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2100 Expert Security Pack 

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21 CFR Part 11 Compliant 2100 Security Pack 
With increasing focus on biopharmaceutical drugs and diagnostics, there's a strong demand for standardized and reliable analysis methods that comply with GLP, GMP and 21 CFR Part 11 requirements. The Security Pack Software is an add-on component of the 2100 Expert Software for the Agilent 2100 Bioanalyzer that manages electronic data and addresses the aspects of data security, integrity, and traceability mandated by the US Food and Drug Administration's (FDA) 21 CFR Part 11. With pre-validated methods, the Agilent 2100 Bioanalyzer offers a time-and cost-effective way to comply with 21 CFR Part 11 regulations and to easily replace manual slab gels and capillary electrophoresis systems.
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Related Information

Features
  • Data integrity – Software files contain raw and meta data, as well as the complete data history. All files are protected from modifications and deletions other than by authorized individuals.
  • Access control – Only users with a valid user ID and password can log on to the application, and access and modify any data files generated by the 2100 Expert Software.
  • Audit trail – Time and date of user actions, details on user admin and security violations are automatically stored in an audit trail. Logbooks include method, assay and analysis parameters.
  • Workflow management – The executable methods must include a predefined workflow, which comprises users with pre-set permissions and peer review cycles with electronic signatures.

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