Are open systems ever permitted for GXP cleanroom monitoring?

Исследователь смотрит на пробирку с жидкостью

Open systems are not specifically excluded in GxP cleanroom monitoring, but require additional security measures “to ensure the authenticity, integrity, and as appropriate, the confidentiality” throughout the record’s lifespan. While cleanrooms in GxP-compliant companies are typically controlled-access to minimize risks for system misuse, 21 CFR 11 requirements for audit trails require all data to be associated with a secure digital signature (for detailed auditing). Open systems require stricter controls than do closed systems, including “document encryption and use of appropriate digital signature standards to ensure, as necessary under the circumstances, record authenticity, integrity, and confidentiality.” For the above reasons, open systems are rarely employed for cleanroom environmental monitoring recordkeeping.