Daco: GLP Requirements

The Daco software supports you in complying with GLP and 21 CFR Part 11 requirements. System operation and recorded data are protected from unauthorized interventions by efficient safety features.

Security management, audit trail, electronic signature and fraud-resistant data recording are essential attributes. If necessary, customer-specified requirements can be implemented on request.

Unauthorized access and operation of software functions, particularly of critical ones, is prevented by specific security routines.

The audit trail or parts of it can be displayed on the screen or printed by authorized personnel.

• Unique combination of User ID and password for secure and traceable access to the system control
• User manager to allocate user rights to different functions, particularly relating to critical operator actions
• Fraud-resistant audit trail with date, time and user stamp for chronological logging of access, events and actions, etc.
• Protection against subsequent manipulation of raw data and secure attribution of signatures to recorded data
• Saving of calibration data in a special file and additional storage together with the associated sensor raw data
• Exported data and documents are automatically provided with identifiers, e.g. file name, User ID