Ingenix® Suite GxP Compliance Module
Top Features of GxP Compliance Module
- Supports Compliance with 21 CFR Part 11 and EU Annex 11
- electronic signatures and four-eyes principle
- Full Audit Trail of Devices and the System
- Exporting of Audit Trail
Popular Applications for GxP Compliance Module
- Audit Preparation
- Filtering audit records by user, balance name, serial number, timestamp, and more
- Reviewing, Removing, and Commenting of audit relevant events
- Quality Assurance in GxP Environments
- Item No.:
- DSX5PC01---GXP01
*Custom/bulk order quotes are provided within 24 hours of request.
Choose your Ingenix Suite - Lab Data and Fleet Management Software
The GxP Compliance Module from Ingenix® Suite is designed to ensure that laboratory operations meet the stringent requirements of Good Practice (GxP) regulations. This module provides tools to record and manage compliance-related activities and streamline workflows.
The module centralizes critical information through two robust audit systems: the Device Audit Trail and the System Audit Trail.
The Device Audit Trail maintains detailed audit records for each device, documenting actions such as reviewing and commenting on events with precise timestamps. Users can filter these audit records by timestamp, module, username, event, serial number, balance name, and device type, ensuring comprehensive and accessible data management.
The System Audit Trail captures all compliance-related activities within the Ingenix® Suite logging critical system events, user activities, and modifications to lab data. This system allows users to filter and view audit records by timestamp, module, username, and event, ensuring that all actions are meticulously tracked and can be reviewed to uphold high standards of data accuracy and reliability.
Additional features include the four-eye principle, reviewing lab data, and legally binding electronic signatures. The module supports comprehensive reporting capabilities, enabling the generation of detailed, customizable compliance reports for internal reviews or regulatory submissions. These reports provide valuable insights into compliance processes and ensure adherence to industry standards. Real-time monitoring and reporting allow for proactive management of compliance issues, ensuring that your laboratory operations always remain compliant.
Ingenix® is a powerful software suite designed to optimize and simplify data and device management. It offers tools for data analysis and reporting, ensuring high efficiency and accuracy in your lab operations. Ingenix® allows you to easily create and send diagnostic files directly to the Support Team for streamlined service processes. With advanced role management, you can customize user roles with specific access levels to match lab responsibilities. The suite supports both LDAP and local user management, fitting seamlessly into your IT infrastructure. Additionally, Ingenix® provides flexible license activation options, both online and offline, through MySartorius.com. Transform your lab with Ingenix®—where innovation meets precision.
Disclaimer: The Ingenix® Trademark is registered in the EU, CN, IL, JP, SG, CH, TR, and GB.
Applications
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ApplicationGxP compliant use of Ingenix Suite
Features
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Device/Instrument CompatibilityCubis® II MCA
Product Information
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License Period5 Years
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Qualification Documents5 Years
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