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Using Chromeleon 7 Chromatography Data System to …
Using the thermo Scientific Dionex Chromeleon 7 Chromatography data System (CDS) to Comply with 21 CFR Part 11 Compliance Guide Using Chromeleon 7 Chromatography data System to Comply with 21 CFR Part 11 Page 2 of 43 Table of Contents Introduction .. 3 PART 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES .. 4 Subpart A General Provisions .. 4 4 IMPLEMENTATION .. 6 DEFINITIONS .. 8 Subpart B Electronic Records .. 11 CONTROLS FOR CLOSED SYSTEMS .. 11 CONTROLS FOR OPEN SYSTEMS .. 31 SIGNATURE MANIFESTATIONS .. 32 SIGNATURE/RECORD LINKING .. 37 Subpart C Electronic Signatures .. 39 GENERAL REQUIREMENTS .. 39 ELECTRONIC SIGNATURE COMPONENTS AND CONTROLS .. 41 CONTROLS FOR IDENTIFICATION CODES/PASSWORDS.
Using the Thermo Scienti c Dionex Chromeleon 7 Chromatography Data System (CDS) to Comply with ... Using Chromeleon 7 Chromatography Data System to Comply with 21 CFR Part 11 Page 5 of 43 ... so reports update instantly as new data are included or .
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