Ensuring sample safety and integrity is a priority in many cell and gene therapy applications, given the highly sensitive nature of these products. With even small changes in production and storage parameters putting product quality and Good Manufacturing Practice (GMP) compliance at risk, maintaining optimal conditions is of paramount importance.
Recent years have seen significant advances in remote monitoring systems for cell and gene therapy workflows. Capable of real-time, continuous supervision of laboratory equipment such as refrigerators, freezers and centrifuges, these systems offer proven benefits for enhanced sample protection, operational efficiency, cost optimization and regulatory compliance. However, when it comes to putting these solutions in place, understanding how these technologies create and transmit data is critical to support the U.S. Food and Drug Administration’s (FDA) latest 21 CFR Part 11 requirements.
Achieving 21 CFR Part 11 compliance in cell and gene therapy production
21 CFR Part 11 serves as a basis for the replacement of paper documents by electronic information, and requires cell and gene therapy manufacturers to adopt procedures and controls to ensure the authenticity, integrity and, where appropriate, confidentiality of electronic records. However, 21 CFR Part 11 requirements differ depending on whether electronic records are managed using a closed or open system.
- Closed systems are those under the control of individuals who are also responsible for the electronic records managed by the system, such as an intranet-based build and test system.
- Open systems are those where the electronic records and network infrastructure are managed by different teams, and include any systems that transmit data via the internet.
For closed systems, key 21 CFR Part 11 requirements include the need for robust validation, the ability to limit system access to authorized individuals, and well-maintained documentation on system access and maintenance, among other specifications.
In the case of open systems, the 21 CFR Part 11 requirements go further, and include additional conditions for document encryption and the use of digital signature standards to ensure the authenticity, integrity and confidentiality of records.
Advanced remote monitoring and connectivity solutions for 21 CFR Part 11 compliance
Smart laboratory equipment and control systems are playing an increasingly important role in cell and gene therapy workflows by providing real-time, continuous supervision of critical laboratory equipment parameters. These technologies can securely notify users about off-limit measurements, thereby boosting laboratory efficiency and productivity by reducing sample failures and the need to repeat experiments.
Thermo Fisher Scientific offers a broad range of remote monitoring systems to support cell and gene therapy manufacturers. Solutions such as the Thermo Scientific™ Smart-Vue™ Pro are designed to facilitate compliance with a wide range of regulatory standards, including 21 CFR Part 11. The Smart-Vue Pro system delivers fully traceable data logging and secure user-level access to system functionality at anytime from anywhere with internet access. The advanced modular, customizable architecture of the Smart-Vue Pro system means it can monitor many pieces of equipment or multiple parameters within one piece of equipment at the same time.
Some options, such as the award-winning Thermo Scientific™ InSight™ wireless cold storage monitoring system, feature advanced analytics and remote diagnostics to protect valuable samples and help avoid costly equipment failures by proactively identifying performance issues. By anticipating instrument failures and maintenance needs, the system can trigger suggested corrective actions, helping laboratories move from a ‘fail and fix’ mindset to a ‘predict and prevent’ approach. In this way, customers can gain better insight into the overall health of their equipment over time, instead of waiting for issues to arise.
These technologies are already helping cell and gene therapy manufacturers benefit from enhanced workflow efficiency, while assuring the highest levels of data integrity and 21 CFR Part 11 compliance.
Want to know more about 21 CFR Part 11 in the connected laboratory?
This product is intended for General Laboratory Use. It is the customer’s responsibility to ensure that the performance of the product is suitable for customer’s specific use or application.