Metrohm tiamo 2.1 (ProcessLab) - Manual (Page 22)

1.7 Conformity ￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭
6 ￭￭￭￭￭￭￭￭ tiamo 2.1 (ProcessLab)
￭ Various export formats , e.g. XML, CSV, SLK (see Chapter 4.4.4.2.1, page
245).
￭ Automatic data export, e.g. to NuGenesis SDMS, Scientific Software
CyberLAB, etc. (see Chapter 5.6.8.5.1, page 1126).
￭ Report designer (see Chapter 4.4.1.4.1.1, page 202).
￭ E-mail functions for status messages, error messages or results (see
Chapter 2.6, page 81).
￭ Importing external measured values (see Chapter 5.6.3.10.2, page
859).
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 already being applied at the time of software development
and programming. tiamo has been deliberately oriented to the fulfillment of
FDA directive 21 CFR Part 11 and its customer-specific interpretations.
This is evidenced by a Certificate of Conformity. A centralized user admin-
istration defines the access rights for program functions, methods and
results, whereby any number 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 programmed the
method correctly or carried out the analysis correctly. With the second sig-
nature (Level 2, Release) the method or result is released and protected
against further alterations. It is thus possible to mirror customized workflows
in tiamo.
All data is organized according to the version and protected against unau-
thorized access, modification or deleting in the database. The database 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 1192).
￭ Detailed access rights (see Chapter 6.2.1.2.2, page 1194).
￭ Password protection under tiamo or Windows (see Chapter 6.2.2.2,
page 1202).