P S ANALYTICAL
EQUIPMENT QUALIFICATION MANUAL
MILLENNIUM MERLIN SYSTEM
Issue No: 1.01
Issue Date: September 1 2000
MANUFACTURED BY:
PS Analytical Lid
Arthur House
Crayfields Industrial Estate
Main Road, Orpington
Kent BR5 3HP
England
Tel (Int): +44 (0) 1689 891211
Fax (Int): +44 (0) 1689 896009
E-mail: psa@psanalytical.com
Website: www.psanalytical.com
SUPPLIED BY:
Manual Part No. MO25M070
Equipment Qualification Manual Page 1 of 44 Issue No. 1.01
Millennium Merlin System Date: September 1 2000This page is left intentionally blank
Equipment Qualification Menual Page 2 of 44 Issue No. 1.01
Millennium Meriin System Date: September 1 2000CONTENTS
SECTION 1 FINAL QUALITY CONTROL PROCEDURE (QC).....
3 The Aim of the Final Quality Control Procedure...
introduction 5
Flow Chart for Final Quality Control Procedure.
Requirements for Final Quality Control Procedure
eo
Printer (Optional) (BEC & Noise Traces can be copied to disc and downloaded
printer in the main office)
Glassware
Standard:
Reagents.
Instrument Settings
Chemistries 7
Specifications...
Procedure 7
SECTION 2 INSTALLATION QUALIFICATION (IQ) ..
The Aim of Installation Qualification ...
introduction 14
Flow Chart for Installation Qualification.
Requirements for Installation
Customer Requirements for Installation
Reauirements for Installation
Unpacking the Products
Inspection of the Product
Checking all Components Present
onnection and Assembly of the Products
Checking the Function of the Products ..
Completion of Documents.
SECTION 3 OPERATIONAL QUALIFICATION (OQ) ....
SECTION 4 CUSTOMER FILE (EQUIPMENT QUALIFICATION - EQ)...
Health & Safety Statement - 5.12...
ervice Schedules for Each I f the System - 5.6/5.7/5.8
‘Spares Requirements for Each Item of System - 5.9/5.10/5.11
Letter 4 - Notification of Installation - 5.3. a: ss
Installatior k List 1 - Signed by Customer - 5.4.
Final ertificate - 5.1
Installation Check List 2 - In duplicat
returned to PSA - 5.5
48 QQ Certificate - Two blank copies - one copy to be left in file. one copy to be
returned to PS) 5.4 nme
49 Dividers 17
9
N 200005 000
aa
Equipment Qualification Manual Page 3 of 44 Issue No. 1.01
Millennium Mertin System Date: September 1 2000
lo