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

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Support for Title 21 CFR Part 11 andAnnex 11 Compliance:Agilent Cary WinUV PharmaWhite PaperOverviewUS 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...
Key words
yes, yeselectronic, electronicrecords, recordsresponsibility, responsibilityuser, userpassword, passwordorganization, organizationwinuv, winuvsignature, signatureaudit, auditrequirement, requirementothers, othersassociated, associatedregulations, regulationscary
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...
Key words
yes, yeselectronic, electronicuser, userrecords, recordspassword, passwordscm, scmresponsibility, responsibilitymicrolab, microlabsignatures, signaturesorganization, organizationaudit, auditrecommendation, recommendationsignature, signatureusers, usersothers
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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yes, yesecm, ecmrecords, recordsserver, servericp, icpelectronic, electronicopenlab, openlabmasshunter, masshunteraudit, audituser, usersignature, signatureolss, olsspassword, passwordtrail, traildata
 

Similar PDF

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Support for Title 21 CFR Part 11 andAnnex 11 Compliance:Agilent Cary WinUV PharmaWhite PaperOverviewUS 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...
Key words
yes, yeselectronic, electronicrecords, recordsresponsibility, responsibilityuser, userpassword, passwordorganization, organizationwinuv, winuvsignature, signatureaudit, auditrequirement, requirementothers, othersassociated, associatedregulations, regulationscary
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...
Key words
yes, yeselectronic, electronicuser, userrecords, recordspassword, passwordscm, scmresponsibility, responsibilitymicrolab, microlabsignatures, signaturesorganization, organizationaudit, auditrecommendation, recommendationsignature, signatureusers, usersothers
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...
Key words
yes, yesecm, ecmrecords, recordsserver, servericp, icpelectronic, electronicopenlab, openlabmasshunter, masshunteraudit, audituser, usersignature, signatureolss, olsspassword, passwordtrail, traildata
 

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