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.

On the Work Order Routing form, you select a routing operation and then select the Resource Competency option from the Row menu.

The system calls the version of the Resource Competency Information program (P05100) specified in the Resource Competency Information (P05100) processing option on the Versions tab of the Work Order Routing program.

The system populates the employee number in the Address Number field on the Work With Competencies form from the employee field on the Work Order Routing form. The value 01 in the Resource Type field is a fixed value and cannot be changed. You can review the competencies for the specified employee.

On the Routing Details form, you select the Equipment Search option on Form menu.

The system calls the version of the Work with Equipment Master program (P1701) specified in the Work With Equipment Master (P1701) processing option on the Versions tab of the Work Order Routing program.

The system displays the Work with Equipment Master form. The system populates the equipment number from the Routing Details form. You can also enter an equipment number to search for and review equipment related to a specific step in the manufacturing routing.