Medical Refrigeration

FDA 21 CFR Part 11: FAQs

Explore & learn more

FDA 21 CFR Part 11: FAQs

FDA 21 CFR Part 11: FAQs

In March of 1997, FDA issued final part 11 regulations (21 CFR Part 11) that provide criteria for acceptance by FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper. These regulations, which apply to all FDA program areas, were intended to permit the widest possible use of electronic technology, compatible with FDA’s responsibility to protect the public health.

This paper answers some of the most commonly asked questions regarding °B Connected, a monitoring solution developed by B Medical Systems, that generates electronic records and 21 CFR Part 11.

FDA 21 CFR Part 11: FAQs

Download your free copy

    Leave a Reply

    Your email address will not be published. Required fields are marked *

    Close Popup

    We use cookies that are necessary to ensure the proper functioning and security of the website. Additional cookies are only used with your consent. Analytics cookies are used to monitor website traffic and optimize your user experience, evaluate which marketing channels are performing better and analyze aggregated data about usage of the website. Functional cookies make it possible to improve the functionality and personalization of our site. They may be activated by us or by third parties whose services are used on the pages of our website. Advertising cookies are placed by third-party companies processing your data to create audiences lists to deliver targeted ads on social media and the internet. Please see our cookie policy to learn more about how they are used on our website. Click on "Accept all", to accept the use of such cookies and go directly to the website or click on “Reject all", to reject the use of all the cookies. Please click on “More options” to change your cookie preferences. You can also change your settings at any time in our Privacy Center.

    Close Popup
    Privacy Settings saved!
    Privacy Settings

    These cookies are necessary to ensure the proper functioning of our website or for security reasons. These enable the main functions of the website to be used. The processing of the data collected through these cookies is based on our legitimate interest. You can always choose not to accept these cookies on your device and delete them using the configuration settings of your web browser. However, this risks your user experience being seriously degraded and some functions of the website may even no longer be accessible.

    Necessary cookies
    • test_cookie
    • wordpress_gdpr_cookies_declined
    • wordpress_gdpr_allowed_services
    • wordpress_gdpr_cookies_allowed
    • woocommerce_items_in_cart
    • woocommerce_cart_hash
    • wp_woocommerce_session_
    • NID
    • CONSENT
    • _GRECAPTCHA
    • __cf_bm
    • mtm_consent_removed

    Decline all
    Confirm your settings
    Accept all