2100 Expert Security Pack
With increasing focus on biopharmaceutical drugs and diagnostics, there' 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 tracability mandated by the U.S. Food and Drug Admiinistration's FDA 21 CFR Part 11. With pre-validaed 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.
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 of 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 predefinded workflow, which comprises users with pre-set parameters and peer review cycles with electronic signitures.