version of the Case Entry program (P90CG504) in add mode based on the version specified in the Case Entry Add Mode (P90CG504) processing option on the Versions tab of the Work Order Completions program. The system populates the branch/plant, lot number, item number, and customer caller number on the Add Case form from the user ID.