Varian, Inc. Analytical Instrument Qu Development of Varian, Inc. Instruments 23 3.2 Development of the Varian, Inc. Software 25. Varian, Inc. Analytical Instrument Qualification Overview

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  • Varian, Inc. Analytical Instrument Qualification

    Overview

    8510228900 Issue 3 February 2008

  • Varian, Inc. Analytical Instrument Qualification Overview

    Page 2 of 36 Publication no. 8510228900, Issue 3, February 2008

    Varian, Inc. Serving Industries Worldwide

    Biosciences

    Pharmaceuticals

    Clinical Research and Forensics

    Food and Agriculture

    Chemical Analysis

    Environmental

    Fuels and Energy

    Material Sciences

    Sales and Service Contact Details

    North America: 800.926.3000, 925.939.2400

    Europe, The Netherlands: 31.118.67.1000

    Asia Pacific, Australia: 613.9560.7133

    Latin America, Brazil: 55.11.3238.0400

    Varian, Inc. Web Site

    www.varianinc.com

    Varian, Inc. is the owner of copyright on this document and any associated software. Under law, the written permission of Varian Inc must be obtained before either the documentation or the software is copied, reproduced, translated or converted to electronic or other machine-readable form, in whole, or in part.

    First published December 2005. Updated in February 2008.

    Factor Four, Inspiring Excellence, Varian and the Varian logo are trademarks or registered trademarks of Varian, Inc. in the US and other countries.

    2005-2008 Varian, Inc.

  • Varian, Inc. Analytical Instrument Qualification Overview

    Publication no. 8510228900, Issue 3, February 2008 Page 3 of 36

    Contents

    Varian, Inc. Industry Awards........................................................ 5

    Preface - Varian, Inc. ..................................................................... 7

    Introduction to Varian, Inc. 7

    History of Varian, Inc. 8

    Real World Applications 9

    Financial Status 10

    Document Overview ................................................................... 11

    1. Quality Systems at Varian, Inc. ......................................... 13

    1.1 Quality Management System 13

    1.2 Auditing Procedures 14

    1.3 Employee Qualifications and Training 14

    2. Regulatory Compliance and Analytical Instrument Qualification ................................................................................ 15

    2.1 Good Laboratory Practice 15

    2.2 Current Good Manufacturing Practice 16

    2.3 Analytical Instrument Qualification 16

    2.4 When is AIQ Required? 17

    2.5 FDA 21 CFR Part 11 Electronic Signatures and Records 18

    2.6 Design Qualification 19

    2.7 Installation Qualification 20

    2.8 Operational Qualification 21

    2.9 Performance Qualification 21

    2.10 Preventative Maintenance and Re-qualification 22

    3. Analytical Instrument Qualification at Varian, Inc............ 23

    3.1 Development of Varian, Inc. Instruments 23

    3.2 Development of the Varian, Inc. Software 25

  • Varian, Inc. Analytical Instrument Qualification Overview

    Page 4 of 36 Publication no. 8510228900, Issue 3, February 2008

    3.3 Pre-installation 27

    3.4 IQ Documentation Provided by Varian, Inc. 27

    3.5 OQ Documentation Provided by Varian, Inc. 28

    3.6 Re-qualification 29

    3.7 AIQ Package Provided by Varian, Inc. 30

    3.8 Summary of Purchase and Qualification Procedures with Varian, Inc. 31

    3.9 Regulatory Compliance 32

    4. Customer Support ............................................................... 33

    4.1 Global Sales and Support 33

    4.2 Varian Customer Training Courses 34

    4.3 Support Agreements 34

    4.4 Consumables and Spare Parts 35

    4.5 Instrument Installation Procedure 35

  • Varian, Inc. Analytical Instrument Qualification Overview

    Publication no. 8510228900, Issue 3, February 2008 Page 5 of 36

    Varian, Inc. Industry Awards

    Varian, Inc. Awards:

    2004 Varian, Inc. is named Analytical Instrumentation Company of the Year by Frost and Sullivan Excellence in Industrial Technology Awards

    2002 Business Week rank Varian, Inc. among the Nations top growth companies

    2002 Scientific Computing and Instrumentation Magazine voted Varian UV spectrophotometers the best in quality, reliability and value

    2001 AusIndustry Certificate of Achievement ICP Project (Development of next generation ICP spectrometers)

    1999-2000 Applied Biosystems recognizes Varian Vacuum Technologies with the Outstanding Supplier Award

    1999 Australian Institute of Engineers - Engineering Excellence Award for Vista ICP Instrument

    19981999 Vankel Technology Group Recognition Award Partnerships Cooperation and support in the advancement of Dissolution Automation Total Solution

    1998 Industrial Research 100 Award Cary 50 UV-Vis Spectrophotometer

    1998 Silver Award Strategic Industrial Research International (Instrument Business Outlook) Excellence in Industrial Design Cary 50 Spectrophotometer

    1997 Industrial Research 100 Award - SuperProton Probe

    1997 Australian Institute of Engineers - Engineering Excellence Award for the Cary 50 and SpectrAA 220FS

    1997 Vacuum Products Massachusetts Quality Award

    1997 Industry Week Magazine names the Lexington MA site as one of Americas best plants

    1994 Industry Week magazine names NMR among the Top 10 List in its Americas Best Plants competition

  • Varian, Inc. Analytical Instrument Qualification Overview

    Page 6 of 36 Publication no. 8510228900, Issue 3, February 2008

    1994 Australian Institute of Engineers Highly Commended - Engineering Excellence Award for UltraMass ICP Mass Spectrometer

    1991 Stockholm, Sweden Richard Ernst Awarded the Nobel Prize in Chemistry (Varian, Inc. employee from 19631968) He and Wes Anderson developed Fourier Transform NMR the Discovery that made Magnetic Resonance Imaging practical

    1987 Industrial Research 100 Award - VXR wide line solids accessory

    1986 Varian Australia wins Australian Export Award

    1984 Industrial Research 100 Award - NMR spectrometer XL series data system

    1983 Australian Institute of Engineers (Victorian Branch) - Engineering Excellence Award for the GTA-95

    1978 Varian Australia wins Australian Export Award

    1977 Industrial Research 100 Award for SuperScan 3 UV-Vis Spectrophotometer

    1975 Industrial Research 100 Award - Model EM-390 NMR spectrometer

    1973 Industrial Research -100 Award for the PortaTestTM Leak Detector

    1972 Varian Australia wins Australian Export Award

    1971 Industrial Research 100 Award - Model EM-300 NMR spectrometer

    1971 Industrial Research 100 Award for Model 61 Carbon Rod Atomizer

    1970 Industrial Research 100 Award - XL-100 NMR spectrometer

    1967 Industrial Research 100 Award for AR-200 Atomic Absorption Spectrophotometer

    1966 Industrial Research 100 Award for AA-4 Atomic Absorption Spectrophotometer

    1964 Industrial Research 100 Award - NMR system model HRSC-1

    1963 Industrial Research 100 Award - Industrial Research superconducting Magnet to achieve 65,000 Gauss

  • Varian, Inc. Analytical Instrument Qualification Overview

    Publication no. 8510228900, Issue 3, February 2008 Page 7 of 36

    Preface - Varian, Inc.

    Introduction to Varian, Inc.

    Inspiring Excellence is at the Heart of Our Business.

    Varian, Inc. is a diversified, global technology leader helping customers innovate with confidence, enhance their competitiveness, and boost their efficiency.

    The headquarters of Varian, Inc. are in Palo Alto, California. Varian, Inc. manufactures in twelve locations throughout North America, Europe and the Pacific Rim and has sales and service offices worldwide. It is a major supplier of analytical instrument solutions, NMR systems, vacuum products, and associated services.

    Our businesses Scientific Instruments and Vacuum Technologies bring together high quality, innovative and user-friendly products with industry-leading service and support to create genuinely inspired solutions. Each person at Varian, Inc. is dedicated to our credo Inspiring Excellence. This calls on us to always act with integrity and with absolute commitment to our customers needs and dreams. At Varian, Inc. we are inspired by our customers and strive to inspire others in all we do.

    Our people, products and solutions enable customers to meet increasingly complex challenges in life sciences and industry.

    Varian, Inc. provides leading edge tools and solutions for diverse, high growth applications in life science and industry.

  • Varian, Inc. Analytical Instrument Qualification Overview

    Page 8 of 36 Publication no. 8510228900, Issue 3, February 2008

    History of Varian, Inc. The roots of Varian date back to 1948 when two brothers, Russell and Sigurd Varian, put their heads together to start their own company. Russ was a Stanford University graduate and inventor, and Sig was a Pan American Airlines pilot. Their innovation and enterprise built one of the primary companies in Silicon Valley, Varian Associates. Russ invention, the klystron tube, which helped make airborne radar possible before World War II, was the company's first product. For the next fifty years Varian Associates grew, renowned for its innovation. By 1999, the three primary business segments had grown enough to become independent organizations. Varian Associates split into three separate companies: Varian Semiconductor, Varian Medical Systems, and Varian, Inc., all retaining a name with a great legacy.

    Today, backed by our global team of product and applications experts, Varian is ideally suited to meet the mounting analytical challenges in these and other scientific communities:

    Biosciences

    Pharmaceutica

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