Select a Country or Area
|
Contact Us
Products & Services
Technical Support
Solutions
Buy
About Agilent
Go to Part Number Search
Home
>
Products & Services
>
Instruments & Systems
>
Lab-on-a-Chip
>
2100 Expert Security Pack
Register
|
Login
2100 Expert Security Pack
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.
Buy
Ordering Details
Request A Quote
Where To Buy
Store Home
Related Information
Literature Library
Applications
Data Sheet (330 KB)
more...
Technical Support
Frequently Asked Questions
Get 2100 Expert SW (demo)
Parts Information
more...
Education & Events
Customized On-Site Training
e-Seminars
more...
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.
Application Areas & Software
Compliance Solution
Services
Installation Qualification (IQ) Service
Operational Qualification (OQ) Service (link to 2100 compliance page
Additional Information
2100 Compliance
Announcements