DatPass is Fourtec’s administration management software, integrating with the DataSuite applications to help achieve FDA 21 CFR Part 11 for a range of Fourtec data logging systems.
The DatPass database, installed on a local PC or network, maintains an audit trail that automatically records all user activity within DatPass and DataSuite software, including date and time stamp, login details, input alarms details, and so on. The DatPass administrator can view the audit trail on screen or print any part of it to keep hard copy records.
DatPass is also used to manage all user access to the supported systems, including user login parameters, group and user privileges for relevant software functionality, digital signatures the users are permitted to sign data within electronic records, and other key CFR requirements.
The DatPass software package is also supplied with the extensive operation and validation manuals to help users meet strict industry regulations.