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Description
The TapeStation software security module provides the technical controls to securely acquire, analyze, and report data in laboratories that must follow the compliance guidelines of FDA 21 CFR Part 11, EU Annex 11, GxP, and similar national electronic record regulations. This security module supports customers for traceability with audit trails, data integrity, and access control.The TapeStation software security module consists of administration software, controller software, and data analysis software. The software is an independent software package and does not require a previous TapeStation software installation.
Features
- Account management: Administrators define users who are allowed to access the software. Only users that are added to the system can work with the electronic records.
- Access management: Customizable roles can be used to define the access level of a user, which can be grouped for permissions.
- Audit trails: Actions performed to a measurement are tracked in a file-specific audit trail. Changes done to the system are tracked in a system activity log.
- Data approval and approval workflows: eSignatures can be used to approve data. Custom workflows may be created to enforce an order of signatures and meanings.
- Unified reporting using templates: A predefined report layout is enforced by choosing a report template to standardize report generation.
- Simple and intuitive data acquisition, analysis, and reporting: The security module is based on the TapeStation software; both software focus on ease of use to boost your workflow.
- Ease of use for regulated processes: Easily manage users, permissions, approval workflows, acquisition, and data.
- IQ/OQ services: IQ/OQ services are available for the TapeStation software security module to ensure proper installation and operation of the system.
| Item | TapeStation Software Security Module |
| Company | Agilent Technologies |
| Price | Get PricingGet Quote for this Product |
| Catalog Number | TapeStation Software Security Module |
| Capacity | 80 GB (Hard drive) |
| Resolution | 1024 x 768 pixels |
| Memory | 8 GB |
| Optical System | Microsoft Windows 10 (64 bit) ; English (US) regional settings |
| Ports | 2 USB ports, USB-2 or higher |
