185_0024_01
Contents
1. An IQ test report is printed and all installed software files are passed In case of an 21CFRpart11 support installation the advanced security feature is installed correctly Verified by customer 222444444n Henn Comments Deviations Y N x 8 of 11 IQ procedure ALEXYS software edition 1 Operational familiarisation The ALEXYS data system software has been designed for maximum functionality and ease of use Most of the operational issues are intuitive and do not need further explanation A few software features require a basic explanation Table IV Check Non conf ref Concept of a system and method file has been explained An example system amp method configuration has been build from scratch and explained A sample queue has been programmed and explained Explanation of manual integration and setting peak table and calibration curve has been given Batch reprocessing of a series of sample queue chromatograms has been performed Report and summary report functionality has been demonstrated Global preferences are explained Fo f If applicable the 21CFRpart 11 support features are explained Verified by customer cece ences Deviations Y N Comments Chapter 3 IQ certification 9 of 11 CHAPTER 3 IQ certification The installation has been performed in accordance to the Installation Qualification and has been carried out2. for installation The minimum requirements for basic configuration are listed below e 800 MHz Pentium computer with 256 Mb memory e Windows 98 Windows NT Windows 2000 or Windows XP operating system The 21CFR part 11 support version only operates under Windows 2000 or Windows XP Professional Edition using an NTFS disk partition e 15 Mb free space on hard disk is needed for installation only e 100 Mb free space on hard disk drive for data storage e Monitor resolution 1024x768 with 16 bit colour depth e One free RS232 port to connect the AC 100 interface e One free USB port to connect a USB license dongle Important installation information e Before inserting the USB dongle in the PC it is important that the USB license key drivers are installed e Always switch off AC 100 when starting up Windows or PC e When upgrading o Always uninstall previous ALEXYS version o Remove ALEXYS folder from PC or copy to a safe place o Download and install ALEXYS system files installer containing all new developed system files for a quick start Table Il Section installation amp Configuration in user manual s is noticed The PC amp hardware requirements for installation are met Installation of software is performed in accordance with user manual rev no Verified by customer cece ences Deviations Y N Comments Chapter 2 Installation Software IQ utility 7 of 11 Upon installati
3. to the satisfaction of both parties Designated operator has been trained and familiarised with the ALEXYS data system software during the installation Antec Leyden representative Technician name signature Customer authorised to sign Name amp signature ooccocccccncncoconocononencnnno 0 teeta eats tees ne neta een eeee eed Company dept Operator s trained for the ALEXYS data system Name amp initial Name amp initial Name amp initial Verified by customer c cece Deviations Y N Comments 10 of 11 IQ procedure ALEXYS software edition 1 Comments Verified by customer cece ences Deviations Y N Comments Chapter 4 Non conformance record 11 of 11 CHAPTER 4 Non conformance record Any case of non conformance found during installation should be documented and signed for acceptance or corrective action taken Verified by customer Looococnoccccccnccncnncnncnnis Deviations Y N Comments
4. ALEXYS data system IQ WE ALEXYS data system oix Eile Edit View Acquire Process Method Options Window Help clk 222 481 510 BEI el tl Tem 1S STEM flushedloop_tw Ale ES 4 M 0 calibrationt_07050401_tweederun mtw 1 run System Control Setup Measure 2 42 7 00 5 38 10 00 on Watch window SYSTEM flu Ed Arrange m DECADE II LC EC workstation Cell 1 0 00599 n m AC100 Interface chi 5 58 mV DECADE II LC EC workstation Vout 1 0 005 Y Icell 1 1 194 mA Ecellf1 0 60 v Temp 35 cio 21 flushedloop_twe S 125 21 13 20 00 1 00 22 flushedloop_twe S 15 0 22 14 20 00 1 00 23 flushedioop_twe M 0 23 0 20 00 1 00 z El System state Execution flushedloop_tweede_run smt vier_keer_calibreren_070504 que TF Shut down system after the queue finishes INJECT done SYSTEM T Close queue dialog window after the queue finishes Stat Pause Edit Y Close Help Edition 1 2006 185 0024 Identification 1 of 11 Identification The undersigned engineer certifies that he she is trained and qualified to perform an IQ on the ALEXYS data system software Performer Company Title Anted Leyden representative trained and qualified to perform PQ procedures The undersigned reviewer customer accepts that the above mentioned engineer is trained and qualified to perform an IQ on the ALEXYS data system software Reviewer Customer OOZ LL Name Signat
5. on ALEXYS versions 1 0 195 gt the ALEXYS data system automatically installs a software Installation Qualification utility to verify that all software components are correctly installed A report is generated and can be printed out see screen dump below BE Installation qualification ALEXYS data system Installation Qualification Test Report 2007 04 20 22 29 08 Installation qualification result PASSED Software installation folder C Program Files Alexys The software is installed with 21 CFR part 11 support Advanced security for 21 CFR part 11 is installed correctly File name Built 2006 06 14 09 59 46 2006 06 14 09 59 46 2006 06 14 09 59 44 2005 06 20 22 12 32 2003 10 14 16 04 36 2006 06 14 09 59 44 2006 06 14 09 59 46 2006 06 14 09 59 44 2003 10 14 16 04 36 2006 06 14 09 59 46 2006 06 14 09 59 46 2006 06 14 09 59 44 2003 10 14 16 04 36 2005 06 21 19 30 10 2006 06 14 09 59 46 2nne N6 14 NO 50 4A Modified 2006 06 14 11 59 46 2006 06 14 11 59 46 2006 06 14 11 59 44 2005 06 21 00 12 32 2003 10 14 18 04 36 2006 06 14 11 59 44 2006 06 14 11 59 46 2006 06 14 11 59 44 2003 10 14 18 04 36 2006 06 14 11 59 46 2006 06 14 11 59 46 2006 06 14 11 59 44 2003 10 14 18 04 36 2005 06 21 21 30 10 2006 06 14 11 59 46 SOMA MA 14 11 50 45 Status PASSED PASSED PASSED PASSED PASSED PASSED PASSED PASSED PASSED PASSED PASSED PASSED PASSED PASSED PASSED PASSEN Description Print report
6. operation and theory reference is made to the software user manual Verified by customer oocooccoccccccccnccnccnnnnnin Deviations Y N Comments Chapter 2 Installation 5 of 11 CHAPTER 2 Installation Unpacking and installation checks Inspect the transport box for possible damage as it arrives Immediately inform the transport company in case of damage otherwise she may not accept any responsibility The ALEXYS data system set includes following parts e Installation CD with ALEXYS data system and drivers e USB license dongle e User manual Carefully unpack the box and inspect it for completeness and for possible damage Contact your supplier in case of damage or if not all marked items on the checklist are included Table Non conf ref Delivery is in accordance with order is in Delivery is in accordance with order with order Delivery is undamaged All items on checklist s are included el User manual s is are included EI Any deviation observed must be documented in the non conformance record Verified by customer cooococcocconccnccnccnccnncnins Deviations Y N Comments 6 of 11 IQ procedure ALEXYS software edition 1 Installation procedure The full software installation procedure is described in the ALEXYS data system user manual Chpt Installation amp Configuration It is the users responsibility to meet the computer amp hardware requirements
7. ure Initials Companys eeraa aa a T nennen seen AISES SNA MA AA A TEE Owner designated authorized person Verified by customer cooococcocconccnccnccnccnncnins Deviations Y N Comments 2 of 11 IQ procedure ALEXYS software edition 1 Software Verified by customer cece ences Deviations Y N Comments Table of contents Table of contents Identification 1 Software 2 Table of contents 3 Introduction 4 Installation 5 Unpacking and installation checks 5 Installation procedure 6 Software IQ utility 7 Operational familiarisation 8 IQ certification 9 Comments 10 Non conformance record 11 Verified by customer 22444s444n nenn Comments Deviations Y N 3 of 11 4 of 11 IQ procedure ALEXYS software edition 1 CHAPTER 1 Introduction This document describes the installation procedure as advised by the manufacturer lt is a result from our interpretation of many regulations and laboratory practises All qualification checks have to be approved or should be marked n a if not applicable Any deviation observed must be documented in the non conformance record All relevant documents regarding system delivery an installation qualification must be filed together in one location As regulations and customer requirements may change manufacturer reserves the right to introduces changes without prior notice For details on functionality
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185_0024_01