백서

Data Integrity and 21CFR.11

백서

In 7000RMS Implementation

Data Integrity and 7000RMS white paper
Data Integrity and 7000RMS white paper

The 7000RMS bioburden analyzer is ready to use in 21CFR.11 and Annex 11-compliant operations. 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.

A record-keeping system installed within GMP environments may be validated to meet the requirements of 21CFR.11 and Annex 11-compliant operations. The 7000RMS is designed to meet the needs of such validation.