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 create a case for a failed test. On the Test Results Revisions form, select a row for a failed test and select the Case Management option from the Row menu.

The system enables the Case Management option only when a value of F (fail) resides in the Pass Fail field.

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 Enter Test Results program. The system populates the Customer Number and Caller Number fields on the Add Case form from the tester field. The system also populates the item number, branch/plant, and lot number from the Test Results Revisions form.