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21 CFR Part 11 Compliance with qPCRsoft
21 CFR Part 11 Compliance with qPCRsoft
The document outlines the compliance features of the 21 CFR Part 11 module for qPCRsoft, designed to ensure secure and traceable qPCR workflows. It is tailored for pharmaceutical and GxP environments, focusing on regulatory compliance, data integrity, and traceability.
Key Features
- Audit Trail & Version Control: Automatic logging of user activities with timestamps for transparency and traceability.
- Electronic Signatures: Secure documentation of data creation, review, and approval following dual control principles.
- User Management: Role-based access control for data and template editing.
- Centralized Data Handling: Secure management and storage of qPCR data in a centralized database accessible from multiple instruments.
- Qualification & Validation Services: IQ/OQ services for hardware and on-site software validation support.
Supported Standards
- FDA 21 CFR Part 11
- GMP/GxP Environments
Importance of Compliance
- Ensures data integrity and traceability.
- Meets regulatory requirements in development, quality control, and routine testing.
Order Information
- 21 CFR Part 11 Software Module: Item Number 844-00702-9, requires version 6 to operate, license bound to instrument serial numbers, compatible with qPCRsoft V6 on Windows 11.
- IQ/OQ Hardware Qualification: Item Number 846-500-900-2-N.
- Software Validation Support: Item Number 846-500-900-4-N.
Contact Information
Analytik Jena GmbH+Co. KG, Konrad-Zuse-Str. 1, 07745 Jena, Germany. Phone: +49 3641 77 70, Fax: +49 3641 77 9279, Email: [email protected], Website: www.analytik-jena.com
Catalog excerpts
21 CFR Part 11 Compliance with qPCRsoft For Secure and Traceable qPCR Workflows
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Key Features User Management: Assign user roles and access rights to control data and template editing according to your internal quality procedures. User management Audit Trail & Version Control: Benefit from automatic logging of all user activities with timestamps and details, ensuring full transparency and traceability of changes. Electronic Signatures: Securely document creation, review, and approval of data following the dual control principle. Audit trail Feel Free To Explore – With Compliance Built In Secure compliant qPCR workflows with the optional 21 CFR Part 11 module for qPCRsoft....
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* Requires version 6 to operate. ■ License bound to instrument serial number(s) ■ License can be installed on multiple PCs ■ Compatible with qPCRsoft V6 on Windows 11 B Learn more about our compliance module and schedule a demo. Analytik Jena GmbH+Co. KG Konrad-Zuse-Str. 1 07745 Jena • Germany Pictures: Analytik Jena GmbH+Co. KG Subjects to changes in design and scope of delivery as well as further technical development. Version 1.0 ■ en ■ 09/2025 888-042019-2-F © Analytik Jena GmbH+Co. KG analytikjena An Endress+Hauser Company
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