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Ensuring Regulatory Compliance and Data Integrity with MassHunter Software Solutions

 

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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…
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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)…
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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…
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Data Integrity Options for GxP facilities For Agilent ICP-MS and ICP-QQQ spectrometers Agilent ICP-MS solutions to help meet regulatory requirements Agilent ICP-MS and ICP-QQQ instruments are used for pharmaceutical applications such as elemental impurities analysis and extractables and leachables risk…
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