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21 CFR Part 11 - What is it?
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21 CFR Part 11 is a United States Government Food and Drug Administration (FDA)-mandated regulation that requires all electronic records and signatures, paperless records, and reporting procedures related to the manufacture of a product be captured and stored securely for businesses under its control, such as the Bio-Pharmaceutical and Food and Beverage industries. 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 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 many HMI/SCADA Software allows you to design an application that meets the 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.

Many companies offers 21 CFR Part 11 consulting services to assist you with your goal of achieving 21 CFR Part 11 compliance. Using these services, you can reduce the time, effort, and expense of developing, implementing, and maintaining a compliant solution to meet the regulation.

Typically these services include:

  • Training

  • Assessment

  • Detailed Detection

  • Maintenance




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