Metrohm ^® Tiamo™ Titration Software

The latest quality standards and validation procedures have been used during the development and programming of the software. Tiamo sets new standards for GMP, GLP, and FDA compliance. In fact, Tiamo has been designed to comply with the demands of FDA Regulation 21 CFR Part 11 and its customer-specific interpretations. The system administrator determines access rights to program functions, methods, and results. User profiles are freely definable and the number of users is unlimited. Access to the software is password-protected and either the Tiamo or Windows^® login can be selected.

Digital signatures to sign methods and results are implemented in Tiamo. Two signatures with different features are available. With the Level 1 Signature (Review) the user confirms that the method is programmed correctly or that the analysis has been performed correctly. The Level 2 Signature (Release) is used to release the method or the result and protect it against further changes. This means that company-specific workflows can be displayed in Tiamo.

Data is protected against unauthorized access, alteration, or deletion in the database. The database itself controls access to the data in network operation and offers archiving and recovery functions.

A central audit trail records all user actions as well as important system events.

Compliance features of Tiamo:

• Designed and validated for FDA 21 CFR Part 11
• Central user administration
• Detailed access management
• Tiamo or Windows password protection
• Digital signature with two levels for methods and results
• Method and results history
• Detailed audit trail