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F26 ITS90 1.0 Appendix (PDF file)

1. Name Project function Date Signature Carl Tillman Validation Manager Reviewed by Name Project function Date Signature Project Manager Approved by Name Project function Date Signature Lars Goran Development Andersson manager Document ID Version Page 38 65 Error report 2 for F26 Temperature According to ITS 90 Template 1551 Utgava 2 0 Referens POP 1771 GAMBRO Renal Products Revision History Version Date Revised by Comments 1 Carl Tillman First issue Version Date Revised by Comments Version Date Revised by Comments 1 Description 1 1 Test Test case 4 3 17 Log in as Administrator and as Technician Click Probe and the click Create 1 2 Expected result OK to create new probe data as Administrator or Technician All data fields shall be clear apart from ID number Undefined whether it should be possible to create more than one probe with the same ID or whether ID can be left blank 1 3 Actual result OK to create new probe data as Administrator or Technician All data fields are then clear apart from ID number if any was entered Resulting anomalies errors 3 Itis possible to create more than one probe with the same ID 4 Itis possible to create a probe but leaving probe ID blank 2 Extent This is not a critical error and the outcome was never clearly specified 3 Decision No need of re test It is reco
2. 3 1 Software Design Specification The basic requirements from the SRS were further detailed in a software design specification See document Software Design Specification for F26 Temperature According to ITS 90 3 2 Supplier Qualification N A The system has been developed in house 4 Implementation 4 1 System documentation See document System Documentation for F26 Temperature According to ITS 90 4 2 System test report See document System test Plan Report for F26 Temperature According to ITS 90 3 error reports were generated None of these generated any critical errors but the reports should be used as an input for the next release of the software 5 Test No problems during this phase and no faults were detected acceptance tests 5 1 Acceptance test report See document System test Plan Report for F26 Temperature According to ITS 90 No error reports were generated 6 Preparation for Maintenance 6 1 User Manual No separate User Manual has been produced User instructions are included in the System Documentation for F26 Temperature According to ITS 90 6 2 Installation Training documentation Installation instructions are included in the System Documentation for F26 Temperature According to ITS 90 No training material has been produced Users are assumed to have the adequate computer knowledge to in stall and use the system without any formal training see Validation Plan for F26 Temperature According to IT
3. Validation Report Validation report for F26 Temperature According to ITS 90 Name Project function Date Signature Carl Tillman Validation Manager Reviewed by Name Project function Date Signature Project Manager Approved by Name Project function Date Signature Evert H kansson System Owner Name Project function Date Signature Christer Magnusson Quality Assurance Document ID Version Page 60 65 Validation report for F26 Temperature According to ITS 90 Template 1545 Utg va 2 0 Referens SOP 1540 GAMBRO Renal Products Revision History Version Date Revised by Comments 1 Carl Tillman First issue Version Date Revised by Comments Version Date Revised by Comments Table of contents 1 Concept and Planning Phase eeesseenneennvsnnvenuvennnennnennnennnennnnsnnnsnnnennnennnennnennnennnennnennnesnnesenesenneenee 61 1 1 Risk Analysis eeoeeeovvessvennvennvernnennneennnennneenneennennnnsnnnennnennnenenenennsnnnennnennnennnennnennnneneneneneenennnnenee 61 1 2 Validation Plan eeeeeevesevernvennvennnesnnnennnennnennnennnennnnnnnnennnenenennnnnnnnnnnnennnennnennnennnennnnennnennnenneenne 61 2 Requirement Phase eoerernverevesnvernnnennvennvennvennnennnennnennnennnennnnsennennnennnennnnnnnnnnnnenenennnenenesnnnsennennnennsee 61 2 1 Software Requirement Specification eeveenvvennvernvernnesn
4. 2 0 Referens SOP 1540 OG AMBRO Renal Products 8 Training and Rollout Strategy All users will be staff at the Calibration Group assumed to have adequate computer knowledge to install and use the software without any formal training The software and hardware are expected to be retired together Any future replacement system is likely not to have any need for external ITS 90 computations 9 System Maintenance The software F26 Temperature will be covered by the Change control described in POP 1771 10 Document Maintenance The Validation documents will be stored and version controlled according to SOP 1540 Document ID Version Page 9 65 Validation plan for 1 F26 Temperature According to ITS 90 Template 1546 Utgava 2 0 Referens SOP 1540 OG AMBRO Renal Products Appendix 3 Software Requirement Specification Software Requirement Prepared by Specification for F26 Temperature According to ITS 90 Name Project function Date Signature Carl Tillman Validation Manager Reviewed by Name Project function Date Signature Project Manager Approved by Name Project function Date Signature Evert Hakansson System owner Document ID Version Page 10 65 Software Requirement Specification for 1 F26 Temperature According to ITS 90 Template 1554 Utgava 2 0 Referens SOP 1540 OG AMBRO Renal Products Revision History Version D
5. Passor Report ID a Verify that all requirements in All data types are correct the SRS 3 1 1 are met for with regard to type each data field of the user length and list items data name in full user name password and operator level Document ID Version Page 25 65 System test Plan Report for 1 F26 Temperature According to ITS 90 Template 1544 Utgava 5 0 Referens SOP 1540 GAMBRO Renal Products Test description Expected results Result Error Pass or Report ID Verify that all requirements in All data types are correct the SRS 3 1 1 are met for with regard to type each data field of the Pt 25 format number of data ID number calibration decimals and interval number R0 01 a t gt 0 01 b t gt 0 01 a t lt 0 01 and b t lt 0 01 Verify that ID number is ID number is displayed in displayed with large fonts a large font and is easy Font size cannot be to read determined from screen Verify that temperature is Temperature is displayed displayed with large fonts and in a large font and is 4 decimals Font size cannot easy to read be determined from screen 4 2 5 Graphic user interface The software has a pe graphic user interface Document ID Version Page 26 65 System test Plan Report for 1 F26 Temperature According to ITS 90 Template 1544 Utgava 5 0 Referens SOP 1540 GAMBRO R nal Products 4 3 Functions Purpose and descriptions The purpose of this test case is to
6. Temperature According to ITS 90 Template 1547 Utg va 3 0 Referens SOP 1540 GAMBGRO Renal Products 4 Tests 4 1 Interface Purpose and descriptions The purpose of this test case is to verify that the software can be run on a PC as specified in the SRS Test description Expected results Result Error Pass or Report ID Test that the software can be The software can be run on a PC as specified in started the SRS Only start up is tested 4 2 Input Purpose and descriptions The purpose of this test case is to verify that the software handle input according to specifications Test of requirements for data type format and length and intervals will be tested in the System test Test description Expected results Result Error perpe Fail m cine eee TT the PCs keyboard data fields 4 2 2 Start the software and verify Displayed temperatures that data from the F26 can be on the F26 and in the read software are identical Document ID Version Page 44 65 Acceptance test Plan Report for 1 F26 Temperature Template 1547 Utgava 3 0 Referens SOP 1540 GAMBRO Renal Products 4 3 Output Purpose and descriptions Syftet med dessa tester ar att verifiera att programvaran visar Onskad information Test description Expected results Result Error Pass or Report ID Verify that temperature is Temperature is displayed displayed with at least 4 with at least 4 decimals decimals Nr of decimals shown Ver
7. This includes all data as specified in section 3 1 1 of the SRS User data shall be encrypted so that no login information can be read directly by an individual i e without manipulating the data As stated in section 2 2 Assumption in the SRS there is no requirements for any data backup 5 Security All requirement for security functionality has been specified in the section 3 Functions above 6 Alarms N A The software does not support any Alarm functions 7 Error Handling Error and warning messages shall be presented for the user as messages in dialog boxes Definition of errors and warnings are as follows Type Error Cause Message Warning Error in the communication with the This is handled by standard E F26 functionality in LabView Therefore no specific requirements for which message to be shown Problem in reading or writing to This is handled by standard E configuration file functionality in LabView Therefore no specific requirements for which message to be shown A Pt 25 is selected with a calibration Probe is due for calibration W date that has expired A Pt 25 is selected with a calibration Another probe has a later W date that isn t the latest among the registered probes calibration date Document ID Software Design Specification for F26 Temperature According to ITS 90 Template 1553 Version Page 21 65 Utgava 2 0 Referens SOP 1540
8. 3 User and Function Requirements 3 1 Interface The software shall be possible to run on a PC with the following configuration Pentium compatible PC 100 MHz or higher 32 MB RAM or more 100 MB free space on hard drives or more Windows 95 Pre installed GPIB hardware and software from National Instruments Pre installed LabVIEW Run TIME Engine 6 1 or higher versions User interface Document ID Version Page 13 65 Software Requirement Specification for 1 F26 Temperature According to ITS 90 Template 1554 Utgava 2 0 Referens SOP 1540 OG AMBRO Renal Products The user shall be able to work with the software through a graphical user interface Help texts shall be displayed when the mouse pointer is above input and output objects in the interface 3 1 1 Input Pt 25 data The following information shall be stored for registered Pt 25 thermometers Length Label Description Type format precision Interval ID number Gambro s internal ID number Text gt 4 Calibration date Date for last calibration Date YYYY YYYY MM DD 2000 2040 MM 1 12 DD 1 31 Certificate Latest certificate number from Text 10 number SP RO 01 Resistance at the triple point Numeric Float 5 decimals for water 0 01 C a t gt 0 01 C ITS 90 coefficient Numeric 5 decimals Scientific b t gt 0 01 C ITS 90 coefficient Numeric 5 decimals Scientific a t lt 0 01 C ITS 90 coefficient Numeric 5 de
9. 90 5 System Acceptance Criteria The system will be considered as validated when all criteria in the SRS and the SDS are fulfilled and all validation documents have been approved 6 Validation Documents Responsibility by isk Analysis Validation Plan SO QA i secati stem Requirement Specification secati y c eee HEER ceptance Test Plan Report oser ystem Design Specification ystem test Plan Report ystem test Plan Report rror report System stallation Manual ser Manual 3 cceptance Test Plan Report rror report Acceptance Preparation Validation Report secati PM SO QA for Maintenance Table 1 Validation documents and roles responsibility SO System Owner QA Quality Assurance PM Project Manager Dev Development Manager No separate Installation Manual will be produced Instructions for installation will be included in the System Documentation for F26 Temperature According to ITS 90 No separate User Manual will be produced The software contains some help texts and users are assumed to be able to operate the software without specific instructions see section 8 below 7 Validation Report The validation report is the summary of all test results The Validation Group will also provide recommendations to accept reject the software based on the acceptance criteria Document ID Version Page 8 65 Validation plan for 1 F26 Temperature According to ITS 90 Template 1546 Utgava
10. E E E E S A A susscosssososesses 24 2 Test environment 5 0 5s csseccseccsscesssscossscssssssosscacesscecesosedcsscosscocesseecesecesssocesosedssevesesooosssesssocesessosseesee 24 3 Lest TOS EN 24 4 EE NS 25 4 1 Installation sususrsssesressasesvesvaseseessnaeevevssansnesesseeeesensesveesaaneressneessesenseneekvnseenessseesvnssanesvessasesees 25 4 2 Architecture Interface nsssnenenunsnennnunenennnenenenennsenenenusenenennsenenenenenenennnenenenenenenennseneneneneeenen 25 4 3 FU CUIOMS secicssccccccsscseeccsssocedcsscecescsssesscusocoseessesesecosoesececosyoseseeoes sesusossusevesse cesses cs susvevssseseseescese 27 4 4 Data Architecture Data Structure ccccccccscscscscscscscccccccececccccscccccececececececececececececececes 32 4 5 SOCUTILY eeveeenreenreenerenneennennnennnesnnesnnesnnennneennnennnenenennnennnnnnnenenenennennnennnennnennnennnennnnnnnnennneneneneneeene 32 4 6 EE EE SS 32 4 7 Error Handling eeeoovesvvennvernvernneennennnneennennnennnesnnennnesnnnennnennnenenennnenenesnnnsnnnennnennnennneennennnennneene 33 4 8 Back up Restore eoesesnverevernvennnennnennnnnnnnennnennnennnennnennnnnnnnnnnnenenenenenennnnnnnnnnennnennnennnennnennennneene 33 49 Stress Worst case fest i sscsscasestcaseaversevsastsceseseesseveosesceseover ssveesesesesvessesceuebeesecverseseadessoseeeed sss 34 4 10 Other ei ERE PEIEE EAE E AEE E ET AEE A seeees sa sceess E T 34 5 Errors during the test eessvoennvenvvevrennrennrennnennnennnennnnnennennne
11. OG AMBRO Renal Products The user is required to accept each displayed error warning message 8 Installation instructions See System Documentation for F26 Temperature According to ITS 90 for installation instructions Document ID Version Page 22 65 Software Design Specification for 1 F26 Temperature According to ITS 90 Template 1553 Utgava 2 0 Referens SOP 1540 GAMBRO Renal Products Appendix 5 System test Plan Report System test Plan Report Prepared by for F26 Temperature According to ITS 90 Name Project function Date Signature Carl Tillman Validation Manager Plan reviewed by Name Project function Date Signature Project Manager Report reviewed by Name Project function Date Signature Project Manager Plan approved by Name Project function Date Signature Lars G ran Development Andersson Manager Report approved by Name Project function Date Signature Lars G ran Development Andersson Manager Document ID Version Page 23 65 System test Plan Report for F26 Temperature According to ITS 90 Template 1544 Utg va 5 0 Referens SOP 1540 GAMBRO Renal Products Revision History Version Date Revised by Comments 1 Carl Tillman First issue Version Date Revised by Comments Version Date Revised by Comments Table of contents 1 Tt OGWCUIOM EE
12. changes in probe data edit create or erase any after button OK is record Click button OK pressed Click Probe again to verify stored that changes have been 4 3 22 Log in as Operator Click Operator cannot create Probe and verify that neither new records or erase old Create nor Erase can be ones Buttons are pressed deactivated 4 3 23 Log in as Administrator OK for all users to enter Technician and Operator normal mode select a probe and click OK Verify that the software runs in its normal mode showing temperature values 4 3 24 Continue from 4 3 23 and OK for all user levels to verify that any user from any press button Probe level Administrator Technician and Operator can press the Probe button in normal mode Document ID Version Page 30 65 System test Plan Report for 1 F26 Temperature According to ITS 90 Template 1544 Utgava 5 0 Referens SOP 1540 GAMBRO Renal Products alls description Expected results Result Error Pass or Report ID pe 25 Continue from 4 3 23 and OK for all user levels to verify that any user from any __ press button Password level Administrator Technician and Operator can press the Password button in normal mode 4 3 26 Continue from 4 3 23 and OK for all user levels to verify that any user from any press button Log in and level Administrator execute a new log in Technician and Opera
13. in the table below Actions that need to be taken will be described in the Error report If changes in the software will be necessary the software or parts of the software need to be retested Errors Test description Expected results Actual Error Result Report ID Document ID Version Page 50 65 Acceptance test Plan Report for 1 F26 Temperature Template 1547 Utgava 3 0 Referens SOP 1540 GAMBRO Renal Products Appendix 8 Prepared by System Documentation System documentation for F26 Temperature According to ITS 90 Name Project function Date Signature Carl Tillman Validation Manager Reviewed by Name Project function Date Signature Project Manager Approved by Name Project function Date Signature Lars G ran Development Andersson Manager Document ID Version Page 51 65 System documentation for F26 Temperature According to ITS 90 Template 1543 Utg va 2 0 Referens SOP 1540 GAMBRO Renal Products Revision History Version Date Revised by Comments 1 Carl Tillman First issue Version Date Revised by Comments Version Date Revised by Comments Table of contents 1 Introduction seis ovesisssscescscssvevssiosseccsesoovvestevneceesoovesiecnsbassesoosdassesenusessoosvesscssbessesestssenendedvossosseseess 52 2 System Architecture resnnesnvvenevennvennvennnennnennnennnennnnnnnnnennennnennennnennnnnnnn
14. level Administrator to other level 4 3 9 Log in as Administrator Technician and Operator Click Password Change password and enter The software accepts the the same password with at new password least 4 characters twice in the two field Change password and enter The software detects a passwords with at least 4 mismatch and displays characters but be sure the message and a cleared password are not identical password dialog box once again 4 3 12 Log in as Administrator OK for users at all levels Technician and Operator to click button Probe Click Probe 4 3 13 Following 4 3 12 select a The corresponding data probe in the list Try for for the chosen probe is Administrator Technician and shown at all user levels Operator Document ID Version Page 28 65 System test Plan Report for 1 F26 Temperature According to ITS 90 Template 1544 Utgava 5 0 Referens SOP 1540 GAMBRO Renal Products Test description Expected results Result Error Pass or Report ID 4 3 14 Log in as Administrator The software detects the Technician and Operator expired date and Click Probe and select a displays the warning probe with an expired message Probe is due calibration date for calibration 4 3 15 Log in as Administrator The software detects Technician and Operator another probe with a Click Probe and select a later calibration date and probe with a calibration date displa
15. levels access levels Administrator Technician and Operator Verify that only Administrators Only Administrators can can manage user data manage user data For other access levels the Users button is deactivated Verify that only Administrators Only Administrators and and Technicians can manage _ Technicians can manage probe data probe data For Operator access level the Erase and Create buttons are deactivated Document ID Version Page 48 65 Acceptance test Plan Report for 1 F26 Temperature Template 1547 Utgava 3 0 Referens SOP 1540 GAMBRO Renal Products Test description Expected results Result Error Pass or Report ID Verify that neither user names Neither user names nor nor passwords can be read passwords can be read without data manipulation in directly in an editor the ini file 4 9 Alarms N A 4 10 Errors Test of Error handling is done as a part of the system test See System tests 4 3 14 4 3 15 4 7 1 and 4 7 2 Test description Expected results Result Error Pass or Report ID Fail 4 10 1 Verify that the software has The software can handle functionality for error handling errors 4 11 Other Requirements N A Document ID Version Page 49 65 Acceptance test Plan Report for 1 F26 Temperature Template 1547 Utgava 3 0 Referens SOP 1540 GAMBRO Renal Products 5 Errors during the test The errors that occurred during the tests are described
16. support any alarm functions 8 Error handling The software shall communicate errors and warning messages to the user Situations that shall trigger such messages are Errors Error in the communication with the F26 Read write error for configuration data Warnings Calibration date for chosen Pt 25 has expired Calibration date not the latest there is another Pt 25 with a newer calibration date See warning messages in section 0 Functions above 9 Installation This software is designed for installation on a PC as specified in section 3 1 of the SRS The installation package includes the following files install msi InstMsi exe InstMsiW exe setup exe setup ini Document ID Version Page 58 65 System documentation for 1 F26 Temperature According to ITS 90 Template 1543 Utgava 2 0 Referens SOP 1540 GAMBRO Renal Products Run the setup exe file That will start an Installation Wizard Follow the instructions on the screen in order to complete the installation 10 Third party components Component Description LabView Run Time Engine The system is developed using LabView 6 1 In order 6 1 to run the software the LabView Run Time Engine has to be installed prior to the F26 Temperature software Document ID Version Page 59 65 System documentation for 1 F26 Temperature According to ITS 90 Template 1543 Utg va 2 0 Referens SOP 1540 GAMBRO Renal Products Appendix 9 Prepared by
17. verify that all specified functionality is contained in the software Test description Expected results Result Error Pass or Report ID At log in the user shall be A dialog box is displayed prompted to enter user name where user name and and password in a dialog box password can be entered Entered user name and or The software displays an password that is not correct appropriate message and displays the login dialog box once again Log in as Administrator Click It is possible to active button Users Manage data for user profiles by clicking a button labelled Users Log in as Operator and as Button Users is Technician Try click button deactivated Users Log in as Administrator Click It is possible to erase button Users select a user users registered in the in the list of registered users _ user list and then click Erase Log in as Administrator Try to It is only possible to erase all administrators erase all but one administrator Document ID Version Page 27 65 System test Plan Report for 1 F26 Temperature According to ITS 90 Template 1544 Utgava 5 0 Referens SOP 1540 GAMBRO Renal Products Test description Expected results Result Error Pass or Report ID all fields name in full users and try to edit user data user name password and level all users but one Try to Administrator to other change the level from
18. 1 certificate RO 01 ohm 0 00000 4 0 0000000E 0 E gt 0 01 b 0 0000000E 0 a 0 0000000E 0 t lt 0 01 C b 0 0000000E 0 Reset This will reset any changes made before confirmation by clicking OK Pressing the OK button will save all changes and the software proceeds to the main screen It is then not possible to Reset any changes Document ID Version System documentation for 1 F26 Temperature According to ITS 90 Template 1543 Utgava 2 0 Page 56 65 Referens SOP 1540 GAMBRO Renal Products When a user is logged in as Operator both buttons Create or Erase shall be deactivated and thus not allow new records to be created or old ones to be erased Calculate temperatures according to ITS 90 When no other windows are displayed other than the main window the software shall continuously read calculate temperatures and display temperatures This is the default mode of the software For repetition rate see section 3 3 1 in the SRS m Temperature C Probe data 5 7010 e Mom calibration date 12002 E 21 certificate MTv F200584 Resistance ohm 26 00002 RO 01 f ohm 125 42356 2 0883940E 4 User Lars G ran Andersson t gt 0 01 1 7688640E 4 t lt 0 01 C b 1 6809260E 6 When the software is executing in default mode as defined above any users with a high enough access right shall be abl
19. 1540 GAMBRO Renal Products Revision History Version Date Revised by Comments 1 Carl Tillman First issue Version Date Revised by Comments Version Date Revised by Comments Table of contents 1 Introduction ueresevennvennneennesnnnvnnnennnennnennnennnennnnennnennnennnennnennnnnnnesnnnennnennnennnennnennnnnnnennnnennnennnnenneenee 43 2 Test environment ereserernvennvennveennnennnennvennnennnennnennnennnennnesnnnnennennnennnennnennnnenunenenennnennnennnnsunnennnennsee 43 3 Test results evevoreververevernnnevnennnennnennnrsnnrnnneennnennnennnennnnnnnennnenennennnennnennnennnnnnnnennnennnenenenennnennevnnenesee 43 A OSES RE NM SE NERE SE NE Sr MEN ee 44 4 1 Interface ss dsccccssssecacesiaesececsssceseccssussuses ssasecceseuseccssussaces need tsesndeuessanesiesssadssaseenteaseesiecesieeossacesess 44 4 2 Daana aaae A E E T S 44 4 3 QUT t i i EAEE TT E 45 4 4 Functions suissmsssssearssssenssssssernssanesnnsssnnnnndessdenedven cteacceccstecsseadececessiesooscesiacoseesissscneassacss easiacseece 46 4 5 Performance Requirements erersvernvernvernnenennennnennennnnnnnnnnnnnnnnennnnnenennnennnnennnennnennnennnennneenenene 47 4 6 Limitations eeeoeevesvvensvennvennvennnesnnesnnneennennnesnnennnennnnenenennnenenennnesnnnsnnnennnennnennnennenennnennnennnnenneenee 47 4 7 Design Constraints ressressvessvesnnennnnennnenneennennnennnnennnnnnnennnnnnnnnnnnnnnnennnennnennnennnennnnennn
20. 40 GAMBRO R nal Products 4 7 Error Handling Purpose and descriptions The purpose of this test case is to verify that the software can handle error Warnings are tested in section 4 3 above Test description Expected results Result Error Pass or Report ID a Enter normal operation Error message is shown measuring mode Break the indicating a broken communication ee the communication with the PC and the F26 by shutting measuring unit dow3n the F26 Create a backup copy of the Error message shown ini file Start the software and unknown since depen enter into normal mode Erase dence on LabView the original ini file Try to create a new user 4 8 Back up Restore N A Document ID Version Page 33 65 System test Plan Report for 1 F26 Temperature According to ITS 90 Template 1544 Utg va 5 0 Referens SOP 1540 MGAMBRO Renal Products 4 9 Stress Worst case test Purpose and descriptions The purpose of this test case is to verify that the software is not limited to the number of users and probes specified in the SRS Test description Expected results Result Error Pass or Report ID i Create data for 10 probes The software is not limited to the number of probes specified in the SRS 3 probes but can handle a larger amount of probe data Create 10 user accounts The software is not limited to the number of user accounts specified in the SRS 5 accounts but can handle a larger numb
21. 553 Utgava 2 0 Referens SOP 1540 GAMBRO Renal Products User requirements for input and output data is listed in SRS for F26 Temperature According to ITS 90 Additional design requirements for user communication Label Input Output Font size Colours ID number Input Arial 35 points Black text light yellow background Temperature Output Arial 50 points The user interface is consists of a main windows always shown in the background and two further windows that can be activated a Select or Edit Pt 25 Probe Data window and a Configure Users window Each of these windows contains one or more buttons for activation of functionality In addition to these windows a number of dialog boxes will be shown for e g input of passwords or display of warning messages References For further information about the system design and interface see the document Software Design Document for F26 Temperature According to ITS 90 This document is an auto generated design description based on the code input in the LabView development environment 3 Functions The software shall support the following high level functionality 4 Manage data for user profiles 5 Manage data for Pt 25 thermometers 6 Calculate temperatures according to ITS 90 These functions are further detailed below Login Manage data for user profiles At log in the user shall be prompted to enter user name and password in a dialog bo
22. NT Techn Report 535 Software Validation Report Page 1 of 65 Software Product F26 Temperature According to ITS 90 References and annexes All external documents if any must be dated and signed Document Name Filename I Risk Analysis Risk Analysis F26 Temperature 2 Validation Plan Validation plan F26 Temperature 3 Software Requirement Specification SRS F26 Temperature 4 Software Design Specification SDS F26 Temperature 5 System test Plan Report System test F26 Temperature 6 System test Error reports Error report 1 2 and 3 7 Acceptance test Plan Report Acceptance test F26 Temperatue 8 System Documentation System documentation F26 Temperature 9 Validation Report Validation report F26 Temperature 10 Software Design Document Note 1 SDD F26 Temperature Note 1 The Software Design Document is not entirely included too large In order to to make the Appendices easier accessible they are copied into this document which is the primary appendix to the main validation report file Gambro Nordtest F26 ITS90 1 0 Report doc In a local environment it could be easier to retain the original document files as dynamic links Table of contents of Appendices Appendix 1 Risk analysis EEE 2 Appendix 2 Validation Planuuuuuaesmsemsenuememeisennneinjeieueeenviis 5 Appendix 3 Software Requirement Specification sccccsssscsssesssecssesscsesssessees 10 Appendi
23. S 90 Document ID Version Page 62 65 Validation report for 1 F26 Temperature According to ITS 90 Template 1545 Utgava 2 0 Referens SOP 1540 GAMBRO Renal Products 7 Change control The software follows change control POP 1771 8 Retirement The software follows the general Retirement plan For further information see Change control POP 1771 9 Conclusions The recommendation is that the software F26 Temperature According to ITS 90 version 1 0 is approved from a validation point of view It is also recommended that the error reports 1 3 from the system tests are used as an input for code correction in the next release of the software Document ID Version Page 63 65 Validation report for 1 F26 Temperature According to ITS 90 Template 1545 Utgava 2 0 Referens SOP 1540 GAMBRO Renal Products Appendix 10 Software Design Document Software Design Document Prepared by for F26 Temperature According to ITS 90 Name Project function Date Signature Lars G ran Development Andersson Manager Revision History Version Date Revised by Comments 1 Lars G ran First issue Andersson Version Date Revised by Comments Version Date Revised by Comments Document ID Version Page 64 65 Software Design Document for F26 Temperature According to ITS 90 GAMBRO Renal Products 1 Introduction This document has been auto generated from the so
24. a 1 2 1 2 2 3 1 3 2 x 4 to calculate the risk We have 5 2 1 4 1 x2 18 5 X 65 Document ID Version Page 4 65 Risk Analysis for 1 F26 Temperature According to ITS 90 Template 1552 Utg va 3 0 Referens POP 1772 GAMBRO Renal Products Appendix 2 Prepared by Validation Plan Validation plan for F26 Temperature According to ITS 90 Name Project function Date Signature Carl Tillman Validation Manager Reviewed by Name Project function Date Signature Project Manager Approved by Name Project function Date Signature Evert H kansson System owner Name Project function Date Signature Christer Magnusson Quality assurance Document ID Version Page 5 65 Validation plan for F26 Temperature According to ITS 90 Template 1546 Utg va 2 0 Referens SOP 1540 OG AMBRO Renal Products Revision History Version Date Revised by Comments 1 Carl Tillman First issue Version Date Revised by Comments Version Date Revised by Comments Table of contents 1 Introduction esesevoenvvvnvvvenrsnnrennnennnenenenennnnnnnnnnsnnnennnennnennnennnennnennnnennnennnennnnnnnennnennnennnennnnnnnennnennnnenen 2 Roles and responsibilities revevevevervenevenvnennennnennnennnennennnnennvennnennnennnennnennnennnennnesennsenneenneennennnenen 2 1 Validation Team esesevesevesnvesnne
25. al calculation confirms that the displayed temperature is correctly shown with at least two decimals Manually calculated temperature gt Page 46 65 Referens SOP 1540 GAMBRO Renal Products Test description Expected results Result Error Pass or Report ID Read resistance Read ee 4 5 Performance Requirements The purpose of this test case is to verify that all performance constraints are fulfilled Test description Expected results Result Error Pass or Report ID Fail 4 5 1 Verify that temperature values Updating frequency gt 1 can be updated on the screen Hz at least with a rate of 1 Hz ia ial S be registered users can be registered 4 5 3 Verify that at least 3 probes Probe data for at least can be registered five probes can be registered 4 6 Limitations N A 4 7 Design Constraints N A Document ID Version Page 47 65 Acceptance test Plan Report for 1 F26 Temperature Template 1547 Utgava 3 0 Referens SOP 1540 CS AMBRO Renal Products 4 8 Security Purpose and descriptions The purpose of this test case is to verify that all security requirements are fulfilled Test description Expected results Result Error Pass or Report ID Verify that the software is The software can not be password protected used for any measurements or management of data without a login using user ID and password Verify that the software The software supports supports three different the access
26. ate Revised by Comments 1 Carl Tillman First issue Version Date Revised by Comments Version Date Revised by Comments Table of contents 1 RU eee ee ee er 11 2 QV ER VICW NN NO NE NE 12 2 1 System Perspective rssrasenasenaennnennnennnesneennnennnennnennnnnnnenenenennennnennneennennnennnennnnsnnnnnenenenenenneene 12 2 1 1 General architecture sixciscssch bcc scaneedevacdectestontteeteegenes svamucteveanenae oventues Uecdesesdsuaueabenndes sesuuenteonsnesens 13 21 2 General Constramtsusrvavrusmkvandeknanniermevan delene rater ide 13 2 2 Assumptions and Dependencies resnvesvvennrennnnnnnennnennnennnnnnnnennnennnennnennnennnennnennnnsnnenennsenneensee 13 3 User and Function Requirements sessssvessnnvennnnvsnevevnnnvnnnnnvennnnnsnnvennnnvnnnnvsnnnnnsneneennnensnnnvensnneenene 13 3 1 DNC PLACE vis seesiscsecctsssssevecscenssvcsseseovesecussvedtesseneceesoosusssesetecescsocvecues snes csovovdsauusenessoeseeesovensdea coosses 13 3 1 1 Input 14 3 1 2 OUP UE aioe ada weoxe ade cden ci sdancancddacs avin denbedosazesesned T EEE EE a E AE A EE ae 15 3 2 FUNCUONS veinsisssssccssssssossesesssssestesenscesesestsstevvsecsccossssdeseisssecesascgeseesssosssdecessbeeesteessdebessenssecssssses 15 3 3 Performance Constraints soiscsscccisccoccsssssesnssosenssssssosvessoseossesconsosescvesooseseuseesecsosesdoveessesscoosses 15 3 3 1 Performance Requirement cccscccssecsssesseceseceseceseeeseeseeseneceseeseeseeeseneseseeesee
27. cimals Scientific b t lt 0 01 C ITS 90 coefficient Numeric 5 decimals Scientific For the numeric data the value range covered by standard variables in LabView is more than enough Hence there are no further requirements with respect to value range User profile The following information shall be stored for a registered user Length Label Description Type format precision Other Name in full First name and family name Text gt 20 User name Unique user code Text gt 10 Password User password Text gt 12 Operator level Pre defined user levels that List Pre defined can be chosen from a list levels Administrator Technician Operator GPIB data The software shall be able to read resistance data from the F26 Document ID Version Page 14 65 Software Requirement Specification for 1 F26 Temperature According to ITS 90 Template 1554 Utg va 2 0 Referens SOP 1540 GAMBRO Renal Products 3 1 2 Output The software shall present the following data Temperature o The software shall present calculated temperatures with 4 decimals Resistance User s first name and family name Pt 25 data o The software shall present calibration data for chosen Pt 25 thermometer User guidance o Tip strips help texts displayed when hovering the mouse over objects shall be used where appropriate 3 2 Functions The software shall support the
28. display the change password dialog box once again Manage data for Pt 25 thermometers All users shall be able to activate select probe by clicking the button Probe in the main window All users shall be able to select a probe from the list of registered probes in the Select or Edit Pt 25 Probe Data window When a probe is selected the corresponding data for that probe shall be displayed Ifa probe is selected the software shall display a warning if the calibration date is expired see section 7 below Ifa probe is selected and any other probe is registered with a later calibration data the software shall display a warning see section 7 below Administrators and technicians shall be able to edit data for any probe This includes the following data The calibration date for the latest calibration certificate Calibration certificate number The resistance at the triple point of water RO 01 The coefficients a and b for temperatures gt 0 01 C The coefficients a and b for temperatures lt 0 01 C Administrators and technicians shall be able to create records for new probes by clicking the button Create After a new record is created empty data fields shall be displayed and the user shall be able to edit data as above Administrators and technicians shall be able to delete registered probes by clicking the button Erase Administrators and technicians shall be able to reset changes b
29. e to activate the other functions as described above The software shall calculate temperatures according to the ITS 90 This shall be done by reading resistance values from the F26 and converting them to ITS 90 temperatures by using the inverse reference functions 9b and 10b as well as the deviation functions 12 and 13 defined in ITS 90 4 Data Architecture Data Structure The software is not based on any database but rather a number of defined variables For specification of input and output data see the Software Requirement Specification for F26 Temperature According to ITS 90 For specification of internal variables see the System Design Document for F26 Temperature According to ITS 90 Document ID Version Page 57 65 System documentation for 1 F26 Temperature According to ITS 90 Template 1543 Utgava 2 0 Referens SOP 1540 GAMBRO Renal Products 5 Client Server N A the software is not developed according to Client Server principles 6 Security The software shall be password protected Users shall be able to log in at 3 different user levels with access rights at each level according to Operator level Access to Pt 25 data Access to User profiles Operator Read No access Technician Read Write No access Administrator Read Write Read Write User ID and passwords must not be stored in a format directly readable for humans e g unencrypted text files 7 Alarm N A The software does not
30. enenenennnnnnnnennnennnennnennnennnnnnnennnnenenenenennnennennnennnennnennnnnnnnennnennnneee 63 8 Retirement ccccssicccccsceccccseeciecsieccsiccsesesteascaetecsacesitessecestecosscctssccsedecssonsteesseassansessiaesescasecssccesiteesteceseae 63 9 Conclusions rseresnvsnrnerernvnnnnnvennvnnnvenennrennnnnnsevennennnsenennrnnnnnnnnnnserennennnseneneennnsnnenevennennseneneenenennennneene 63 1 Concept and Planning Phase The software was developed internally by the Calibration Group Monitor Division 1 1 Risk Analysis A risk analysis was conducted in accordance with SOP 1540 The risk analysis gave a total risk of 18 points on scale 5 to 65 points See document Risk Analysis for F26 Temperature According to ITS 90 1 2 Validation Plan A validation plan was documented in accordance with SOP 1540 and was subseqeuntly followed during the validation work See document Validation Plan for F26 Temperature According to ITS 90 2 Requirement Phase No problems during this phase Document ID Version Page 61 65 Validation report for 1 F26 Temperature According to ITS 90 Template 1545 Utg va 2 0 Referens SOP 1540 GAMBRO Renal Products 2 1 Software Requirement Specification A software requirement specification was documented including both user requirements and functional requirements See document Software Requirement Specification for F26 Temperature According to ITS 90 3 Design and or Purchase No problems during this phase
31. ennnennnennnennnnnnnennnnnnnnnnnnennnnnnnennnnnnnnennnennnennnesnnennnennnnennnennnennneenee 2 2 Responsibilities of the Validation Group members eserenerennvennvernnesnnesnnesnnrenneennrennnennneenneeene 3 Validation Approach cesoosevevevennvennnennneennnennnennnennnennnennnennenennnennnennnennnennnennnennnneennennnennnesnneenneneneene 3 1 NS SE 3 2 SCOPE ssaiisccssacedssssrsbssonsssstecscushusschssostesseuesissvastessecsoutedseusescessesuussosassivensesuls cosvesveusseeussesenasvecsecstkes 3 3 Dependences wis ssnitssessssssssscnstssavasesccssccudsseannseevesceuassoannddesdessuassoenaddsenscskusseswassonsacsuisssosesseoessoutes A CMOS EE E E E E sued ssacsoscsebssvesssscaccsseassssconsesssesseasesceseesssuosessecessecs 4 1 System Test Plan Report esnveenvornvvenvvennvennnennsennesennennnennnesnnesnnesnnnennnennnenenennnennnnsnnesnnnennnenneee 4 2 Acceptance Test Plan Report sessvesevesevennveennnennnennnennnesnneennrnnnnennnennnennnennnennnenenenennennneeneenee 5 System Acceptance Criteria eessesenrsenrennvennvennnennnannnnnnnnennnennnennnesnnennnnennnennnennnennnennnenenenennennnennnenen 6 Validation Documents reenveevnvennvennvennnennnennnennnennnnsnnnennnennnennnennnennnennnnennnennnennnennnennnesennsenneennenenenen 7 Validation Report eeresvovevevevneenneenneennvennnnnnnennnennnennnenenenennnnnennnnsnnnennnennnennnennnennnesnnnennnennneennennnnenne 8 Training and Rollout Strategy cssesesrerevevevenevavevannnnsnnnennnen
32. ennnneneeeeee 47 4 8 Security seonesenrvenesnnnennnennnennnennnennnennnennnnennnennnennnennnennnenennnnnnnennennnennnennnennnnnnunenenenennnenenvnnennnenesee 48 4 9 AlArms AE T 49 4 10 Errors and warnings eesvesnvvennrsnneennnennnennnennnnnnnnnnnnnnnnennnennnennnnnnnnnnnnennnennnennnennnennenennnennnennnennee 49 4 11 Other Requirements eevnvernvernvernnennnneennennnennnennnennnnnnnnnnnnnnenennnennnnennnennnennnennnennnennnnennneeneneneenene 49 5 Errors during the test eeesevennvennvennvennvennnnennnennnennnennnennnennnnennnennnennnennnennnesnnennnnsennsenneennennnesnnennnneee 50 1 Introduction This document is used for the acceptance test of the software F26 Temperature According to ITS 90 and will include both test plan and test results The requirements from the Software Requirement Specification have been converted to test cases and test criteria The references and definitions are described in SOP 1540 2 Test environment The tests were conducted on a PC meeting the requirements as stated in the SRS for F26 Temperature According To ITS 90 section User and Function Requirements The test environment also included the following equipment F26 ID number 28 Pt 25 ID number 71 or 80 3 Test results When the tests are finished the errors will be reviewed and decision will be taken for actions Use Error report Template 1551 for error registrations Document ID Version Page 43 65 Acceptance test Plan Report for F26 1
33. er of users 4 10 Other N A Document ID Version Page 34 65 System test Plan Report for 1 F26 Temperature According to ITS 90 Template 1544 Utgava 5 0 Referens SOP 1540 GAMBRO Renal Products 5 Errors during the test The errors that occurred during the tests are described in the table below Actions that need to be taken will be described in the Error report If changes in the software will be necessary the software or parts of the software need to be retested Test description Expected results Actual Error Result Report ID Errors Document ID Version Page 35 65 System test Plan Report for 1 F26 Temperature According to ITS 90 Template 1544 Utgava 5 0 Referens SOP 1540 GAMBRO Renal Products Appendix 6 System test Error Reports Error report for Error ID 1 System F26 Temperature According to ITS 90 Prepared by Name Project function Date Signature Carl Tillman Validation Manager Reviewed by Name Project function Date Signature Project Manager Approved by Name Project function Date Signature Lars G ran Development Andersson manager Document ID Version Page 36 65 Error report 1 for F26 Temperature According to ITS 90 Template 1551 Utg va 2 0 Referens POP 1771 GAMBRO Renal Products Revision History Version Date Revised by Comments 1 Carl Tillman First i
34. eseecssecaeeaaees 15 3 3 2 Emanuel 15 3 3 3 Design Constraints sut scasseassectiassSeceveca ters toes seen a A dakt dateantydeanadel saa ees vaca aa ae feats 15 3 4 DOCUEILY vscciscsccesstecsesccesscessecsccesctessisecesdesscacnscacstencsdccseecsdacoiscesdcetucsscessecsseatdasscacseeaessesteassuescades 15 3 5 AV ALIS sisi cvessesacsssseessossscsseesseesssoosscsoesnseedsovssesdesecnncesevsseseonbenecesetsscevesecncassseesecoosnesoeseressscsesneses 16 3 6 EQLOLS EE SN 16 3 7 Other Requirements ennnenneenvernnvennrennvennnennnennnennnennnesnnennnnsnnneunneennennnennnennnnennnennneneneneneneneeene 16 4 Docuimentationuuisisandskksasssknastlskaeadssd eda 16 4 1 User Mamba Sisis csissssnssssssveccesssescssssevossssssoscsscesvenscadsoseases sseoscsssebesecssscescasseesseesseeessdessesessesoeeses 16 1 Introduction This document is divided into two primary sections the Overview section and the User and Functional Requirements section The Overview section describes the Product Perspective General Constraints and Assumptions and Dependencies The User and Functional Requirements section describes the User Requirements and the Functional Requirements for the system It also describes External Interface Requirements Performance Requirements Design Constraints Attributes and Other Requirements The references and definitions are described in SOP 1540 Document ID Version Page 11 65 Software Requirement Specification for 1 F26 Temperature According t
35. following functionality 1 Manage data for user profiles 2 Manage data for Pt 25 thermometers 3 Calculate temperatures according to ITS 90 The software shall be able to calculate temperatures correctly in the range 40 C to 290 C 3 3 Performance Constraints 3 3 1 Performance Requirements The software shall have the capacity to manage simultaneously Calibration data for up to 3 Pt 25 thermometers User data for up to 5 user accounts The software shall be able to calculate Temperatures with a repetition rate of 1 Hz or higher 3 3 2 Limitations N A 3 3 3 Design Constraints The software shall be developed with LabVIEW 6 1 3 4 Security The software shall be password protected Users shall be able to log in at 3 different user levels with access rights at each level according to Operator level Access to Pt 25 data Access to User profiles Operator Read No access Technician Read Write No access Administrator Read Write Read Write Document ID Version Page 15 65 Software Requirement Specification for 1 F26 Temperature According to ITS 90 Template 1554 Utgava 2 0 Referens SOP 1540 OG AMBRO Renal Products User ID and passwords must not be stored in a format directly readable for humans e g unencrypted text files 3 5 Alarms N A The system is not designed to include any Alarm functions 3 6 Errors The software shall communicate errors and warning messages to the
36. ify that temperature is Temperature is displayed displayed with large fonts in a large font and is Font size cannot easily be easy to read determined from screen ia ee a es l S o oo shown on screen displayed m ea ee TT displayed on the screen displayed El l T T ooo displayed displayed 4 3 6 Verify that Tip strips can be Tip strips shown when objects on the screen Document ID Version Page 45 65 Acceptance test Plan Report for 1 F26 Temperature Template 1547 Utgava 3 0 Referens SOP 1540 GAMBRO R nal Products 4 4 Functions Purpose and descriptions The purpose of this test case is to verify that all specified functionality is contained in the software Pass or Report ID a manage user data managed manage Pt 25 probe data managed Verify that the software can correctly calculate a temperature lt 0 01 C Verify the calculation according to ITS 90 Note all values from screen below Probe ID Read resistance Read temperature C Verify that the software can correctly calculate a temperature gt 0 01 C Verify the calculation according to ITS 90 Note all values from screen below Probe ID DocumentID Version Page 466 ID F26 Temperature Template 1547 Version Acceptance test Plan Report for 1 Utgava 3 0 Manual calculation confirms that the displayed temperature is correctly shown with at least two decimals Manually calculated temperature Manu
37. ion Date Revised by Comments Table of contents 1 Qe ee er 18 2 Architecture Interface sciiisssscssssscscssssssssvnsscssssnsscsseacscasssscscssscasscscsssssescasasccecsoasccecssseccacmeasececnsas 18 3 UM COONS AIEA E EE E E E E og secseuuseucccessseassdeacectens esel 19 4 Data Architecture Data StructUre esssessseeeesscececccececseceeecceccececceecceecececcseceseccccceseseseeesesesesesee 21 5 SOCUTTEY EE PN 21 6 AAPG PAE PP E BAPE EE EAA E AEE E AT A A E E 21 7 Error Handling wiicssscctcssecsastocssccvessessestoussceuessesvavvscussstessssnosbssveseseesseustile sonst secsscsuseusasedecnscsvnnsseenses 21 8 Installation instructions eeseeseeeseeeseessesssesssesssesssessseseeesseeeseesseeeceeeseeeseesseeeseseseeeseseseseseeesesesesesee 22 1 Introduction The software displays momentary values of temperature measured with a platinum resistance thermometer attached to a resistance bridge This system forms the primary temperature standard at Gambro Lundia AB The software is developed and used by personnel from the Calibration Group 2 Architecture Interface The software is based on a program flow as illustrated in the figures below select probe amp change password configure users configure probes Initialisation select probe amp read data configure probes Interface Document ID Version Page 18 65 Software Design Specification for 1 F26 Temperature According to ITS 90 Template 1
38. mmended to update the software at the next release so that a check is made that the probe ID is unique and must not be left blank Document ID Version Page 39 65 Error report 2 for 1 F26 Temperature According to ITS 90 Template 1551 Utg va 2 0 Referens POP 1771 GAMBRO Renal Products Error report for Error ID 3 System F26 Temperature According to ITS 90 Prepared by Name Project function Date Signature Carl Tillman Validation Manager Reviewed by Name Project function Date Signature Project Manager Approved by Name Project function Date Signature Lars Goran Development Andersson manager Document ID Version Page 40 65 Error report 3 for F26 Temperature According to ITS 90 Template 1551 Utgava 2 0 Referens POP 1771 GAMBRO Renal Products Revision History Version Date Revised by Comments 1 Carl Tillman First issue Version Date Revised by Comments Version Date Revised by Comments 1 Description 1 1 Test Test case 4 3 28 Log in as Administrator Click button Users and then click Create 1 2 Expected result It is possible to create a new user account Undefined whether it should be possible to create more than one user with the same user name and whether user name can be left blank 1 3 Actual result It is possible to create a new user account It is possible t
39. nesnnnsennennneenneennennneennnsnnennnnsnnnennnennsee 62 3 Design and or Purchase sssccsssscscssccssasscscsssesssocovssccssassnnsseosessssessossseoassseseesssovssasescssessssvasascbssdecuess 62 3 1 Software Design Specification eeeeevvervvennvennvennrernneennesnnnvennennnesnnennnennnennnenennsnnnennnennnennnennneen 62 3 2 Supplier Qualification recevesevoeenneenneennesnnennnvennrennnennnennnennnnsnnnennnennnennnennnennnnennnennnennneenneenne 62 4 Implementation eooseoevornvovevnennennnesnneennvennnennnennnennnennnnnnnenenenennennnennnnnnnennnnnnnnnnnnennnenennnnnnnennevnnennsee 62 4 1 System documentation seeevernvernneeenneenneennesnnennnrennnennnennnenenennnnsnnnennnennnennnennnennnnennnennnennneenneenee 62 4 2 System test report essresnvennvennvennneennneenneennennnennnennnnennnennnennnnsnnennnennnennnnnnnnennnennnennnnnnnnnnnennnnnenee 62 TE TeSt a E A E E E E E 62 5 1 Acceptance test report ressnrssnrennrennarnnnennnennnennnennnennnnnnnnennnennnennnennnesnnesennsennnenneennesnneneneneneene 62 6 Preparation for Maintenance reseresvesvesnnannnnennnennnennnennnennnnnnnennnnennnennnennnnnnnesnnesnnenennennneenneenneeee 62 6 1 User Manual esesevesveeennennnennneennesnneennrennnennnennnennnennnennnnennnnnnnennnennnennnnnnnnnnnnennnnnenenennnennennnennsee 62 6 2 Installation Training documentation eoesvesnnvennvennvennnennnennnennnesnnesnnennnennneenenennnennnennneenne 62 7 Change control esnnesnvvrnvrnenrrnnrrnnnen
40. ng Validation Team meetings Contributing to creating and reviewing approving computer validation documentation Ensuring compliance with the Validation Plan throughout the validation process Communicating go no go recommendations 3 Validation Approach 3 1 Assumptions It is assumed that the ASL F26 and the Pt 25 comply with their technical specifications It is assumed that the latest Pt 25 calibration report from SP is technically correct 3 2 Scope The purpose of the validation effort is to ensure that the software is validated in accordance with SOP 1540 3 3 Dependencies The validation is dependent on that the hardware is functioning as some tests can only be made on the system as a whole 4 Test 4 1 System Test Plan Report The system test will be conducted against the Software Design Specification for F26 Temperature According To ITS 90 The results of system testing will be documented in the System test Plan Report for F26 Temperature According To ITS 90 4 2 Acceptance Test Plan Report The system test will be conducted against the Software Requirements Specification for F26 Temperature According To ITS 90 Document ID Version Page 7 65 Validation plan for 1 F26 Temperature According to ITS 90 Template 1546 Utgava 2 0 Referens SOP 1540 GAMBRO Renal Products The results of acceptance testing will be documented in the Acceptance test Plan Report for F26 Temperature According To ITS
41. nnennnennnennnnennnennnennnennnennnenenenennennneennenen 9 System Maintenance eessesssvenevennnennnennnannnnnnnnennnennnennnennnennnennenennnennnennnennnennnennnennnenennsenennnennnnennnenen 10 Document Maintenance eesosesssvennvennvennnnnnnnnnnnnnnnnnnnnnnnennnennnennnnnnnnennnennneennennnennnennnennnennnesnnnennneenee 1 Introduction The software F26 Temperature According to ITS 90 version 1 0 displays values of temperatures measured with a platinum resistance thermometer attached to a resistance bridge This system forms the primary temperature standard at Gambro Lundia AB The software is developed custom made and used by personnel from the Calibration Group Therefore no Supplier Qualification will be made 2 Roles and responsibilities 2 1 Validation Team Role Name SC Abbreviation System Owner Evert Hakansson Quality Assurance Christer Magnusson Validation Manager Carl Tillman Document ID Version Page 6 65 Validation plan for 1 F26 Temperature According to ITS 90 Template 1546 Utgava 2 0 Referens SOP 1540 GAMBRO Renal Products Validation Team Lars G ran Andersson Kenneth Bengtsson Development Manager Lars G ran Andersson Development Team N A KG 2 2 Responsibilities of the Validation Group members The individual roles responsibilities are defined in SOP 1540 Validation of administrative and technical software The Validation Team members are also responsible for the following Attendi
42. nnnennnesnnesnnennnnennnennnennnennnnsnnenenenenneensee 35 1 Introduction This document is used for the system test of the F26 Temperature and will include both test plan and test results The requirements from the Software Design Specification have been converted to test cases and test criteria The references and definitions are described in SOP 1540 2 Test environment The tests were conducted on a PC meeting the requirements stated in the SRS for F26 Temperature According To ITS 90 section User and Function Requirements 3 Test results When the tests are finished the errors will be reviewed and decision will be taken for actions Use Error report Template 1551 for error registrations Document ID Version Page 24 65 System test Plan Report for 1 F26 Temperature According to ITS 90 Template 1544 Utg va 5 0 Referens SOP 1540 GAMBGRO Renal Products 4 Tests 4 1 Installation Purpose and descriptions The purpose of this test case is to verify that the software can be installed according to the Installation Manual Test description Expected results Result Error Pass or Report ID 4 1 1 Installation of the software on Installation successful PC running Windows 95 and it is possible to start the program 4 2 Architecture Interface Purpose and descriptions The purpose of this test case is to verify that the software meets the requirements for input output Test description Expected results Result Error
43. nnnnnnnnennnenenenennnennennnennnennsee 53 2 1 Graphic Overview eresernnernnernrernnrsnnrennrennnennnennnnsnnennnenennnnnnnennennnennnennnnnnnnenenenennnenennnnnennennnennsee 53 3 FUN COONS aisseasssss cosstssessdseesscosssesessscesessessscsedseuedessessvesssecdesecsesssebesesVesecsedesubesbedesecsesseueesbescssddedeevens 53 4 Data Architecture Data Structure sccccccssssssssssssscssscssssssssecccsssssssscscessccssssssssessssssssossees 57 5 Client Server EE sosis v sssusa usau sausso soussi 58 6 NETT EN EG NE Se 58 7 GE OE NN 58 8 Error handling esesovernvernvernvesnnneenneenneennennnesnnennnnennnennnennnenenennnnsnnnennnennnennnennnennnennnennnnenenennnennneenee 58 9 Mr StallAtOM siciccsiss cscssescscssessscesesesessavesescedesesnssecsssestss A EE A 58 10 Third party components eevevernvervenverenennnennnnennnennnennnennnnnnnnnnnnnnnnennnennnennesnnesnnennnnenenennnennnnnnnnenen 59 1 Introduction The software F26 Temperature According to ITS 90 version 1 0 displays values of temperatures measured with a platinum resistance thermometer attached to a resistance bridge This system forms the primary temperature standard at Gambro Lundia AB The software is developed custom made and used by personnel from the Calibration Group Therefore no Supplier Qualification will be made Definitions and acronyms The following definitions and acronyms are used in the validation documents for this software F26 A resistance meas
44. o ITS 90 Template 1554 Utgava 2 0 Referens SOP 1540 GAMBRO Renal Products 2 Overview 2 1 System Perspective The software F26 Temperature According to ITS 90 version 1 0 displays momentary values of temperature measured with a platinum resistance thermometer attached to a resistance bridge This system forms the primary temperature standard at Gambro Lundia AB The software is developed and used by personnel from the Calibration Group Definitions and acronyms The following definitions and acronyms are used in the validation documents for this software F26 A resistance measuring bridge manufactured by Automatic Systems Laboratories ASL The F26 is equipped with a GPIB interface GPIB General Purpose Interface Bus The standard bus used for controlling electronic instruments with a computer Also called IEEE 488 bus defined by ANSI IEEE Standards 488 1978 488 1 1987 and 488 2 1992 ITS 90 The International Temperature Scale of 1990 Defines procedures by which certain specified practical thermometers can be calibrated in such a way that the values of temperature obtained by them can be precise and reproducible Platinum resistance thermometers are specified for use from 13 8033 K up to 962 78 C LabVIEW Laboratory Virtual Instrument Engineering Workbench A graphical programming language using icons instead of lines of text as source code Pt 25 A platinum resistance thermometer of the highest qualit
45. o create multiple users with the same user name and a user with no user name Resulting anomalies errors 5 If more than one user is created some of the users that have the same name will not be able to login 6 Ano name user will not not leave any name in the main window 2 Extent This is not a critical error and the outcome was never clearly specified 3 Decision No need of re test It is recommended to update the software at the next release so that user name must be unique and must not be left blank Document ID Version Page 41 65 Error report 3 for 1 F26 Temperature According to ITS 90 Template 1551 Utgava 2 0 Referens POP 1771 GAMBRO Renal Products Appendix 7 Acceptance test Plan Report Acceptance test Plan Report Prepared by for F26 Temperature According to ITS 90 Name Project function Date Signature Carl Tillman Validation Manager Plan reviewed by Name Project function Date Signature Project Manager Report reviewed by Name Project function Date Signature Project Manager Plan approved by Name Project function Date Signature Evert H kansson System owner Report approved by Name Project function Date Signature Evert H kansson System owner Document ID Version Page 42 65 Acceptance test Plan Report for F26 Temperature According to ITS 90 Template 1547 Utg va 3 0 Referens SOP
46. o temperatures Pt 25 resistance values are read via GPIB from a F26 The ITS 90 temperature corresponding to the resistance is calculated and displayed on screen The formula for calculating temperatures is depending on two coefficients a and b These coefficients have different values for temperatures lt 0 01 C and gt 0 01 C respectively The software can calculate temperatures correctly in the range 40 C to 290 C limited by ITS 90 conversion formulas The main functionality of the software is 7 Login Manage data for user profiles 8 Manage data for Pt 25 thermometers 9 Calculate temperatures according to ITS 90 Document ID Version Page 53 65 System documentation for 1 F26 Temperature According to ITS 90 Template 1543 Utgava 2 0 Referens SOP 1540 GAMBRO Renal Products gt Login Login Manage data for user profiles Atlog in the user shall be prompted to enter user name and password in a dialog box seran MG If not correct name and password are ok Cancel entered the software shall display an appropriate message and display the login dialog box once again When a user has logged in with Administrator access right he she shall be able to active Manage data for user profiles by clicking a button labelled Users gt Configure Users Kenneth Bengtsson a Lars G ran Andersson Lars G ran Andersson When a user has logged in with Operator or Technician access right the butt
47. on Users shall be deactivated so as he she shall be able to active Administrator shall be able to create new user accounts Administrator shall be able to delete users registered in the user list Administrator shall be able to update data for any user This includes all fields name in full user name password and level It shall not be possible all to erase all users at administrator level or change the level of the last Administrator to another level At least one administrator must be left operator 0 Document ID Version Page 54 65 System documentation for 1 F26 Temperature According to ITS 90 Template 1543 Utg va 2 0 Referens SOP 1540 GAMBRO Renal Products All users shall be able to change password by clicking the button Password 6 Change Password When changing password the user shall be prompted to enter a new password twice in a dialog box If the two passwords being entered are not identical or if the password is less than 4 characters in length the software shall display an appropriate message and display the change password dialog box once again Manage data for Pt 25 thermometers All users shall be able to activate select probe by clicking the button Probe in the main window Allusers shall be able to select a probe from the list of registered probes in the Select or Edit Pt 25 Probe Data window When a probe i
48. on Date Revised by Comments Version Date Revised by Comments 1 Categorizing the software Category 1 _ 1p Category 2 _ 3p Category 3 X 5p Comments Software is developed by Gambro Lundia AB 2 Interaction with other Software 2 1 Input from other software None _ 1p Some X 2p Large _ 3p 22 Output to other software None X 1p Some 2p Large _ 3p Comments nput from operator and from the measuring device Output to operator only 3 Impact 3 1 Product quality Medium Low probability probability High impact Dep Rap Medium impact Comments It is considered to be low probability for the software to calculate temperatures wrongly although the impact is high since instrument will then not be correctly calibrated Low probability probabilit probabilit B l Mp Dep lp lp High probability Ge ep 3 2 Regulatory impact High impact Medium impact Document ID Version Page 3 65 1 Risk Analysis for F26 Temperature According to ITS 90 Template 1552 Utg va 3 0 Referens POP 1772 GAMBRO Renal Products Comments This is a technical system with limited regulatory impact 4 Possibility to detect error High 1 1p Medium X 2p Low 1 3p Comments The software contains some error handling although it cannot determine whether correct temperatures are displayed 5 Total risk Use the formul
49. s selected the corresponding data for that probe shall be displayed gt Select or Edit Pt 25 Probe Data o folo eoe 0 0000000E 0 l 0 0000000E 0 0 0000000E 0 0 0000000E 0 Document ID Version Page 55 65 System documentation for 1 F26 Temperature According to ITS 90 GAMBRO Renal Products Ifa probe is selected the software shall ERAL display a warning if the calibration date s expired see section 7 below Ifa probe is selected and any other gt Warning probe is registered with a later calibration data the software shall display a warning see section 7 below Administrators and technicians shall be able to edit data for any probe This includes the following data The calibration date for the latest calibration certificate Calibration certificate number The resistance at the triple point of water R0 01 The coefficients a and b for temperatures gt 0 01 C The coefficients a and b for temperatures lt 0 01 C Administrators and technicians shall be able to create records for new probes by clicking the button Create After a new record is created empty data fields shall be displayed and the user shall be able to edit data as above Administrators and technicians shall be able to delete registered probes by clicking the button Erase Administrators and technicians shall be able to reset changes by clicking the button ID number calibration date 2000 1
50. ssue Version Date Revised by Comments Version Date Revised by Comments 1 Description 1 1 Test Test case 4 3 5 and 4 3 6 Log in as Administrator Try to erase all but one Administrator 1 2 Expected result All but one Administrator can be erased Undefined whether it should be possible to erase the user account that is presently logged on 1 3 Actual result All but one Administrator can be erased It is possible to delete the user account which is logged in when logged in as an Administrator Resulting anomalies errors 1 When clicking OK the main Windows is displayed again Despite having erased the user account used for login the same account is still shown as being the current user 2 If now clicking Password the software tries to read information about the user account that has just been erased This causes the software to display an error dialog 2 Extent This is not a critical error and the outcome was never clearly specified 3 Decision No need of re test It is recommended to update the software at the next release so that the currently logged in user account cannot be erased Document ID Version Page 37 65 Error report 1 for 1 F26 Temperature According to ITS 90 Template 1551 Utgava 2 0 Referens POP 1771 GAMBRO Renal Products Error report for Error ID 2 System F26 Temperature According to ITS 90 Prepared by
51. tor can press the Log in button in normal mode Run the software in normal Manual calculation operation Note all data for the confirms that the selected probe and try to displayed temperature is freeze a value for both the correctly shown with at resistance and the least two decimals temperature shown in the main window Verify the calculation according ITS 90 Manually calculated Probe ID temperature Read resistance Q C Read temperature _ button Users and then click new user account Create Document ID Version Page 31 65 System test Plan Report for 1 F26 Temperature According to ITS 90 Template 1544 Utgava 5 0 Referens SOP 1540 GAMBRO R nal Products 4 4 Data Architecture Data Structure Purpose and descriptions The purpose of this test case is to verify that user data is encrypted Test description Expected results Result Error Pass or Report ID Verify that at least three users Neither user names nor are registered Close down passwords can be read the software open the ini file in directly in an editor an editor Verify that no user names nor passwords can be read without data manipulation 4 5 Security All tests of security functionality is integrated in the functions test See section 4 3 above 4 6 Alarm N A Document ID Version Page 32 65 System test Plan Report for 1 F26 Temperature According to ITS 90 Template 1544 Utgava 5 0 Referens SOP 15
52. ull Document ID Software Design Document for 1 F26 Temperature According to ITS 90 Version Indicator 4 probe Data Type cluster of 8 elements Description Probe data Indicator 4 1 name Data Type string Description Gambro ID number Indicator 4 2 calibration date Data Type cluster of 3 elements Description Latest calibration date Indicator 4 2 1 year Data Type unsigned long 32 bit integer 0 to 4 294 967 295 Description Year Range 2000 2040 Indicator 4 2 2 month Data Type unsigned long 32 bit integer 0 to 4 294 967 295 Description Month Range 1 12 Indicator 4 2 3 day Data Type unsigned long 32 bit integer 0 to 4 294 967 295 Description Day Range 1 31 Indicator 4 3 certificat Data Type string Description Calibration certificate number Indicator 4 4 R0 01 ohm Data Type double 64 bit real 15 digit precision Description Probe resistance at 0 01 C Indicator 4 5 a t gt 0 01 C Data Type double 64 bit real 15 digit precision Description ITS 90 coefficient for t gt 0 01 C Indicator 4 6 b t gt 0 01 C Data Type double 64 bit real 15 digit precision Description ITS 90 coefficient for t gt 0 01 C Page 65 65
53. urce code in LabView The text is stored in its raw text format and has not been formatted or styled The program modules developed in LabView are called Vis Identification of the different modules can be done by searching for stext strings ending with vi 2 Design Documentation F26 Temperature According To ITS 90 vi VI Path I Records Confidential Mjukvara F26 Temperature According To ITS 90 F26 ITS 90 version 1 0 F26 Temperature According To ITS 90 IIb F26 Temperature According To ITS 90 vi Last Modified 2002 09 02 16 18 Version 121 VI Description Code by Lars G ran Andersson Calibration Group Gambro Lundia AB Controls and Indicators Control 1 password Data Type boolean TRUE or FALSE Description Change password for the current user Control 2 log in Data Type boolean TRUE or FALSE Description Log in as new user Control 3 users Data Type boolean TRUE or FALSE Description Edit user information Control 4 new probe Data Type boolean TRUE or FALSE Description Select or edit probe Control 5 stop Data Type boolean TRUE or FALSE Description Indicator 1 temperature Data Type double 64 bit real 15 digit precision Description Temperature C Indicator 2 resistance Data Type double 64 bit real 15 digit precision Description Resistance ohm Indicator 3 user Data Type string Description User s name in f
54. uring bridge manufactured by Automatic Systems Laboratories ASL The F26 is equipped with a GPIB interface GPIB General Purpose Interface Bus The standard bus used for controlling electronic instruments with a computer Also called IEEE 488 bus defined by ANSI IEEE Standards 488 1978 488 1 1987 and 488 2 1992 ITS 90 The International Temperature Scale of 1990 Document ID Version Page 52 65 System documentation for 1 F26 Temperature According to ITS 90 Template 1543 Utgava 2 0 Referens SOP 1540 GAMBRO Renal Products Defines procedures by which certain specified practical thermometers can be calibrated in such a way that the values of temperature obtained by them can be precise and reproducible Platinum resistance thermometers are specified for use from 13 8033 K up to 962 78 C LabVIEW Laboratory Virtual Instrument Engineering Workbench A graphical programming language using icons instead of lines of text as source code Pt 25 A platinum resistance thermometer of the highest quality A Pt 25 has a nominal resistance of 25 ohm at 0 C 2 System Architecture The software is based on a program flow as illustrated in the figures below 2 1 Graphic Overview select probe amp change password configure users configure probes Initialisation select probe amp read data configure probes 3 Functions The purpose of the software is to automate the conversion of measured resistance values int
55. user Situations that shall trigger such messages are Errors Error in the communication with the F26 Read write error for configuration data Warnings Calibration date for chosen Pt 25 has expired Calibration date not the latest there is another Pt 25 with a newer calibration date 3 7 Other Requirements N A 4 Documentation 4 1 User Manuals No separate User Manual is produced User Instructions are included in the System Documentation for F26 Temperature According to ITS 90 Document ID Version Page 16 65 Software Requirement Specification for 1 F26 Temperature According to ITS 90 Template 1554 Utgava 2 0 Referens SOP 1540 GAMBRO Renal Products Appendix 4 Software Design Specification Software Design Specification Prepared by for F26 Temperature According to ITS 90 Name Project function Date Signature Carl Tillman Validation Manager Reviewed by Name Project function Date Signature Project Manager Approved by Name Project function Date Signature Lars G ran Development Andersson Manager Document ID Version Page 17 65 Software Design Specification for F26 Temperature According to ITS 90 Template 1553 Utg va 2 0 Referens SOP 1540 OG AMBRO Renal Products Revision History Version Date Revised by Comments 1 Carl Tillman First issue Version Date Revised by Comments Vers
56. x If not correct name and password are entered the software shall display an appropriate message and display the login dialog box once again When a user has logged in with Administrator access right he she shall be able to active Manage data for user profiles by clicking a button labelled Users When a user has logged in with Operator or Technician access right the button Users shall be deactivated so as he she shall be able to active Administrator shall be able to create new user accounts Administrator shall be able to delete users registered in the user list Administrator shall be able to update data for any user This includes all fields name in full user name password and level It shall not be possible all to erase all users at administrator level or change the level of the last Administrator to another level At least one administrator must be left Document ID Version Page 19 65 Software Design Specification for 1 F26 Temperature According to ITS 90 Template 1553 Utgava 2 0 Referens SOP 1540 OG AMBRO Renal Products All users shall be able to change password by clicking the button Password When changing password the user shall be prompted to enter a new password twice in a dialog box If the two passwords being entered are not identical or if the password is less than 4 characters in length the software shall display an appropriate message and
57. x 4 Software Design Spebheahonuuumrskmmenneenernineve ivei 17 Appendix 5 System test Plan Re 0 REE 23 Appendix 6 System Lest Error Re Parts sccssccsssisccsnscssissnesssenssinasennnecesasoncassecsnsnserannanion 36 Appendix 7 Acceptance test Plan Beoport wcccssisccsensscccsssiacccsssnecssescssessenssscessnacsresensoassnne 42 Appendix 8 System Docomenta OD sumnnseenesmnenneianmiekvdvinkindieskauitenkbedannbekndken ke 51 Appendix 9 Validation Keporiumssmseemneeeneneineesniiieten je tie 60 Appendix 10 Software Design Document eserevsvenveenevennnerennvnnnennnnnnnnenennnennennesnnnennnnenesee 64 1 edition November 2002 Gambro Nordtest F26 ITS90 1 0 Appendix doc GAMBRO Renal Products Appendix 1 Prepared by Risk analysis Risk analysis for F26 Temperature According to ITS 90 Name Project function Date Signature Carl Tillman Validation Manager Reviewed by Name Project function Date Signature Project Manager Approved by Name Project function Date Signature Evert Hakansson System Owner Name Project function Date Signature Christer Magnusson Quality Assurance Document ID Version Page 2 65 Risk Analysis for F26 Temperature According to ITS 90 Template 1552 Utgava 3 0 Referens POP 1772 GAMBRO Renal Products Revision History Version Date Revised by Comments 1 Carl Tillman First issue Versi
58. y A Pt 25 has a nominal resistance of 25 ohm at 0 C Document ID Version Page 12 65 Software Requirement Specification for 1 F26 Temperature According to ITS 90 Template 1554 Utgava 2 0 Referens SOP 1540 OG AMBRO Renal Products 2 1 1 General architecture Pt 25 resistance values are read via GPIB from a F26 The ITS 90 temperature corresponding to the resistance is calculated and displayed on screen PC Pt 25 X XXX F26 The formula for calculating temperatures is depending on two coefficients a and b These coefficients have different values for temperatures lt 0 01 C and gt 0 01 C respectively 2 1 2 General Constraints If ITS 90 is replaced or updated the software must be examined for agreement with the new standard Any discrepancy has to be resolved by update of the software 2 2 Assumptions and Dependencies It is assumed that the users are familiar with the Windows operating system It is assumed that the GPIB hardware and software is properly functioning It is assumed that all original user data and probe data is recorded on paper and hence there is no need for backup of any electronic information handled by the software It is assumed that for the acceptance test of correct calculation of temperatures it is sufficient with two test points one for a temperatures lt 0 01 C and the other for a temperature gt 0 01 C
59. y clicking the button Reset This will reset any changes made before confirmation by clicking OK Pressing the OK button will save all changes and the software proceeds to the main screen It is then not possible to Reset any changes When a user is logged in as Operator both buttons Create or Erase shall be deactivated and thus not allow new records to be created or old ones to be erased Calculate temperatures according to ITS 90 When no other windows are displayed other than the main window the software shall continuously read calculate temperatures and display temperatures This is the default mode of the software For repetition rate see section 3 3 1 in the SRS When the software is executing in default mode as defined above any users with a high enough access right shall be able to activate the other functions as described above Document ID Version Page 20 65 Software Design Specification for 1 F26 Temperature According to ITS 90 Template 1553 Utgava 2 0 Referens SOP 1540 GAMBRO Renal Products The software shall calculate temperatures according to the ITS 90 This shall be done by reading resistance values from the F26 and converting them to ITS 90 temperatures by using the inverse reference functions 9b and 10b as well as the deviation functions 12 and 13 defined in ITS 90 4 Data Architecture Data Structure All registered data used by the software shall be stored as an ini file
60. ys the warning that is not the latest among message Another probe the registered probes has a later calibration Requires at least probes being date registered 4 3 16 Log in as Administrator and as OK as Administrator or Technician Click Probe Technician to edit any select a probe and edit data data for a probe for that probe 4 3 17 Log in as Administrator and as OK to create new probe Technician Click Probe and data as Administrator or then click Create Technician All data fields shall be clear apart from ID number 4 3 18 When anew record has been OK to edit data for new created try to edit data probe as Administrator or directly Technician 4 3 19 Log in as Administrator and as OK to erase probe data Technician Click Probe as Administrator and select a probe and click Technician Erase Document ID Version Page 29 65 System test Plan Report for 1 F26 Temperature According to ITS 90 Template 1544 Utgava 5 0 Referens SOP 1540 GAMBRO Renal Products Test description Expected results Result Error Pass or Report ID Log in as Administrator and as OK to Reset changes Technician Click Probe and made before any edit create or erase any confirmation OK record Click button Reset button before confirming by clicking OK 4 3 21 Log in as Administrator and as The software stores Technician Click Probe and

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