6 communication, 7 compliance – Metrohm tiamo 1.3 Manual User Manual

Page 32

Advertising
background image

6

Introduction

1.6 Communication

Easy and inexpensive integration into existing laboratory information systems,

central databases and long-term archiving systems is crucial for the acceptance
of PC-controlled analytical systems.

tiamo is communicative. LIMS systems can easily import work lists into tiamo’s
own sample table and also control them remotely, without any additional modules.
Data generated in tiamo are now exported in XML format. This enables the simple

incorporation into all LIMS systems currently on the market. Export to long-term
archiving systems such as NuGenesis SDMS or Scientific Software CyberLABlab
is also supported.

With the new Report Designer the analysis reports can now be drawn up simply
and flexibly. The Report Designer allows report templates to be freely defined. In

this way reports of one or more determinations can be produced at any time with
a selectable layout in pdf format or as a paper printout.

A special feature of tiamo is that status messages, error messages or results can
be transmitted from the method sequence to the user by E-Mail.

Overview of functions

Import of sample data

Several data export formats,such as XML, CSV, SLK

Direct export to NuGenesis SDMS, Scientific Software CyberLAB, etc.

Report designer

E-mail function for status messages, error messages, or results

Import of external measured values





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.

Advertising