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.