Metrohm tiamo 2.3 (process analysis) - Manual (Page 23)

￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭ 1 Introduction
tiamo 2.3 (for Process Analysis) ￭￭￭￭￭￭￭￭ 7
1.7 Conformity
Introduction
tiamo also sets new standards with respect to the fulfilling of GMP, GLP
and FDA requirements. The latest quality standards and validation pro-
cedures were implemented in developing and programming the software.
tiamo has been designed to fulfill the FDA directive 21 CFR Part 11
and the customer-specific interpretations. This is evidenced by a Certificate
of Conformity. A centralized user administration defines the access per-
missions for program functions, methods and results, whereby any num-
ber of users with freely definable access profiles are possible. The system
administrator can conveniently access the user administration from any
tiamo client. Access to the software is password-protected and there is a
choice of tiamo or Windows login.
The use of digital signatures makes it possible to sign methods and
results. There are two signatures available with differing properties. With
the first signature (Level 1, Review) the user confirms that he has program-
med the method correctly or carried out the analysis correctly. With the
second signature (Level 2, Release) the method or result is released and
protected against further modifications. It is thus possible to mirror cus-
tomized workflows in tiamo.
All data is organized according to the version and protected against
unauthorized access, modification or deletion in the database. The data-
base itself controls access to the data in network operation and provides
archiving and restore functions.
The "Audit Trail" protocols all actions by the user and all major system
processes.
Conformity relevant properties of tiamo
￭ Conformity is priority in development and validation.
￭ Centralized user administration (see Chapter 6.2.1.1, page 1318).
￭ Detailed access permissions (see Chapter 6.2.1.2.2, page 1321).
￭ Password protection under tiamo or Windows (see Chapter 6.2.2.2,
page 1328).
￭ Digital signature on two levels (see Chapter 2.3, page 23).
￭ One signature each for methods and results.
￭ Documentation of all method and result modifications (see Chapter
4.5.2.14, page 342).
￭ Traceability thanks to detailed Audit Trail (see Chapter 6.4.1.1, page
1366).