What is 21 CFR part 11?
21 CFR part 11 is a regulation issued in 1997 by the American Food and Drug Administration (FDA) to define the requirements for submitting documentation in electronic form and the criteria for the use of legally binding electronic signatures.
Chapter 21 covers all regulations pertaining to GCP (Good Clinical Practice), GLP (Good Laboratory Practice) and GMP (Good Manufacturing Practice), collectively designated GxP, relating to the pharmaceutical and healthcare industries. CFR relates to the "Code of Federal Regulations". Part 11 covers all FDA regulated issues pertaining to electronic recordsand electronic signatures.
This regulation is of importance to all U.S. pharmaceutical and healthcare companies together with all international pharmaceutical or healthcare companies wishing to or currently exporting to the USA. In addition to the above, many countries or companies are using this regulation as a guideline for developing their own guidelines or regulations.
21 CFR part 11 is a regulation issued in 1997 by the American Food and Drug Administration (FDA) to define the requirements for submitting documentation in electronic form and the criteria for the use of legally binding electronic signatures.
Chapter 21 covers all regulations pertaining to GCP (Good Clinical Practice), GLP (Good Laboratory Practice) and GMP (Good Manufacturing Practice), collectively designated GxP, relating to the pharmaceutical and healthcare industries. CFR relates to the "Code of Federal Regulations". Part 11 covers all FDA regulated issues pertaining to electronic recordsand electronic signatures.
This regulation is of importance to all U.S. pharmaceutical and healthcare companies together with all international pharmaceutical or healthcare companies wishing to or currently exporting to the USA. In addition to the above, many countries or companies are using this regulation as a guideline for developing their own guidelines or regulations.
Main purpose of 21 CFR part 11
• To allow the use and submission of electronic records instead of having to store and submit a mass of paper documentation.
• To prevent, or at least reduce the risk of, records being deliberately manipulated to falsify results.
• To prevent unauthorized access to data.
• To ensure traceability of records to their originator or owner.
• To allow the use and submission of electronic records instead of having to store and submit a mass of paper documentation.
• To prevent, or at least reduce the risk of, records being deliberately manipulated to falsify results.
• To prevent unauthorized access to data.
• To ensure traceability of records to their originator or owner.
21CFR11 compliance cannot be provided by an instrument or analytical system alone. To fully comply with the rule, it is important for an organization that uses electronic records and electronic signatures to have Standard Operating Procedures (SOPs) that support and complement the functionality within the analytical system being used. In addition to the above, it is also the responsibility of the organization to ensure that all personnel involved have an adequate level of education, are aware of, and are trained on 21CFR11 related issues.
Companies that need to comply with this regulation must define their own realistic requirements. Compliance is not the responsibility of the equipment or system supplier. All the supplier can do is to provide systems that support compliance thus making it easier for the organization to become or remain compliant.
Companies that need to comply with this regulation must define their own realistic requirements. Compliance is not the responsibility of the equipment or system supplier. All the supplier can do is to provide systems that support compliance thus making it easier for the organization to become or remain compliant.
