User guide

Using the Guide
3
Compliance with FDA Title 21 CFR Part 11
To achieve compliance with FDA Title 21 CFR Part 11, use
fourtec’s software package: MicroLab together with DatPass.
The DatPass software is fourtec’s administration software.
Among other features, it defines the users that can log onto
the MicroLab software, their passwords and the digital
signatures the users are permitted to sign data within
electronic records (files). DatPass also maintains an audit
trail to keep track of all action performed within the system.
The system is secured with a serial port dongle, without
which the MicroLab and DatPass software packages will not
operate.