EUROTHERM has updated its 5000 series data acquisition recorders to meet FDA digital data storage and electronic signature requirements. When required, a functional specification is created along with a test specification for the installation qualification.
The recorder is supplied configured and tested to the standards required by the guidelines. As required by the FDA's CFR21 Part II, the new 5000 series has full security access, controlled by unique operator logins and before annotation, digital signatures with password checks are required.
A batch control option includes features such as clearing of data fields and electronic signatures. All information is time stamped and embedded alongside the process data, and archive files are binary encoded with checksums that prevent tampering.
Email 5000GAMP3@eurotherm.co.uk with return contact name and email address for sample validation documentation for the new instruments. Eurotherm Australia 02 9634 8444.