 |
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.
