Software for the pharmaceutical and food sectors
Darca Secure is based on Darca Plus but contains enhanced security for the pharmaceutical industry following recommendations prescribed in FDA 21CFR Part 11. It is designed to communicate with the Eltek GenII telemetry receiver/logger type SC250 only (and cannot be used with standard 1000 series wired loggers).
- Tamper proof and secure data as prescribed in FDA 21 CFR Part 11
- Audit trails
- Administrator and user hierarchy
Darca Secure stores data in a file format which is encrypted using a key that is only known to Eltek. In addition to this, a key is placed in the audit trail at the point of download, and is updated on any changes that are made to the comments section of the file. The program does not modify the actual data and all stored data is completely tamper proof. Darca Secure also has audit trail and user management features that follow guidelines for electronic signatures set out in 21 CFR Part 11.