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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 2000 This page is left intentionally blank Equipment Qualification Menual Page 2 of 44 Issue No. 1.01 Millennium Meriin System Date: September 1 2000 CONTENTS 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