iQue® 21 CFR Part 11 Software Module from Sartorius Lab Instruments GmbH & Co.KG

Description

Building on the productivity of iQue®, the 21 CFR Part 11 Compliance-Enabling Module helps maintain electronic records with seamless, integrated global event tracking, electronic signatures, and more.

With the 21 CFR Part 11 Compliance Enablement Module, user roles can be secured to ensure everyone has the appropriate level of access. Only authorized individuals can control actions executed by the equipment through the software.

Control the level of electronic signature frequency. Create standardized log comments for organizational consistency. The username, date/time stamp, and action performed are all stored in data files. The database and global audit log files can be exported to a pdf report. Electronic signatures are locked with the recorded action. Forecyt® with the 21 CFR Part 11 Compliance Enablement Module utilizes Windows Authentication to provide and maintain secure control over user IDs and passwords.