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10 uw an ar an sa Poge 1 of 17 QUALITY MANUAL DOCUMENT NUMBER: QA1-001-G 7 April 2008 Capra Dae anes W2APLOY Sri Da ae 17 Apr Os PURPOSE & SCOPE This manual defines the operating practices for the out in accerdance with this document. iometrix Quality System. All quality act is conied RESPONSIBILITY The Quality Assurance Director is responsible fer ensuring that this procedure is accurate, understood and implemented effectively. INTRODUCTION The Quality System is defined as a series of procedures and supporting documentation established by this QUALITY MANUAL with the purpose of meintaining the qualily of Biomelrix operations. The Biometrix Quality System and QUALITY MANUAL are intended for use by Biometrix employees, Biometrix Customers and various regulatory agencies. Customers may use this manual to evaluate the suitablity of Biometrix as a qualified service vendor. The QUALITY MANUAL and Quality System are written to comply with the ISO'9001:2000 standard and FDA CGMPs, The QUALITY MANUAL is organized by processes identified by Biometrix as being key to its operation. PROPRIETARY NOTICE This document and all referenced and associated Biomettix documents, herectter referred to as the Quality System, are proprietary and confidential. On eccasion, the QUALITY MANUAL may be made available for review by businesses associated with or doing business with Biometrix. At oll times, the QUALITY MANUAL may not be Copied, cisclosed, or distributed to third parties without express written permission from Biometix, he services provided by Blomettix to a customer ore considered proprietary by both, Test reports, certificates and any other informatian generated for or about @ customer ore confidential and ore released to third parties only with the express written consent of the customer and Biometrix. COMPANY DATA Biometrix sin the business of providing high quality instrumentation services to the biotech ond pharmaceutical industries. Servicesinclude validation, Calibration, maintenance, commissioning and related services. swoiersonpbaburnted suk akoter Copy amo below ute. haem ot Come. Eirimoncmm,| MASTER Waa od Copy an Se as Rc, ab aan Soca Page2 of 17 QUALITY MANUAL DOCUMENT NUMBER: QAI-001-G EFFECTIVE DATE: 17 Apfil 2008 52 Biometrix's offices and laboratory space ore located at 127 Rivemeck Road. Chelmsford, MA 01824. The office may be reached at 978-654-6631 or 800-890-8909. The general fax number is 978-654-6640. The Biometrix webpage is 60 QUALITY AUTHORITY STRUCTURE £1 The Quality Assurance Director ensures that the Quality System is accurate, understood and effectively Implemented, For more information on the Biemetrix organization, please reference ORGANIZATIONAL HIERARCHY, document @A3-004, iain sere belowtiet ke Merle. W Copy dorp low Bue Mi on tee, Ti sean opatay coro ER Sevecson sa pers ano. apes wen R ‘emoso ham howe Copan CPEse me {ar acd Copy fore chove reac, Pa en nis Seen Poge So! 17 QUALITY MANUAL DOCUMENT NUMBER: QA1-001-G- EFFECTIVE DATE: 17 April 2008 7.0 BIOMETRIX KEY PROCESSES Biometrix Key Processes 60 ESTABLISHING QUALITY POLICY AND OBJECTIVES 61 Quality Policy 61.1 Blometrixis committed to achieving exceptional customer satisfaction. This is achieved by complying with the Quality System requirements while continuously shriving for improvernent. Quality Objectives are established and reviewed as described in the QUALITY MANUAL, 82 Quality Objectives 22.1 Biometrix maintains Quality Objectives used to measure compliance wi 's Quality Policy: "Achieve exceptional customer satisfaction * Achiave an exceptional level of training for customer service personnel lat top neon area mane dae UI Capy arp tow Bn Hen El 8 ‘a cearreets oniey aa conan penuonton erate Cmpestone pmo M a TER 1a Od ey Ha HE, EERE