Thermo Scientific’s Orion Star Navigator 21TM , 21 CFR part 11 data collection software allows users not only to uphold FDA guidelines and to effectively operate to varying specification requirements world-wide, but also allows for significant savings in time and productivity associated with data management.
Product Detail
Specific features of Orion Star Navigator 21 CFR part 11 compliant data collection software are:
System Access (Login/Logoff) - Login is strictly regulated by entering a valid username and password. Security measures include account lockout after a predetermined number of unsuccessful login attempts and automatic password protected screensavers.
Password Rules and Management - Complex password capabilities (i.e., a combination of uppercase and lowercase characters, digits, and/or non-alphanumeric characters) may be enforced as a means of extended security.
Audit Trail – Records important events and includes in the audit trail function which lists user, date, time, severity of event, application, description of event, and details of the event.
Electronic Signatures - All changes are recorded with a digital signature and the users must provide reasons for changes.
Data Security - All data is stored in a database and it is impossible to remove or alter data in an uncontrolled manner. The database can only be accessed with the proper tools and user rights. Data integrity is verified each time data is accessed.
Companies using Orion Star Navigator 21 software can adopt paperless record systems and submit regulatory documents in the form of electronic records. These companies benefit from a more cost effective, time efficient system driving shorter approval processes.
Thermo Scientific has packaged this software as a stand alone product (Orion #1010007) or it is included in Specific Star Application Kits.