Security and Audit Control

Spectrum > Security and Audit Control

Spectrum contains a comprehensive security and audit solution, and follows the US National Institute of Standards and Technology (NIST) guidelines. Users can access only the options and data-sets for which they are authorized.

The following functionality is included:

Entry level unique User ID and Password
Option level security
Section level security
User Validity period
Password Validity period

Spectrum contains Electronic Signature functionality, whereby unique e-signatures are used in the system, which cannot be used by or reassigned to alternate users, and date and time stamps are applied automatically (not keyed in by the user).

System administrators can monitor and report on system security status, unauthorized access and transaction attempts, and view complete audit information on every transaction and system activity (including user name, date and time, and is a feature that cannot be disabled), and export the full data if required for further analysis.

The system has in-built controls to ensure entries are valid (e.g. field entries are valid, fields left blank that should contain data, values outside of limits, ASCII characters in numeric-only fields etc.), and that operations are performed in the correct sequence.

Spectrum can be managed using a secure HTTP environment if required.

Our Clients

Spectrum maintains control and quality limits to achieve TQM.

A unique solution with integrated Statistical Process Control.

Spectrum ensures that internal SOPs and performance parameters are deployed correctly.

Spectrum has the capability to acquire data directly from laboratory instruments.

Spectrum is a complete quality suite to manage end - to - end processes.

Spectrum is an FDA 21 CFR Part 11 compliant software solution.