Part 11 Compliance
CTL, as the leader in ELISPOT technology, has carefully elevated its products and solutions onto a platform that permits the entire ELISPOT process to take place within an environment ready to fulfill the requirements from 21 CFR Part 11. CTL has combined instrumentation and software with a powerful "Part 11 framework." Features include:
- Secure data storage
- Audit trails
- Record retention management
- Access control
- Data integrity
All statements used within Part 11 are related to computerized system which, as defined by the FDA, encompasses hardware, software, trained users and organizational procedures and policies.
Although compliance needs to be established by each institute for their particular business requirements and organizational structures and cannot be achieved by purchasing a certain device or software, CTL provides instrumentation and software solutions that enable their customers to comply with such regulations in their work.Questions about Part 11? Please contact us.