FactoryTalk Batch electronic signatures

FactoryTalk Batch

electronic signatures are electronically recorded representations of a signature and their associated data. Signature data includes time stamps, security permissions, meanings for signoffs, and comments. When a signature request is created, an entry is recorded in the Event Journal. If the signature request is user generated, a

Signature

dialog box is displayed. Additional journal entries are recorded when a signature request is completed, user canceled, system canceled, or when a signoff is successful or unsuccessful. These electronic signatures include all the components necessary for compliance with 21 CFR Part 11.

A

Signature

dialog box displays context information to the user based on the signature request type. For example, a

Command Signature

dialog box displays

Time Generated

,

Batch ID

,

Procedure ID

, and

Command

.

There are several steps involved in configuring and executing electronic signatures.

The requested user information in a

Signature

dialog box is defined by the signature template configured in the area model. Signature templates determine the number of signoffs required to complete a signature request. Each signoff has associated security permissions, meaning, and may require a comment. Signature templates are used with:

Signature templates are used to generate signature requests displayed in

FactoryTalk Batch View

,

FactoryTalk Batch View HMI Controls

, and

e

Procedure

.

Signature templates determine the credentials and number of signoffs required for steps defined as part of a Recipe Approval process.

See the

FactoryTalk Batch Equipment Editor User Manual

, publication

BATCH-UM004

for information on configuring signature templates.