GE IS200DRLYH1AED Output Board Turbine Card

Description

GE General Electric Technical Specifications: IS200DRLYH1AED

This regulation requires the protection, accuracy, and quick retrieval of all records. Secured, computer

generated, time-stamped audit trails must be available to independently record the date and time of

operator actions that modify the manufacturing process.

Electronic records can be used to identify the ingredients and people involved in the production and

distribution of regulated substances, such as prescription IS200DRLYH1AED drugs. Additionally, electronic records ensure

accuracy, reliability, and security in data collection and record keeping.

Regulated industries that fail to meet 21 CFR Part 11 compliance risk the chance of Inspectional

Observations (483s), warning letters, or the authorized shut-down of one or more operations.

The electronic signature option included with Workflow allows you to design a workflow and associated

Form activities that assist you to meet the IS200DRLYH1AED demands of this regulation. The paperless environment

that results from using this feature benefits you with faster information exchange, improved ability to

integrate, trend and search data, a reduction in errors, and reduced data storage costs.

GE Intelligent Platforms offers 21 CFR Part 11 consulting services to assist you with your goal of

achieving 21 CFR Part 11 compliance. By using these services, you can IS200DRLYH1AED reduce the time, effort, and

expense of developing, implementing, and maintaining a compliant solution to meet the regulation.

These services include:

• Training
• Assessment
• Detailed Detection
• Maintenance

For more information, contact your GE representative.

Audit Trails

Workflow provides audit trail capability that allows you to keep a traceable record of actions that are

performed within your system. Actions that regulators are concerned with are typically those actions that

commonly occur in a production environment.

The audit trail is a key component in a 21 CFR Part 11 compliant system, but it can also be useful in many

different applications. The electronic signature audit trail contains a computer-generated, time-stamped

record of each electronic signature. Each record IS200DRLYH1AED clearly identifies all pertinent information about the

person who entered the signature, such as the person’s name, the time the signature was entered, and,

optionally, comments provided by the signer.

Enabling a workflow may require auditing because that is when the workflow changes are entering the live

process. Actions that are rarely performed can be tracked by using a manual paper system.

When an action that is configured to be audited takes place, an audit record is written to the SQL Server

database. The audit entry in the database includes the following information:

• A time stamp indicating when the record was created.
• An optional time stamp indicating when the action took place.
• The location where the action took place (that is, the assigned equipment resource).
• User context, which is any information related to the audit record and can include a bind to a

workflow variable and/or an expression.

• The associated topic.

Auditing can be enabled or disabled on a per topic basis; however, audit configuration changes and

electronic signatures are always audited, regardless of whether the global auditing is enabled or disabled.

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