qTOWER / qTOWER iris series FDA 21 CFR Part 11 Compliance for qPCRsoft

FDA 21 CFR Part 11 Compliance for qPCRsoft

The redesigned 21 CFR Part 11 module for qPCRsoft provides a complete compliance framework for qPCR workflows. Centralized data storage ensures integrity and accessibility across authorized locations. A detailed user rights system enables secure access control, while structured electronic signatures support review and release processes. The extended audit trail documents every change and supports full traceability for regulated workflows.

Central Data Storage and Data Integrity

• Store all your instruments’ data into one server-based database. Access your data from where you need it, the lab, the office, anywhere your company authorizes.
• Review all changes to an electronic record by reviewing old versions of the record. 

Comprehensive User Management

• Assign our predefined user roles to your users or create new ones to your liking, with our detailed user rights scheme.
• Set password rules and user expiry dates to your liking, or use Active Directory coupling

Meticulous Audit Trail

• Review every change in our meticulous audit trail, with a record of the old and new value.
• Quickly filter by different measures to find the result you want.

Electronic Signatures – easily sign off on Review and Release

• Release your electronic records in a structured way, ensuring the principle of dual control with our signatures.
• Restrict users to only work with released templates.

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