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Scientist holding a tablet with the Soft Matter Analytics™ Compliance Add-On for FDA 21 CFR Part 11, ensuring regulatory adherence in laboratories.

21 CFR Part 11 Compliance Add-On for Soft Matter Analytics™

$5,800.00 - $5,800.00
$5,800.00
$5,800.00 - $5,800.00
$5,800.00

Elevate your laboratory's compliance standards with the Soft Matter Analytics™ Compliance Add-On, designed to ensure high adherence to the FDA's 21 CFR Part 11 requirements. This add-on integrates seamlessly with Rheolution’s Soft Matter Analytics™ software, ensuring data integrity, security, and traceability for all Rheolution’s instruments used in the life sciences and chemistry.


Key Features:

  1. Electronic Record Keeping:
    • Secure, tamper-proof storage of electronic records.
    • Automated, time-stamped audit trails for all data entries and modification.
  2. User Authentication and Access Control:
    • Role-based access control to ensure only authorized personnel can view or modify data.
    • Strong password policies and enforced password expiration to prevent unauthorized access.
  3. Electronic Signatures:
    • Compliance with electronic signature standards.
    • Detailed logging of electronic signature instances for full accountability.
  4. Audit Trail and Reporting:
    • Comprehensive audit trails that record all actions within the system.
    • Exportable reports to facilitate internal and external audits.
  5. Data Integrity and Validation:
    • Ensures data integrity throughout the data lifecycle.
    • Regular validation checks to maintain system performance and compliance.

Benefits:

  • Regulatory Compliance: Ensure your lab operations meet FDA regulatory requirements, reducing the risk of non-compliance penalties.
  • Enhanced Security: Protect sensitive data with robust security features.
  • Improved Efficiency: Streamline compliance processes and reduce manual documentation efforts.
  • Reliable Audit Trails: Maintain comprehensive records for all system activities, simplifying the audit process.

Availability:

The Soft Matter Analytics™ Compliance Add-On is now available for order on our e-store. Equip your lab with the tools needed to maintain the highest standards of regulatory compliance and data integrity.