Thermo Electron Announces Compliance Enabling Tools

Thermo Electron Corporation, a world leader in electrochemistry technology, today announced the availability of the Orion Star Navigator™ 21 CFR part 11 compliant data collection software and the Orion Star™ Series Meter Installation Qualification and Operational Qualification (IQOQ) documentation.

Designed to enable compliance with auditors and regulatory agencies, these tools set the bar for industry best-practices in the pharmaceutical, food and beverage and environmental industries.

On August 20, 1997, the Food and Drug Administration (FDA) ruling on 21 CFR Part 11: Electronic Records; Electronic signatures was put into effect. Aimed at modernizing the regulation of pharmaceutical manufacturing and product quality, this policy enables FDA auditors to facilitate timely reviews and audits. Part 11 guidance addresses systems validation, security and audit trails, system operation, system documentation control or archiving and record retention and recovery.

“The launch of these compliance tools shows that Thermo is dedicated to fostering industry best-practices that will help protect and promote the safety of our customers and public health,” noted Stuart Georgitis, director of instrumentation development and product management, Water Analysis Instruments at Thermo Electron. “The Orion Star™ Navigator 21 CFR part 11 and the IQOQ will ensure the highest level of quality is maintained, especially in the manufacturing of human drugs. As regulations evolve worldwide we will be at the forefront of innovation to ensure our customers remain compliant.”

Thermo Electron’s Orion Star Navigator 21 CFR part 11 compliant 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. The Orion Star Navigator 21 CFR part 11 compliant data collection software includes the following:

• User Management - User accounts are defined by a unique user name and password as provided by the Microsoft® Windows Operating System. Individual access privileges such as 21 CFR permission and Method Edit permission vary depending on each user’s profile.
• 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 that initialize after a set period of inactivity prevent unauthorized access as provided by the Microsoft® Windows Operating System.
• 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. The accounts may also include a password history and age limits that prevent old passwords from being reused and expire current passwords after a specified number of days in use as provided by the Microsoft® Windows Operating System.
• 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. The log file can be viewed, and exported. All data is stored in a secure database and cannot be changed or altered.
• Electronic Signatures - All changes are recorded with a digital signature and the users must provide reasons for changes. The user name and password are verified against the Microsoft® Windows Operating System user name and password.
• 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.

Designed to facilitate laboratory validations procedures, the Star Series IQOQ procedure provides the documentation that pharmaceutical companies need to comply with the requirements of their auditors and regulatory agencies. This documentation system includes easy-to-use forms that document the operation of a system and verify that the system operation conforms to design specifications.

Installation Qualification (IQ) demonstrates that the installation of the Orion Star™ Series Meter is verified by reviewing the instrument installed. The Operational Qualification (OQ) demonstrates that the Orion Star Series Meter operates appropriately throughout the normally intended operating ranges.

For more information about the Orion Star Navigator 21 CFR part 11 compliant data collection software, IQOQ documentation or any of Thermo’s water quality products, please visit the article website.