Metrohm tiamo 1.1 Manual - Manual (Page 35)

Compliance 7
1.7 Compliance
tiamo also sets new standards with respect to compliance with GMP, GLP and
FDA requirements. The latest quality standards and validation procedures have
been used during the development and programming of the software. Right from
the very start tiamo has been designed to comply with the demands of FDA
Regulation 21 CFR Part 11 and its customer-specific interpretations. This is
confirmed by a compliance certificate. A central user administration determines
rights of access to program functions, methods and results. Any number of users
with freely definable user profiles are possible. The system administrator has com-
fortable access to the user administration from any tiamo client. Access to the
software is password-protected and either the tiamo or Windows login can be se-
lected.
The use of digital signatures allows to sign methods and results. Two signatures
with different features are available. With the Level 1 Signature (Review) the user
confirms the he has correctly programmed the method or correctly performed the
analysis, whatever the case. 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.
All data are managed by version control and 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.
The Audit Trail protocols all user actions as well as important system events.
Compliance features of tiamo
• Designed and validated for compliance
• Central user administration
• Detailed access rights management
• tiamo or Windows password protection
• Digital signature with two levels
• Different signatures for methods and results
• Method and results history
• Detailed Audit Trail guarantees traceability