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Data Integrity and 21CFR.11

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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.