Software is designed to provide maximum security and data integrity for meeting regulatory compliance with the Food and Drug Administration's 21 CFR part 11 rule
Thermo launches its new Omnic DS software designed to provide maximum security and data integrity for meeting regulatory compliance with the Food and Drug Administration's 21 CFR Part 11 electronic records/electronic signatures rule.
The software is completely flexible and can be configured on a per user basis, on one system or across an entire network.
Designed as a versatile and intuitive program, Omnic DS logs all changes to files associated with the software, even when Omnic software is not running.
Record responsibility is established by using a specially configured Thermo Electron section of the Microsoft Windows event log to track all file modifications, assuring the highest level of data integrity.
Omnic DS software also creates complete, non-editable audit trails that are stored with the data to provide traceability for administrative reviews.
Original data is saved automatically, allowing results to be reproduced with ease.
Spectral histories are a record of all processing and signature events for the data and include the user name, data and time, along with the reason for the change.
At the heart of this software lies the Thermo Electron security administration server, which gives the system administrator control over software access, policies, and digital signature meanings in an easy-to-use interface.
It can be run stand-alone on a spectrometer workstation, or as a server application to administer Omnic spectroscopy software on one or all of the instruments in a facility.
This application allows the user to review and print a record of each user's security privileges.
Omnic DS works with the Windows 2000 or XP Professional security to re-authenticate the logged-on user's Windows account using Microsoft authentication.
This authentication occurs whenever the logged-on user launches Omnic DS software or applies a digital signature to a file.
This provides several advantages to the user and the system administrator.
There is no need to remember different passwords. Policy settings, such as password aging and the allowed number of log-on attempts, are those set for each user in their standard Windows account.
