Soft Matter Analytics™ Compliance Add-On for FDA 21 CFR Part 11
Ensure your laboratory operations adhere to the highest regulatory standards with our Soft Matter Analytics™ Compliance Add-On, specifically designed to make our instruments compliant with the FDA’s 21 CFR Part 11 requirements. This add-on integrates seamlessly with all Rheolution instruments used in life sciences and chemistry.
Key Features
Electronic Record Keeping:
- Secure, tamper-proof storage of electronic records.
- Automated, time-stamped audit trails for all data entries and modifications.
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.
Electronic Signatures:
- Compliance with electronic signature standards.
- Detailed logging of electronic signature instances for full accountability.
Audit Trail and Reporting:
- Comprehensive audit trails that record all actions within the system.
- Exportable reports to facilitate internal and external audits.
Data Integrity and Validation:
- Ensures data integrity throughout the data lifecycle.
- Regular validation checks to maintain system performance and compliance.
Benefits
Regulatory Compliance:
- Effortlessly 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.
How to get the
Soft Matter Analytics™ Compliance Add-On ?
Should you have any questions or need further assistance, please do not hesitate to contact our support team. We are here to help you every step of the way.
Learn More
For detailed specifications and more information on how the Soft Matter Analytics™ Compliance Add-On can enhance your lab’s operations,
please download the detailed specifications: