CUSTOMER SUPPORTC OMPREHENSIVE V ALIDATION PROGRAMWith a quality management system registered to the ISO 9001 standard,<strong>Beckman</strong> <strong>Coulter</strong> utilizes a qualified development process. The P/ACE series CE systems have been developed under this process to complywith all CE, UL, and CUL mark requirements. The Software ValidationPack provides basic information regarding development and performancetesting for the system software and can be utilized to supportcustomer validation programs. A trained field service engineer performsinstrument installation following a prescribed installation operationqualification protocol. In addition to installation, installation qualificationincludes conformity and delivery, basic training, and instrumentperformance testing. Optional operation qualification programs provideconvenient processes that ensure that the instrument is performing topublished specifications using calibrated testing equipment traceableto national standards.PART NUMBERDESCRIPTION144867 P/ACE MDQ and P/ACE 5000Installation Qualification (IQ): For original start-up of new system.Includes instrument unpacking, set-up, start-up installation environment.No charge with system purchase.144869 P/ACE MDQ OQ1721110 P/ACE 5000 OQ1Operation Qualification 1 (OQ1): Basic customer training and review oftutorial guide, performance verification, noise and drift tests, and documentation.No charge with system purchase.144870 P/ACE MDQ OQ2721111 P/ACE 5000 OQ2Operation Qualification 2 (OQ2): For on-going operation qualificationof a system. Performance verification, noise and drift tests, preventativemaintenance service and parts, software verification test and report, documentation,preventative maintenance checklist, service report andinstrument decal. OQ2 can be purchased as either an option to an existingservice agreement or as a reimbursable service.144688 P/ACE MDQ OQ3726140 P/ACE 5000 OQ3Operation Qualification 3 (OQ3): Comprehensive, full featuredoperation qualification support. Can be performed at installation oras an option to a service agreement. Includes preventative maintenanceservice and parts, software verification test and report, comprehensivefunction test of components, NIST standard traceability, documentationof engineer’s qualification, test equipment calibration, NIST standards,service report decal and preventative maintenance checklist.<strong>Beckman</strong> <strong>Coulter</strong>ContentsIndex42
CUSTOMER SUPPORTSoftware ValidationThe Software Validation Pack includes a description of intended use,product history, technical description, algorithms, product documentation,options, development environment, support policies and notices.PART NUMBERDESCRIPTION149989 32 Karat Software Validation144638 P/ACE MDQ Software Validation726124 Software Validation for Gold SoftwareVersions 8.1 and 8.2<strong>Beckman</strong> <strong>Coulter</strong>ContentsIndex43