Configuring electronic records and signatures for cGMP equipment

Create electronic records and/or require electronic signatures for work performed on cGMP equipment. Current Good Manufacturing Practices (cGMP) are a set of standards established by the United States Food and Drug Administration (FDA) to regulate the manufacturing processes of the food, pharmaceutical, and medical equipment industries.

Many companies have a combination of equipment regulated by cGMP standards as well as equipment not regulated by cGMP standards. Configure the system to take a snapshot of a record or require an electronic signature only when the work is performed on cGMP equipment.

Note: To indicate that a piece of equipment is subject to cGMP standards, select cGMP on the Record View page of the Assets, Positions, or Systems form.

To configure the system to create electronic records and/or require signatures for only cGMP equipment, set the CGMPONLY installation parameter to YES.

You must also define the electronic records/signatures for the EVNT entity on the eRecords Setup form.

See Defining Entities for Electronic Records and Signatures.

If CGMPONLY is set to YES and you have configured electronic records/signatures for the EVNT entity, the system creates an electronic record and/or requires a signature for work orders created/generated only for cGMP equipment.

Note: If you create a PM route that is associated with a work order containing cGMP equipment, the system creates an electronic record and/or requires a signature for the work order associated with the cGMP equipment in the PM route. The system does not create a separate electronic record or require a signature for each child work order on the PM route.

The electronic signatures for cGMP equipment configuration apply to work orders created/generated for cGMP equipment using the following forms:

Work Orders form
Work Orders Quick Close form
Service Requests form
Generate/Release Work Orders form