Installation and Operation Qualification

LIMS Bridge - LIMS Communication Software

Software Version .............................................

Date of Installation .............................................
Installed by .............................................

Name (Customer) .............................................

Person in Charge .............................................
Address (Street) .............................................
(City) .............................................
(Country) .............................................

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Installation and Operation Qualification

1 Installation Qualification (IQ)

The IQ checks the system requirements and the correct installation of the software.

1.1 Supplied Documents

Reference Guide “LIMS Bridge” is available. OK NOK

1.2 System Requirements

The system requirements according to the Reference Guide “LIMS Bridge” OK NOK
are fulfilled.

The master instrument software has a suitable software version for LIMS OK NOK
Bridge (for LIMS Bridge 3.30 the master instrument needs software version
2.93 Build 547 or higher).

1.3 Installation of the Software

The installing file is successfully stored on the PC / server. OK NOK

The Installation Wizard can be started and finishes successfully. OK NOK

A LIMS Bridge desktop icon is created. OK NOK

2 Operation (OQ) & Performance Qualification (PQ)

The IQ has to be completed before starting the Operation Qualification. The OQ reviews, evaluates and tests the
software to verify that it is capable of operating satisfactorily within the defined functions.

2.1 Connection and Settings

The LIMS Bridge can be started by clicking the icon on the desktop. OK NOK
The LIMS Bridge Icon appears in the Windows Task bar.

The “Configurations” window can be opened OK NOK

A new connection to an Anton Paar instrument can be configured according OK NOK

to the LIMS Bridge Reference Guide.

Measurement settings can be defined. OK NOK

Audit trail settings can be defined. OK NOK Not relevant

Check data settings can be defined. OK NOK Not relevant

Adjustment data settings can be defined. OK NOK Not relevant

General Purpose Export settings can be defined. OK NOK Not relevant

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Installation and Operation Qualification

All settings are saved after confirming with <Save> OK NOK

2.2 Functional Tests

2.2.1 Instrument 1: ________________________________________________

The Lims Bridge and the instrument are connected: the instrument shows OK NOK
the Lims Bridge connection icon and the instrument is “connected” in the
Lims Bridges configuration window.

Measurement data are imported (command files) to the instrument OK NOK Not relevant
according to the set settings.

Measurement data are exported from the instrument according to the set OK NOK Not relevant
settings.

Audit Trail data are exported from the instrument according to the set OK NOK Not relevant
settings.

Check Trail data are exported from the instrument according to the set OK NOK Not relevant
settings.

Adjustment data are exported from the instrument according to the set OK NOK Not relevant
settings.

Data can be exported from the instrument to the selected General Purpose OK NOK Not relevant
Export storage location.

2.2.2 Instrument 2: ________________________________________________

The Lims Bridge and the instrument are connected: the instrument shows OK NOK
the Lims Bridge connection icon and the instrument is “connected” in the
Lims Bridges configuration window.

Measurement data are imported (command files) to the instrument OK NOK Not relevant
according to the set settings.

Measurement data are exported from the instrument according to the set OK NOK Not relevant
settings.

Audit Trail data are exported from the instrument according to the set OK NOK Not relevant
settings.

Check data are exported from the instrument according to the set settings. OK NOK Not relevant

Adjustment data are exported from the instrument according to the set OK NOK Not relevant
settings.

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Installation and Operation Qualification

Data can be exported from the instrument to the selected General Purpose OK NOK Not relevant
Export storage location.

2.2.3 Instrument 3: ________________________________________________

The Lims Bridge and the instrument are connected: the instrument shows OK NOK
the Lims Bridge connection icon and the instrument is “connected” in the
Lims Bridges configuration window.

Measurement data are imported (command files) to the instrument OK NOK Not relevant
according to the set settings.

Measurement data are exported from the instrument according to the set OK NOK Not relevant
settings.

Audit Trail data are exported from the instrument according to the set OK NOK Not relevant
settings.

Check Trail data are exported from the instrument according to the set OK NOK Not relevant
settings.

Adjustment data are exported from the instrument according to the set OK NOK Not relevant
settings.

Data can be exported from the instrument to the selected General Purpose OK NOK Not relevant
Export storage location.

2.3 Customer Training

Is the customer trained to use LIMS Bridge? YES NO

3 Signatures of Test Approval

At the time of the IQ/OQ record the software, its installation and its performance was found to be in
conformance with all manufacturer’s specifications.

Date: ...................

Signature of customer: Signature of Anton Paar GmbH authorized and trained

person:

..................................................... .....................................................

Attached Documents
others .....................................................

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