Sponsored Content

Navigating Data Integrity and 21CFR.11

Navigating Data Integrity and 21CFR.11

As widely accepted, a complete record-keeping system installed within Good Manufacturing Practice (GMP) environments may be validated to meet the requirements of 21CFR.11 and Annex 11-compliant operations. The 7000RMS Microbial Detection Analyzer is designed to meet the needs of such validation of the entire system to help achieve overall compliance. This white paper considers the basics of 21CFR.11 and Annex 11 as they relate to 7000RMS implementation. It also details how the 7000RMS complies with ALCOA+ data integrity principles.

Download White Paper

To download this white paper, complete the form below. Once submitted, you will receive a link via the email you provided to download the white paper.

Company Type

By completing this form, you consent to have your information provided to the third-party sponsor of this content and may use your information to provide information about relevant products, services, and other opportunities which may be of interest to you . ISPE will store your information in a secure environment and may use your information to provide information about relevant products, services, and other opportunities which may be of interest to you. You may unsubscribe from these ISPE communications at any time. For more information or to unsubscribe, review our Privacy Policy or contact us at ask@ispe.org.