Support for 21 CFR Part 11 and Annex 11 Compliance: SDA Module for Agilent ICP-MS MassHunter Software

Technical notes | 2021 | Agilent TechnologiesInstrumentation
Software, ICP/MS, ICP/MS/MS
Manufacturer
Agilent Technologies
Key words
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White PaperSupport for Title 21 CFR Part 11and Annex 11 Compliance:Agilent MicroLab PharmaOverviewUS FDA Part 11 in Title 21 of the Code of Federal Regulations (CFR), and its EUanalog, Eudralex Chapter 4, Annex 11, describe the requirements for electronicrecords and...
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White PaperMeeting Regulatory ComplianceGuidelines with Agilent ICP-MSMassHunter and OpenLab Server orECM XTOverviewThe United States Pharmacopoeia (USP) and the International Councilfor Harmonisation of Technical Requirements for Pharmaceuticalsfor Human Use (ICH) are responsible for developing new standards totest for inorganic (elemental) impurities...
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White PaperSupport for Title 21 CFR Part 11 andAnnex 11 Compliance: Agilent ICPExpert 21 CFR Part 11 softwareOverviewUS FDA Part 11 in Title 21 of the Code of Federal Regulations (CFR), and its EUanalog, Eudralex Chapter 4, Annex 11, describe...
Key words
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