Ensuring Regulatory Compliance and Data Integrity with MassHunter Software Solutions
Technical notes | 2021 | Agilent TechnologiesInstrumentation
Software
IndustriesManufacturerAgilent Technologies
Key wordsaudit, trails, projects, management, project, user, roles, print, worklist, create, server, content, trail, panel, data, ecm, control, masshunter, workstation, records, integrity, traceability, review, export, networked, bioconfirm, activity, privileges, entries, edit, activities, versioning, regulatory, access, checktune, generate, tof, report, customized, all, being, permissions, openlab, save, method, viewer, logs, permission, electronic, view
Similar PDF
Meeting Regulatory Compliance Guidelines with Agilent ICP-MS MassHunter and OpenLab Server or ECM XT
2021|Agilent Technologies|Technical notes
White Paper Meeting Regulatory Compliance Guidelines with Agilent ICP-MS MassHunter and OpenLab Server or ECM XT Overview The United States Pharmacopoeia (USP) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) are responsible for…
Key words
yes, yesecm, ecmrecords, recordsserver, serverelectronic, electronicicp, icpopenlab, openlabmasshunter, masshunteraudit, audituser, usersignature, signatureolss, olsspassword, passwordtrail, traildata
Support for 21 CFR Part 11 and Annex 11 Compliance: SDA Module for Agilent ICP-MS MassHunter Software
2021|Agilent Technologies|Technical notes
White Paper Support for 21 CFR Part 11 and Annex 11 Compliance: SDA Module for Agilent ICP-MS MassHunter Software Overview Part 11 in Title 21 of the US Code of Federal Regulations (commonly referred to as 21 CFR Part 11)…
Key words
yes, yesrecords, recordselectronic, electronicsda, sdaicp, icpmasshunter, masshunteruser, usersignature, signaturepassword, passwordaudit, auditaccess, accesssignatures, signaturestrail, trailsoftware, softwarecomputer
Meeting Regulatory Compliance Guidelines with Agilent ICP-MS MassHunter and OpenLab Enterprise Content Manager (ECM)
2021|Agilent Technologies|Technical notes
White Paper Meeting Regulatory Compliance Guidelines with Agilent ICP-MS MassHunter and OpenLab Enterprise Content Manager (ECM) Overview The United States PharmacopeiaI Convention (USP) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) have developed…
Key words
records, recordsecm, ecmicp, icpyes, yesmasshunter, masshunteropenlab, openlabaudit, auditolss, olsstrail, trailuac, uacsystem, systemdata, dataserver, serveraccess, accesschecks
Support for Title 21 CFR Part 11 and Annex 11 Compliance: Agilent OpenLab Server and OpenLab ECM XT
2024|Agilent Technologies|Technical notes
White Paper Support for Title 21 CFR Part 11 and Annex 11 Compliance: Agilent OpenLab Server and OpenLab ECM XT Valid for OpenLab Server and OpenLab ECM XT version 2.8 Overview US FDA Part 11 in Title 21 of the…
Key words
yes, yesecm, ecmopenlab, openlabserver, serverresponsibility, responsibilityorganization, organizationelectronic, electronicuser, usersignature, signaturesatisfied, satisfiedsignatures, signaturesrecords, recordsothers, othersregulations, regulationscomments