Whitepaper: Data integrity and 21CFR.11 for 7000RMS implementation
Learn about 21CFR.11 and Annex 11 requirements and how you can implement a rapid bioburden analyser designed to meet compliant operation needs.
The 7000RMS microbial detection analyser is ready to use in 21CFR.11 and Annex 11-compliant operations. This whitepaper 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.
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Analytical techniques, Biologics, Biopharmaceuticals, Bioprocessing, Biosimilars, Data integrity, Environmental Monitoring, Good Manufacturing Practice (GMP), Manufacturing, Medical Devices, Microbiology, QA/QC, Regulation & Legislation, Research & Development (R&D)