TapeStation Software Security Module
Security module supporting FDA 21 CFR Part 11, EU Annex 11, and GxP compliance requirements.
- 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.
- 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
- 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.
Overview
Specifications
How it works
Built compliance into your TapeStation workflow
The TapeStation software security module makes regulatory compliance feel effortless. Here you can explore how it supports compliant workflows as part of everyday TapeStation use. Built directly on the familiar TapeStation software, it guides users through secure data acquisition, review, and approval with role-based access, audit trails, and electronic signatures.
News
Agilent TapeStation software customer survey
We are working to further develop the TapeStation software and would like to hear about your needs for regulatory compliance and future application needs.
14 Jun 2021
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