Software 21CFR Part 11 testo ComSoft CFR 3.4 Instruction manual
Contents
1. Samplet fl office this is my comment S F testostorl71 I office Reason for logging Bus connect 4 ed settin 20 01 2003 07 52 07 72 8 23 4 20 01 2003 07 52 10 57 0_ 23 3 0 20 01 2003 07 52 13 49 2 23 2 fice office Date Time rH PC te amp test 1 20 01 2003 07 51 20 8 2 20 01 2003 07 21 2 a 20 01 2003 07 22 6 4 20 01 2003 07 24 0 5 20 01 2003 07 25 0 6 20 01 2003 07 25 8 7 20 01 2003 07 23 5 is 9 1 In the header you will find the information texts entered before programming automatically shown is an indication that these are original data together with a 3 digit production number code and the 8 digit serial number and user identity information The name given to the record also appears at top left of the table the physical units are accompanied by the additional channel identifier allocated Note The expression original data designates measurement data collected and stored by the logger The dewpoint calculation in the testostor 171 can be activated separately in this case the data are considered to have been processed In the toolbar you can switch to a graphical representation you will then see a chart of measured data against time z TEN Eje bevumet Edt Wew Iset Format Took Window x SUSQ Ea E OOX a Ofcrran Wl Ri aeor tes sms A instru 171 2 ISerial 1508 1897 0049 aj Sommon2. 26 Local Security Settings Local Policies Security Options these are general system related settings action wew e om x Be G Audt Policy G9 User Rights Assignment E Publi Key Paice amp IP Security Policies on Local Machine Poly Loca seng Effecnve Settng a o u Administrators Administrators Amount o 15 minutes 15 minutes BQ audit the n Disabled Disabled 82 Audit use Disabled Disabled BQ Automaticah Enabled Enabled 2 Clar virtual memory pagef Disabled Disabled Digitaly sign dient commu Disabled Disabled Ei Digitaly sign dient commu Enabled Enabled Sx Duaitally sign server comm Disabled Disabled ES Digitally sign server comm Disabled Disabled B2 Dsable CTRL ALT DE re Not defined Not defined Bo not display last user na Disabled Disabled BRILAN Manager Authenticatio Send LM amp NTL SendM amp NIL 10 logons 10 logons Disabled Disabled BiPrevent user Disabled Disabled BgPrompt us a 14days 14 days Disabled Disabled Disabled Disabled EgRename administrator acc Not defined Not defined B2 Rename quest account Not defined Not defined gt Disabled Disabled Disabled Disabled Disabled Disabled Enabled Enabled Enabled Enabled Disabled Disabled Disabled Disabled Si Shut down system immed Disabled Disabled amp 2 Smart card removal behavior No Action No Acton 2 Strengthen default permissi Enabled Enabled Unsigned driver instalation
3. H POAbendheld ample fles 2 7 Bus conne Setting up Start the Comfort Software and click on Instrument New Instrument from the list select testostor 171 Once various guided entries have been made the device driver symbol appears at the left of the window in the archive area Double click on the instrument to open it right click on the instrument symbol and select Instrument Control in the shortcut menu Programming You will be presented with the main data logger control window x Loggertype 171 2 Serial number 508 1897 0049 Close Main info Firmware T171 2 61 Load program Save program Probe name Probe configuration emperetur Set up program Options Program logger Start In the Main info area you can enter a text that for example describes the immediate circumstances of the measurement this window can also include information for the person responsible for the instrument or its identification Under Probe configuration the upper and lower limits of each channel can be defined in addition a name can be allocated for each measurement channel Important After programming this information will be saved in the logger EEPROM and when the data are being evaluated is available as automatically transferred data 33 Data logging with testostor 171 as an example 34 Note Operate the data logger within a closed system Rotating operation with a number of PCs o
4. It is also the responsibility of the user operating organisation to ensure that the measurement data are available during the required procedural period General information 21 CFR Part 11 and terminology used What is 21 CFR Part 11 Section 21 of the Code of Federal Regulations CFR is a part of the laws and regulations passed by the government of the United States of America in connection with the Food and Drug Administration FDA In particular Part 11 deals with Electronic Records and the use of Electronic Signatures i e with the handling of electronically stored data and the required security measures What is affected by these regulations All data that are included in GxP inspections and are permanently held on electronic data storage media Thus all files and data that may be included in an FDA inspection are affected Also affected are all electronic signatures that as computer generated authorisations represent the legally binding equivalent of handwritten signatures Why are these regulations so important In the pharmaceutical industry paper based systems are increasingly being replaced by electronic systems and procedures In order for these data records to be recognised by the FDA as authentic and legally binding in the same way as the former paper based organisations and processes the requirements of 21 CFR Part 11 must be fulfilled These regulations provide that data records in the pharm
5. Service menu and activate Display service data Username Mustermann Company Testo AG Windows version dawPlatformId 2 qwVersion 5 0 dwBuildNumber 0x00000893 szCSDVersion Service Pack 2 System Processor 586 Avaliable physical Memory 106604 KB Total physical Memory 253424 KB Example of software information Comsoft version C Programme Testo Comfort Software comsoft exe V 3 30 0 320 Flags 00000000 corepg tsuminfo V 3 30 0 0 Flags 00000000 teddka tceddk V 3 30 0 0 Flags 00000000 comscore V 3 30 0 0 Flags 00000000 devcore V 3 30 0 314 Flags 00000000 comsres V 3 30 0 0 Flags 00000000 teddke V 3 30 0 0 Flags 00000000 teuiext V 3 30 0 0 Flags 00000000 tcole V 3 30 0 0 Flags 00000000 tcfunc V 3 30 0 0 Flags 00000000 tecom V 3 30 0 0 Flags 00000000 57 0971 0436 02 T wh 27 03 2008
6. 19 11 2003 15 16 1000m sr File created 19 11 2003 15 16 1000m sr Lower limit 30 00 save as co K 1 rF humidity 19 11 2003 15 16 1000m sr Upper limit 80 00 save as co K 1 rF humidity E 19 11 2003 15 16 1000m sr Lower limit 15 00 save as co K 2 C temperature 19 11 2003 15 16 1000m sr Upper limit 25 00 save as co K 2 C temperature The following actions lead to an entry in this log Creating a document Saving a document after changes Signing or changing the signature of a document Lower limit value initialised Upper limit value initialised Lower limit value edited Upper limit value edited Title or comment changed Reset to original data Content changes Columns deleted or added New formula defined Row deleted Unit changed Channel name changed Column with converted unit added Note In some cases the text may be too long for the simple printing function Using the Export button an additional text format can be created which includes all the information Note Without the differentiation between system and file audit trails the requirement for availability of audit trails outside the system per document cannot be fulfilled Think also of the consequences of such a separation The document trail gives information related directly to the file where completeness is required or for system rela
7. 3 Professional In general no special knowledge is required to use the software the user interface look and feel is compatible with Microsoft Office and symbols and menu items are selected to comply with this standard If you already work with Office programs Word Excel PowerPoint you will very quickly find your way round this user interface 17 Access control at the system level 18 Users and User Groups New users being added and allocated to the individual user groups takes place at system level Click on Start select Settings and click on Control Panel Windows Update Programs Documents Network and Dial up Connections 2 Printers A Taskbar amp Start Menu Shut Down Excontroipen File Edit View Favorites Tools Help E Qsearch Folders History XA Ey Address Control Panel Sjadd Remove Hardware Bhaddr emove Programs SCAN Hardware I Date Time Fax f Folder Options Zt Game Controllers Internet Options SM Network and Dial up Connections Printers a Scheduled Tasks users and Pa Access control at the system level On double clicking on Users and Passwords you will find provided that you have administrator rights on this PC the list of all registered users of this PC and their membership of user groups Here you can give each individual user a new password and under properties check the properties of the s
8. Neither Testo nor the suppliers of Testo are liable to pay compensation for any losses arising as a result of use of this Testo product or the inability to use this Testo product even if Testo has been informed of the possibility of such a loss This exclusion does not apply for losses occasioned through intent or gross negligence on the part of Testo Claims founded on mandatory statutory provisions regarding product liability are likewise unaffected i Copyright by 2004 Testo AG Microsoft Windows and Excel are registered trade marks of Microsoft Corporation Contents COPYN ieissa veasien ce risssqeadacst acne naana aeaa 2 Introduction 3 Licence agreement Contents oo ee POPE USE se iscaccensscsaccttscsnutea int seeosnnesduan cesusstesndayscsaganeuaccineenacdineahadsacad General information about 21CFR Part 11 and the terminology used 8 Minimum system requireMent ccccccecccessseeeeeeeseessseeeeeesseeaaea 12 Information for theadministrator ssssisrririsoinenininiennieria 13 Carrying out the installation evi nininini 15 General information for the ComSoft CFR user ssec 15 Access control at the system leVel wo eceeeccseeesteeeeeseeetneeeetaee Individual users and user groups m ACGING A USEN irii css sitcadeteasdincs osdseasnannaandancenedeeasaindsenssncsnitenndeeen Individual parameters isnin E REN Ea Certificates electronic signatures ComSoft access Control
9. Not defined Not defined Y Unsigned non criver install Not defined Not defined For a detailed description see the User Manual for your Windows operating system Note By definition the control mechanisms of Windows Security seize on the system session A session carried out as part of an audit trail is ended correctly by a system lockout Log off as a user once the ComSoft application is finished Access control at the system level Certificates electronic signatures The ComSoft application allows data files to be inseparably combined with digital signatures Such signatures require a digital certificate These certificates establish a unique and secure relationship in the form of a handwritten signature to responsible persons In combination with file and system audit trails this enables changes to documents to be traceably recorded Such certificates must be availably locally on your computer they can be stored on the system under Control Panel Users and Passwords Advanced axl Users Advanced Certificate Management Use certificates to positively identify yourself certification authorities and publishers New Certificate Certificates P Advanced User Management Go Local Users and Groups can be used to perform advanced user management tasks Advanced Secure Boot Settings SH It is recommended that you require users to press P Ctri Alt Delete before logging on This ens
10. Note Changes in security settings only take effect after restarting the computer 30 e mail address for alarm and warning messages x y g oars Procedure aher tated logn Vex ngit Testn Comeo Admins F send ead to O Terto ComsotPowerUners el Teste Comet User Cascai If the sending of an e mail regarding error conditions has been activated an alarm or warning message is automatically sent to the address entered here as soon as an unauthorised user attempts to start the program irregularities in the user account file are found 31 Data logging with testostor 171 as an example Time zone Additional information on Time zone is available in the protocol heading beside Date Time It is an output box which cannot be overwritten The time zone information is available during ONLINE measurement day light savings time is taken into account 2570442003 2570422003 hbrmannna When reading out stored data from a data logger the space cannot be automatically filled The author of the document must decide which time zone is the basis The information can be stored directly under Time zone in the white space The time zone is set in Settings Control panel 32 Data logging with testostor 171 as an example Testo Comfort Software CFR Fle Instrument Edt View Insert Format Toot SHS Be 060 A BOR Filename 2 archive H Files
11. be and what should happen when it reaches this size Application Log Properties General Fiter Displey name Log name Crested Modified Accessed Log size Maximum log size 512 4 KB When maximum log size is reached C Overwrite events as needed G Overwrite events olderthan 7 C Donot overwrite events dear log manually E AWMINNTisystem32 contigAppEvent En Size 640 KB 65 536 bytes 26 July 2002 11 4214 03 September 2002 17 21 27 03 September 2002 17 21 27 fase Restore Defaults I Using a low speed connection Clear Log 2x Cad e i e how large it 51 File audit trail 52 File audit trail First open the file whose audit trail you wish to investigate and then click in the menu bar on File Display audit trail to view the list of file logs Testo Comfort Software CFR Fie Instrument Edit View Insert Format e Open E az Display audit trail 1 Offce You will then obtain a list of actions in date time order and assigned to the user who carried out the action To print out the audit trail file press the Print key Note ComSoft 3 facilitates the entry of long text at these points However please limit your text input to keywords as text which is too long will appear on your screen and will be saved with the file but will not be printed in full length File audit trail 19 11 2003 15 16 1000m sr File visa applied Als Verfasser
12. open ser measuring program x so a Co coca I Wrap around Meos rate 20 sec Name Ofice Date Time Dete Time Se fT Oo fo ea EE E fo for fe Duration Number of values hd 100 Into Number of measuring points 100 duration 0 days 00 03 18 Battery capacity 75 0 35 Data logging with testostor 171 as an example 36 Here you can enter parameters for the measurement start stop criteria cycle time and the duration of the measurement A text entry in Title will also be saved in the logger and helps to identify the file and data for later use If you now program the logger it is ready to record data in accordance with the new settings Saving settings Click on the logger symbol with the right mouse button and select Save settings from the shortcut menu the programming entries will then be saved under a name see folder Saved settings in the Archive Data area To program the same logger or type of logger in a number of different ways it is sufficient to copy the desired program to the logger by dragging and dropping the program symbol onto the logger symbol The title and comments can be modified Note Latest changes are updated immediately it is no longer necessary to buffer or reload the file a archive Ej C Sample files 3 testostor171 508 1897 0049 7 Bus connection Saved settings 8 office J test Apply saved settings x Comments this is my comment 2 SA E F Restart lagg
13. open the file again make changes and save it this procedure will be adhered to in the audit trail file Modifications are updated immediately in the view The preset path for saving is User s personal files Once stored in this directory files are no longer accessible for other ComSoft users and can no longer be opened even if they are moved to the directory Documents and Settings All Users Documents Testo Data Area 39 Electronic signature 40 In order to be able to sign a file this must first be saved Under Extras select Sign file and select the meaning of the signing Meaning of the signing You are about to sign this file using your digital certificate The meaning of the signing is required Cancel th Meaning of the signing Authorship Responsibility x When a file is selected in the Data area Archive you can call up signature details for this file with Check signature only when used with certificates This will show the author the meaning of the signing date and time At the same time the validity of the corresponding certificate will be checked Note The signature of a file is made up of UserlD Date Time possibly Certificate and meaning Depending on the system constellation the full user name for ComSoft may not be available if the full name is not automatically displayed it has to be entered separately in the Username or Name box Editing an electronic record Instr
14. single hard disk provided that you keep the original solely for backup or archiving purposes You are not permitted to reverse engineer decompile or disassemble the software Testo GmbH amp Co Lenzkirch may take legal action against you for aA breach of property rights by you or by any person acting directly or indirectly under your authority 5 t Limited guarantee Testo guarantees for a period of 90 days from purchase of the software by the buyer or for a longer minimum period if such a period is prescribed by the laws of the country in which the product is sold that the software conforms to general standards defined in the accompanying documentation Testo expressly does not guarantee that the software will operate without interruption or without errors Should the software not function according to the accompanying documentation when in normal use the buyer will have the right to return the software to Testo within the warranty period and to inform Testo in writing of the deficient functional capacity Testo will only be bound to make a functional gopy of the software available to the buyer within a reasonable period of time from receipt of the notification of functional incapacity or should a copy not be available for any reason to reimburse the buyer for the purchase price Any warranty in respect of the software the associated manuals and written material extending above and beyond the limited guarantee outlined above is excluded
15. 003 08 07 49 44 10 21 20 20 01 2003 08 07 52 60 30 21 50 20 01 2003 08 07 55 85 60 22 50 20 01 2003 08 07 58 93 80 23 30 20 01 2003 08 08 01 95 50 23 80 20 01 2003 08 08 04 89 00 22 80 10 20 01 2003 08 08 07 66 90 22 80 ii 20 01 2003 08 08 10 56 90 22 80 12 20 01 2003 08 08 13 50 50 22 80 13 20 01 2003 08 08 16 47 50 22 80 his now covers the full content of the completed header of a stored electronic record he corresponding ancillary data will have been registered in the Editing an electronic record With the addition of columns of calculated values to the table e g the addition of a dewpoint calculation the cutting out of data or partial copying the description Original in the header changes to Refined manually Serial 508 1897 0049 Instrum 171 2 State Refined manually Page this is my comment Reason for logging Date Username cfr cfr Name Signature Authorship cfr 20 01 2003 08 12 05 D Documents and Settings All Users WINNT Documents Comfort Software archive office vi2 a a 2 1 20 01 2003 08 07 40 44 20 21 20 8 55 2 20 01 2003 08 07 43 44 10 21 20 8 51 3 20 01 2003 08 07 46 44 10 21 20 8 51 4 20 01 2003 08 07 49 44 10 21 20 8 51 5 20 01 2003 08 07 52 60 30 21 50 13 49 6 20 01 2003 08 07 55 85 60 22 50 19 98 7 20 01 2003 08 07 58 93 80 23 30 22 25 8 20 01
16. 1715 43 52 c1 58 5 c2 23 799999 c3 15 159014 gt row Date 2002 12 117T15 43 54 ci 52 c2 23 6 c3 13 163482 gt Praw Nate 9NN2 19 1147165 49 8K ol A7 SQ000R 9 99 4 eal AKDA A o For reasons of security against falsification it is not possible to reconvert the data from this format to the native vi2 format of the Comfort Software 47 Audit trail 48 In addition to the restriction of permitted users the possibility of granting various rights and the securing of stored records by access restrictions to the archive area the audit trail is one of the major supports for the demonstrably secure storage of electronic records The system audit trail is made available by the operating system used Depending on the settings at system level all relevant actions carried out on the PC laptop are recorded and are available in the system audit trail for later investigations In the system audit trail based on the Windows EventLog all actions are recorded that have an effect on the complete system These include login logout managing the archive data area user management changing the system configuration Unlike the system audit trail there is a file audit trail that collects entries that can be directly allocated to a data file electronic record These include the creation or saving of electronic records and any changes made to these data during the arc
17. 2003 08 08 01 95 50 23 80 23 02 9 20 01 2003 08 08 04 89 00 22 80 20 89 10 20 01 2003 08 08 07 66 90 22 80 16 34 11 20 01 2003 08 08 10 56 90 22 80 13 83 12 20 01 2003 08 08 13 50 50 22 80 12 02 13 20 01 2003 08 08 16 47 50 22 80 11 06 43 Printing data out on paper In a paper printout the header includes all CFR related data and there is a field for an additional handwritten signature Note lf the path display is not displayed or printed in its complete form we recommend you use a smaller font or the landscape print function Note Please note that the statistical values given in the printout refer to the time range selected and marked in the diagram or table nstrument 171 2 is is my comment p08 1897 0049 ptate Refined manual Mint 11 96rH humidit 22 C 42 10 temperat 21 20 Reason for logging ate sername 20 01 2003 ffr cfr uthorship cfr 20 01 2003 08 12 05 Documents and Settings All Users WINNT Documents Comfort Software archive office vi2 20 01 200 pooi aanp 20 01 200 bo o1 200 8 09 5583 40 21 60 In a tabulation covering a number of pages the storage location and page numbering of the document are inclu
18. Individual rights for user groups s E mail address for alarm and warning MESSAGES eee 31 Time zone during online measurement eect eeeeteeetteee eee 32 Data logging with testostor 171 as an example dd Setting UP rerien iaia 18 Programming 1138 REE O ROTI EE steancdiacsaiisnebnastamensesaucsetitvaes 37 Saving data creating an electronic record 39 Electronic signature i Editing tai electronig FE CON issiran nanna 41 Printing data out On paperiin nia naiiai aE 44 Batain aH PDE TS tise aesa na aE iis shaet ievvameseed s 46 Exporting data in XML format ccceeeeceeeeeeeeeeetteeeetteeeeeneeeees 47 Audit trail a SystemauditMallsese aaen ERN 49 PIG AUGit trail riiai iaa i 52 Error messages 54 VESON Serasa E EEE A EEAS TAES 56 SONICS sinir OF TESTO WOR WIKE csscscssatieastengndpragsqaneann ase aunsads nannaa aeiaai 58 Proper use The ComSoft 3 software enables individual measured values and series of measurements to be saved read out and evaluated The CFR version was especially developed to fulfil the requirements of the FDA regarding the storage of data in accordance with 21 CFR Part 11 when working in conjunction with Testo data loggers In the first place comes user access control For this ComSoft CFR uses the security mechanisms of the Windows NT operating system A system administrator with special rights must set up the ComSoft CFR software during its installation with the help of th
19. Istu f MKHBINB Dinformad 30 07 20 11 07 53 Comsoft Instru f MKH INB Dinforman Comsoft Istu ci MKHB INB Dinformat Comsoft Applica 25 ci MKHE1NB Dinforman 4 Oakley None 2 MKHB INB Dinforman O 06 31 47 Oakley None MKH21NB D informas 13 56 06 Oakley None MKHB NB Dinforman 13 51 39 Oakley None MKHBINB Dinformats 06 37 14 Oakley None MKHB INB D nformat 19 49 51 Oakley None MKHB NB Dinforman 21 28 43 Oakley None MKHB INB Pinformat 2 21 00 00 Oakley None MKHB INB Dinformap 26 07 20 19 45 51 Oakley None MKHBINB Since after working for only a short time there can already be many entries here there is a facility for sorting the individual columns so that a preselection in the relevant range can be made In the first column the type of event can for example be sorted by information warning or error A sort by date and time displays the actual event history Note The time marks which identify each action come from the system time which takes effect directly If you include all the time zones you will have to guarantee the corresponding world time reference using the appropriate SOP 49 System audit trail 50 Finally under Source the entries from the Comfort Software can be grouped together All entries are also numbered and include the responsible user and the system on which the entry was made A double click on any entry or right clicking on Properties will open a detailed descriptio
20. Software 21CFR Part 11 testo ComSoft CFR 3 4 Instruction manual oe 5 d Sy Where Know how connects Copyright This documentation is subject to the copyright of Testo AG Reproduction and use contrary to the legitimate interests of Testo AG are prohibited without the prior written consent of the company We reserve the right to modify the technical details described specified and illustrated in this documentation Testo AG Postfach 11 40 79849 Lenzkirch Germany Introduction Dear Customer We are delighted you have chosen a product from Testo We hope that the product will give you a long period of satisfaction and will aid you in your work Please read this instruction manual carefully and familiarise yourself with the operation of the unit before putting it to use If problems should occur which you cannot rectify yourself please consult our service department or your dealer We will endeavour to provide fast and competent assistance to avoid lengthy down times Licence Agreement This is a legally valid contract between you the end user and Testo When you or a person authorised by you opens the sealed CD ROM package you recognise the provisions of this contract If you do not agree with the terms and conditions you must immediately return the unopened software package with the accompanying items including all written documents and other containers to the place from which you bo
21. aceutical industry may also be handled electronically and regulate the use of electronic signatures in the place of traditional handwritten signatures All pharmaceutical companies who wish to sell their products on the US market and who manage electronic data records and electronic signatures in their production processes together with the associated accountability must meet the requirements of 21 CFR Part 11 During an inspection by the FDA the fulfilment of these requirements is actively verified and failure to fulfil them leads to corresponding blocking notes General information 21 CFR Part 11 and terminology used Who must fulfil these regulations All companies or manufacturers that market or intend to market their pharmaceutical products in the USA must fulfil these requirements What are the possibilities especially in the area of measuring techniques and data logging Compliance with 21 CFR Part 11 Such compliance means fulfilling requirements that are above all organisational but are also partly technical Fulfilling organisational requirements means that pharmaceutical companies will set up organisational structures and define describe and document all processes in order to demonstrate what protective measures are used by the company in order to comply with the regulations and how they are enforced The core of such documentation consists of SOPs standard operating procedures which describe and regu
22. ded so that even wi large amounts of data the source of the printout remains clear 44 Printing data out on paper In the diagrammatic representation the data can be printed out periodically structured for greater clarity i e one page corresponding to one day one week or one month This function can be found with a right click on the diagram under Printout Settings Entries can be made for the print range and the diagram page width in sec min h or days is is my comment 2 C tem 13 td C td T 21 20 24 50 22 21 8 51 23 81 10 50 Reason for logging 20 01 2003 uthorship cfr 20 01 2003 08 12 05 BitDocuments and Settings All Users WINNT Documents Comfort Software archive office vi2 20 15 10 2o oaf2003 td C 08 06 00 10100 08 14 00 os 1k 45 Data in a PDF file 46 For long term data storage it is recommended that ComSoft file data should be exported into the ADOBE R PDF pdf format These can be write protected and saved in a backed up folder or written to a CD ROM making the data accessible from outside the ComSoft application years later To do this you will need ADOBE Acrobat 5 0 or higher Instead of sending the data to an installed printer you can divert them to the Acrobat Distiller which then generates the corresponding PDF file Exportin
23. e Windows security settings These include above all the allocation of the users to the local groups The allocation of the user IDs and passwords and of user rights and the regulation of document flow within the company must comply with the organisational guidelines as laid down The ComSoft default security settings correspond to the requirements laid down in 21 CFR Part 11 It lies largely within the responsibility of the operating organisation to ensure that the appropriate access rights are made available to its individual users Testo is not responsible for the consequences at operating system or application program level of errors in the allocation of user rights In addition to the special software the hardware must also be adapted in this respect i e the Testo data loggers used must be equipped with password and serial number functions The following families of Testo instruments are suitable for use in a 21 CFR Part 11 environment in combination with ComSoft CFR testostor 171 testo 175 testo 177 For each of these data loggers there is a matching device driver that is especially adapted to the capabilities of the instrument hardware and its control The data loggers are programmed with the ComSoft CFR software and can then record measurements independently The collected measurement data are then transferred to a PC via a serial interface The data are also read out using the ComSoft CFR software which activates the inter
24. e installation you must allocate individual users who are to work with the program to one of the above named groups The following procedure applies in particular to the installation or operation of ComSoft within a company network e g data filing on a Fileserver Server Domain 1 2 Set up server directory for data filing Set up global user group s e g ComSoft Admin Comsoft Main User and ComSoft User 3 Allocate group members 4 Set up security configurations for server directory grant respective access to Global Groups PC 5 Install Comfort software on PC local 6 When installing set up the filing location for data filing on the server directory Include Global Group s as member in local Testo Comsoft group s Carrying out the installation To install the USB driver please read the separate docu a mentation included with the USB driver CD Administrator rights are required in Windows 2000 XP and Vista to install the program First uninstall remove any earlier installations of old versions of ComSoft Edt View Favorites Tools Help v amp Qsearch GiFolders Bristory Control Panel 3 Ev Accessibility Options BaddRemove Hardware fJAdd Remove Programs Administrative Tools EFECAN Hardware pa E Display Fax OJ Folder Options Fonts Game Controllers Internet Optic gt a S Phone and Modem Options Haz Add Remove Programs E 4S era f
25. elected user Users and Passwords 2 x Users Advanced Go Use the list below to grant or deny users access to your computer and to change passwords and other settings IV Users must enter a user name and password to use this computer Users for this computer Administrators Testo Comsoft Admins Admi Guests Testo Comsoft PowerUsers Testo Comsoft Users Power Add Remove Properties Password for Administrator To change the password for Administrator click Set Password Set Password eo 19 Access control at the system level By clicking on the Properties button and selecting the Group Membership tab you can also change the allocation of the user to one of the three user groups PINS Admistrtor Properties 2 General Group Membership User name i Full name DOO O Description Built in account for administering the comp Testo Comsoft Admins xi 20 Access control at the system level Adding a user Double click on Users and Passwords and then click on the Add button to start a wizard that will guide you step by step through the input fields thus allowing you to add all the details of the new user Here you enter the user ID and the full name of the user In description you can enter further information about the user such as position or responsibility Click on Next to change to the next window where you must enter the password for this use
26. es 10 Open an existing document Allows the user to open electronic records that have already been Officially saved 29 ComSoft access control 11 Program instrument This enables the instrument to be reprogrammed any data and programming parameters stored in the instrument are lost 12 Read out logger Reads the original data and programming parameters from the instrument and displays them for viewing 13 Restart with current settings Restarts the instrument with the programming parameter settings this creates a new log entry 14 Save instrument settings 15 Can save active document under new name Deactivating this property makes it difficult to generate electronic records with freely chosen file names 16 Can save active document Allows electronic records to be created from the work area Note In order for example to prevent any creation of electronic records both Save positions must be deactivated 17 Sign file Gives the user signature rights 17 Deleting a row Security settings A Login policies apf Signing policies Z Calibrate instrument 2 GB User rights F Change security settings Testo Comsoft Admins Z Create a new formula G Testo Comsoft PowerUsers 7 L Testo ComsottUsers MJ Erase the selection Z Open an existing document Pseve instrument settings MW Save the active documentwith anew name M Saves active document
27. es on Local Machine 83 Account lockout duration Not defined amp Account lockout threshold O invalid logo fg Reset account lockout cou Not defined Under Account lockout threshold the number of failed logon attempts can be set after which renewed attempts will be blocked The lockout can be reset after a defined duration and the duration of account lockout can also be set here Local Policies this is where monitoring policies can be set TE action vew e eml Be Policy Y Audit account logon events 3 Audit account management No auditng No audtng 2 Audit directory service acc No auditing No auditing 2 Audit logon events No auditing No auditing G9 Account Policies G9 Local Policies 23 Audit Policy G9 User Rights Assignment Security Options a Pubic Key Policies BY 3 amp IP Security Polcies on Local Machine Audit system events No auditing No auditing 24 Access control at the system level Under Local Policies User Rights Assignment detailed user rights can be set QAccess this computer from Everyone Users Everyone Users p A Act as part of the operatin Account Policies x 29 accou Be Add workstations to domain G Loca Poles BYBack up fles anddrectones Backup Operat Backup Operat Audt Policy Bypass traverse checking Everyone Users Everyone Users User Rights Assignment Echange the system
28. f Sounds and t Sort by Name Currently installed programs iB ATI Display Driver Utilities a amp Paint Shop Pro 7 Size 112MB sQ Palm Desktop Size 13 4MB I Sophos Anti Virus version 3 59 Testo Comfort Software for 21 CFR part 11 Sea 1LeMB Programs LastUsedOn 20 01 2003 A To change this program or remove it from your computer click Change Remove S Change Remove Add Remove UER i Testosync Components B Close eS Installs and removes programs and Windows components KE My computer Uninstalling software Select Start gt Settings gt Control Panel gt Software gt Testo Comfort Software Click on change remove Installing Testo Comfort Software for 21 CFR Part 11 1 Insert CD ROM in the drive 2 After a short wait the installation program will start automatically If it does not double click on Setup exe in the corresponding directory on the CD ROM 3 You will be asked to enter the licence number see sticker on CD case Note If the number entered is not accepted has the caps lock key been pressed by mistake were you using the number keypad without num lock active did you enter by mistake instead of 1 did you enter o by mistake instead of 0 15 Carrying out the installation 4 In the following steps you can choose whether to install the Comfort Software in a standard directory or to choose one of your preference You can also choo
29. faces and makes any other functions available Proper use The logged data together with date and time are tabulated in a special 21 CFR Part 11 form unmodified original data and data that have been processed for example for better comprehension can be distinguished and appropriately marked 21 CFR Part 11 places special requirements on the responsibility of the user operating organisation of the complete system consisting of PC and one or more data loggers In this sense the solution made available by Testo is to be seen as a tool that contains all the necessary aids for implementing a validated measuring system within the FDA regulations and for managing the electronic records that it generates Proper use in this context means above all that a set of SOPs standard operating procedures is drawn up for the use of the data logging system which ensure that the tool consisting of Testo Logger and ComSoft CFR is operated correctly These SOPs are to be adapted to the particular organisation and purpose of use and together with the Testo measuring system form the validated measuring system required by the FDA in 21 CFR Part 11 for the creation of electronic records authenticated where required by electronic signatures In particular the user operating organisation is responsible for instruction and training of operators Testo can only provide the necessary basic material in the form of the present instruction manual
30. g data in XML format lf the data are to be available long term for processing outside the Comfort Software you can select Save as XML in the File menu The data will then be saved in this form lt rs data gt Saai ype lt s AttnbuteType name c2 rs name K 2 C Temperatur rs number 3 rs nullable true s wnte true gt lt s datatype dt type r4 dt maxLength 4 rs precision 2 rs fixedlength true rs maybenull false gt AttnbuteType gt tnbuteType name c3 rs name K 3 td C td c true gt e dt type null false gt s AttnbuteType gt lt s extends type rs rowbase gt lt s ElementType jumber 4 rs nullable true it maxLength 4 rs precision 2 rs fixedlength true lt s Schema gt lt z row Date 2002 12 11T15 43 32 lt z row Date 2002 12 11T15 43 34 c1 lt z row Date 2002 12 111T15 43 36 c lt z row Date 2002 12 111T15 43 38 ci 61 900002 lt z row Date 2002 12 11T15 43 40 72 599998 c2 22 9 c3 17 728661 gt row Date 2002 12 11115 43 42 c1 81 5 c2 23 299999 c3 19 975435 gt lt z row Date 2002 12 111715 43 44 c1 86 900002 c2 23 700001 c3 21 376755 gt lt z row Date 2002 12 117T15 43 46 ci 90 199997 24 1 c3 22 379744 gt w Date 2002 12 11T15 43 48 c1 85 599998 c2 24 c3 21 412882 gt row Date 2002 12 111715 43 50 c1 69 199997 c2 23 9 c3 17 911951 row Date 2002 12 11
31. hiving period Authorisation modifications are also documented The file audit trail data are coupled directly with the data file and inseparably bound to it This ensures that even when transferring data files from one system to another the trail data are not lost and always remain fully available System audit trail The access to the system events is available in the Comfort Software application by selecting Administrator Display audit trail in the Tools menu System audit trail Testo Comfort Software CFR Fie Instrument Edit View Insert Format Tools Window e US me oo a m Filename Comments archive Files PDAhendheld Semple tiles 2 testostor 71 508 1897 7 amp Bus connection This will open the Application Log in the Windows Event Viewer showing the entries registered in relation to actions in the Comfort Software Aton yew Olm e hR e Tree Appication Log 203 event s fig Event Viewer Local Date Source Category Event User Application Log Dinformat 30 07 20 11 25 54 Comsoft Irstu cfr MKHE INB E Securty Log informan 30 07 20 11 25 02 Comsoft retu ch MKHB INB i System Log Dinformad 30 07 20 11 24 45 Comsoft Applica of MKHBINB ee Dinforma 30 07 20 11 14 01 Comsoft Istu f MKHB 1NB Dinformaw 30 07 20 11 08 35 Comsoft Trstu f MKHBINB Pinformat 30 07 20 11 08 02 Comsoft
32. idual features each of which is marked with a tick when clicked on and thus made accessible for the selected user group ComSoft access control In detail the following rights can be granted withdrawn 1 Calibrate instrument This allows data loggers with humidity probes to be calibrated at 11 RH and 76 RH 2 Change security settings Allows security settings to be changed Note Normally only the ComSoft Admins group has write access to the access control data file When required access to the following directory must be granted lt CSIDL_COMMOM_APPDATA gt testo comfort software On Windows 2000 this is usually C Documents and Settings All users Application Data hidden in the basic settings of Windows 2000 3 Create a new formula This enables the function or fx entry in the menu or toolbar so that channels derived by calculation can be added to the existing measurement channels Note Remember that when this function is introduced original measured data can be manipulated In the simplest case this would mean shifting an existing temperature curve by an arbitrary offset However such calculated channels are in any case additional i e the measured data used can be blanked out but not replaced by the calculated data 4 Delete a row 5 Delete item 6 Displayaudit trail Allows the user to view the system audit trail 7 Edit formula 8 Edit limits 9 Erase the selection Deletes the marked rang
33. ing E New start time E 01 03 07 47 51 Closing Right click on the logger symbol and select Close in the shortcut menu the data logger can then be disconnected from the interface PC Data logging with testostor 171 as an example Reading out During the measurement or after the stop criterion has be reached you can view the content of the data logger memory as follows Connect the data logger to the interface and double click on the logger symbol to open the logger the record in the memory will appear with the character string entered under Title Double click on this record to display the data A right click on the record enables parts of the memory to be read out does not apply for circular buffer operation Testo Comfort Software CFR Fie Instrument Edit View Insert Format Tools Jee almal Oo aE Id H i a archive 4 Files 2 PDAhandheld Semple files J testostor171 508 1897 Busc Read out data and open Read out selection Ba Copy The data in the opened file are displayed for editing in the right hand part of the window 37 Data logging with testostor 171 as an example 38 Testo Comfort Software CFR office F fie Instrument Edt View Insert Format Tools Window jeHSQR 420 mev eo Moe u Ofcrri n Fl lasar sik Instrum 1741 2 serial__ 508 1897 0049 Filename Comments State original as this is my comment
34. ive Tools File Edit View Favorites Tools Help Back gt QSearch Folders BHistory 85 OS X A Ev Address Administrative Tools s Se ll p Da Compon Computer Event Eee g Perform Services Telnet Services Manage cas Viewer Security Server Policy Under Account Policies Password Policy you will find all the possible settings for passwords F Local Security Settings pe a 15 x Acton vew e gt om B Tree B Security Settings amp Enforce password history is passwords O passwords remembered 82 Maximum password age 42 days 42 days pot ia x 3 Mnimum password age O days 0 days ssword Policy 3 Minimum password length O characters O characters Ba Account Lockout Polcy Passwords must meet com Disabled Disabled G Local Policies Store password using reve Disabled Disabled Public Key Policies IP Security Policies on Local Machine 23 Access control at the system level The important ones are minimum and maximum password age minimum password length and number of digits Under Security Settings Account Policies Account Lockout Policy you can set security parameters for logging on E Local Sec urity Settings Acton view amp Tree E Security Settings 5 09 Account Policies 9 Password Policy 23 Account Lockout Policy 9 Local Policies E Public Key Policies H IP Security Polici
35. late all processes These describe in detail how the responsible persons are to carry out processes and use systems in order to achieve the required results Fulfilling technical requirements the fulfilment of technical requirements is based on the use of products that have been adapted by manufacturers for use in this area This includes the ComSoft CFR system according to 21 CFR Part 11 as described here together with the appropriately approved Testo data loggers Only when suitable technical systems are combined with the appropriate SOPs for the process in question is proper fulfilment of the FDA requirements guaranteed for the manufacturers of pharmaceutical products for the US market However this also means that the use of technically suitable products such as the Testo system does not in itself fulfil the FDA requirements this can only be achieved by integrating the measuring technology in an organisation established in compliance with 21 CFR Part 11 together with company specific SOPs General information 21 CFR Part 11 and terminology used 10 What providing suitable systems available means for Testo wherever possible we seek to meet the requirements at the technical level in order to reduce the number of SOPs needed within the company to a minimum This is the task of our system and also the subject of this instruction manual which should help you to identify critical processes in data logging and archi
36. mfort Software CFR together with various Testo data loggers in a validated process or a validated total system The Testo installation program links the Comfort Software program with the Access control mechanisms of the NT operating systems The systems supported are Win 2000 XP Professional Vista Business Enterprise Ultimate Internet Explorer 5 or later is required The installation program requires administrator rights Whilst installing the program the installer sets up local groups in the system administration 3 local groups are added to those already present Testo ComSoft Admins Testo ComSoft Power Users Testo ComSoft Users sets the path for file storage Here the default setting C Documents and Settings All Users Documents Comfort Software Professional can be modified appropriately It is necessary to grant the groups named above full access to this directory It is necessary to grant full access to the above mentioned groups for this directory 13 Information for the administrator 14 If only ComSoft users are to have access to this directory it must be expressly barred to other users When granting access rights pay attention to the rights granted for higher level directories Rights to higher level directories determine the extent of access to sub directories which are registered by the Comfort Software as a source of log entries audit trail and event logs After th
37. n edition is clearly marked on the last page of this Instruction Manual This first version has the number 0971 0436 T ind PC_qxd 01 03 In later versions modifications will be listed below Date Page Chapter 313 04 03 16 Carrying out the installation X 33 04 03 32 Data logging with testostor 171 time zone as an example x 33 04 03 36 Data logging with testostor 171 as an example X S3 04 03 41 Editing an electronic record 2nd signature X 33 04 03 60 Version number X 3 4 12 03 38 Production number Serial number X 3 4 12 03 39 Saving in directories without deletion authorisation x 3 4 12 03 39 Direct Update X 3 4 12 03 39 File created X 3 4 12 03 39 MD5 Checking sequences X 3 4 12 03 40 Enter full name X 3 4 12 03 44 Path display incomplete xX 3 4 12 03 48 Authorisation modification xX 3 4 12 03 52 File Audit Trail X 3 4 12 03 53 Export function X 3 4 12 03 57 Service data for ComSoftCFR 21 X 3 4 12 03 60 Version number X 3 4 01 60 Version number X 3 4 02 12 Minimum system requirements X 3 4 02 13 Information for the administrator X 3 4 02 15 Carring out the installation X 3 4 02 44 Printing data out on paper X 3 4 02 60 Version number X 56 Service Please contact us if your Testo instrument fails to function One of our highly qualified and experienced technicians will help you Data for ComSoft CFR 3 4 Please have the following information ready Select question mark in the toolbar Select
38. n of a data record General information 21 CFR Part 11 and terminology used Every action affecting an electronic data record is recorded together with a unique user ID and date time Paragraph 11 10 draws special attention to the obligation to keep all persons concerned in the creation processing and archiving of electronic data records up to date with regular training in order to ensure that these persons have the necessary knowledge to use the required systems and procedures correctly With regard to the implementation of the technical requirements in the Testo system of Comfort Software and data loggers reference will be repeatedly made throughout this instruction manual to the text of 21 CFR Part 11 in order to show how various detail functions are implemented in the context of 21 CFR Part 11 11 Minimum system requirements 12 PC with operating system Microsoft Windows 2000 Service Pack 4 XP Service Pack 2 or Vista 32 Bit Microsoft Internet Explorer 5 01 Prozessor min Intel Pentium Ill 8OOMHz RAM min 128MB for Windows 2000 and XP 1 GB for Vista CD ROM drive for installation mouse USB 1 1 interface or free serial interface COM Monitor resolution min 800 x 600 Pixel recommended 1024 x 768 Pixel Hard drive min 50MB free memory Note The ComSoft CFR software does not run on earlier Windows versions Windows 9x Win 4 x These operating systems do not p
39. n of the event Hevent viewer Mee Action View e Omi sFh amp B e 1 Refresh Application Log _203 event Properties 11 D Informat Heb DInformat 3 Informati D Informat D informab D Informat Dinformat f System Log DInformat 7 Dinformats 30 07 20 4 Under Description is a detailed description of the action carried out by the user The Up Down arrows can be used to scroll through the detailed descriptions Event i xl Dote 30 07 2002 Source Comsot Time nos Cotegory Instrument Type Information EventID 258 User MEE ES Computer MKHBINB Description 171 25035026 0075 Clock resynchronized Cancel By selecting Properties in the Action menu the general information about the application log can be viewed Under the Filter tab the recording of particular types of event first column can be activated and deactivated A preselection here helps to keep the size of the application log within reasonable bounds System audit trail Application Log Properties General Fiter Eventtypes Information F Waming F Eror Event source Category EventID User Computer 2x F Success audit F Failure audit Application z From First Event zif 0 Ms To Last Event Restore Defaults le Le Seal awa Under General are the settings for the actual log file may
40. ols and then on Computer Management 16 Carrying out the installation You can also obtain information on the use of Local Users and Groups by clicking on Help in the Action menu of the Computer Management window You can find details in the chapter Access controls at system level Note Only users who are administrators or members of the above named groups can start the ComSoft CFR program it is the responsibility of the system administrator to ensure that each password is only used once i e two users may not work with the same password Remember also that changes to the security parameters affect the whole system and influence other applications After a successful installation 7 Once installed the Comfort Software must first be started by the administrator in order to make any settings required e g opening a Comfort Software file vi2 directly from the Explorer with ComSoft starting automatically You should also check direct access to the Data Area directory e g by using Save As 8 Finally you can change the standard settings for rights within the ComSoft application for the 3 user groups see p 30 General information for the ComSoft CFR user The descriptions and chapters of this instruction manual relate specifically to the requirements of 21 CFR Part 11 The standard functions and general use of the software is covered in greater detail in the instruction manual for ComSoft
41. or All signatures can be reproduced in the File audit trail The last two signatures and not just the last are displayed in the protocol heading 41 Editing an electronic record 42 Instrum 171 2 Serial__ 508 1897 0049 Page State Original this is my comment Reason for logging Date Username cfr cfr Name Signature Authorship cfr 20 01 2003 08 12 05 D Documents and Settings All Users WINNT Documents Comfort Software archive office vi2 z system and in the audit trail file You can now make further modifications to the appearance or representation of the data without changing the original data character the basic data are retained In case of doubt you can use the right mouse button file name shortcut menu and select the function Reset to basic settings to return to the original display Editing without changing the original data includes adjusting the scale changing the plot lines switching between tabular and graphic view highlighting measured points adjusting the representation of limit values adding further comments to the comment field or the graphical representation office Date Time Yer H humidi C temperature 1 20 01 2003 08 07 40 44 20 21 20 20 01 2003 08 07 43 44 10 21 20 20 01 2003 08 07 46 44 10 21 20 20 01 2
42. r and confirm by entering it again x Type and confirm a password for this user Password an Confirm password To continue click Next lt Back Next gt Cancel 21 Access control at the system level 22 In the last window comes the allocation to one of the three user groups Click on Other and open the dropdown list of available possibilities for the Testo ComSoft application you will find three possible user groups Admins Power Users and Users c x What level of access do you want to grant this user Standard user Power Users Group Users can modify the computer and install programs but cannot read files that belong to other users Restricted user Users Group Users can operate the computer and save documents but cannot install programs or make potentially damaging changes to the system files and Other Testo Comsoft Users lt Back Finish Cancel Complete the process by clicking on Finish The allocation of the detailed individual rights takes place in the Comfort Software application where the rights granted apply to all members of the user group in question Access control at the system level Individual parameters Here you can define the boundaries of the local security and set the necessary control parameters Open Start Settings Control Panel and open Administrative Tools double click on the icon Local Security Policy 4 Administrat
43. r laptops is not to be recommended multiple system audit trails In the event that you do nevertheless read out the data logger with a different laptop PC from the one with which it was programmed you should enter a remark at this point so that the audit trail data can later be merged together Check under Options below whether in addition to humidity and temperature you wish to add other measured quantities to the saved data You should also check the logger time if required this can be synchronised with the PC laptop system time Note For reasons of handling there is no express warning message when the logger time differs from the PC time Check the logger time under Options if the situation requires it e g changing from summer to winter time time zone change following transport Data logging with testostor 171 as an example x General functions coe I Accoustic signal when measunng I Accoustic signal out side limits Humidity calibration Change password Date and time Units Calculation Logger 040902125026 Tomp E tases Synchronize fc gt F Dew point Change password introduces an additional password for the logger once allocated this must be given with every communication with the logger Note If an empty no characters typed password is entered the password request will be deactivated If you now select Measuring program in the main window the following window will
44. rovide the necessary facilities in the area of security settings user ID and password and are suitable for use in CFR related environments only under limited conditions For the purpose of this instruction manual specific Windows security settings are described with reference to Windows 2000 Professional The procedure for other permissible operating systems can differ in certain respects In order to export files in pdf format Adobe Portable Document Format you require as additional software Adobe Acrobat 5 0 or higher if compatible Via the clipboard using copy paste or by direct drag amp drop you can also export data to other programs e g Excel in connection with 21 CFR Part 11 this is only advisable in our opinion if you already have extensive in house guidelines for working and saving data with these programmes Information for the administrator One of the main points in the 21CFR Part 11 regulation deals with controlled system access The background to this is the fact that so called closed systems i e clear small system units with only a few precisely defined external interfaces and a defined group of authorised users can be easily controlled with a small number of SOPs As in practice the responsibility for allocating user accounts and user rights lies in the hands of administrators the following information is addressed to the administrator or the group of people authorised to integrate the Co
45. se the directory in which the data files will later be archived The installer will propose the name Testo for the program directory here too you can choose your own name Note The preset path for saving is user s personal files This is determined by the MFC class library the Windows version and the set up data at operating system level it is not recommended to attempt to make changes here Once stored in this directory files are no longer accessible for other ComSoft users and can no longer be opened even if they are moved to the directory Documents and Settings All Users Documents Testo Data Area 5 The remainder of the procedure is menu guided Please observe the instructions and explanations beside the buttons Note ETE lt A second alternative procedure has been Sa added to the electronic signature Unlike the ee signature with certificate only the registration authentification is used for this slimmed down version The procedure which can be used is determined during installation The simple signature is also registered in the file audit trail and is available in the file heading for printing purposes However the Check signature function cannot be run in Tools The signature by certificate offers greater security which is why this version is recommended 6 To open the Computer Management click on Start point to settings and then click on Control Panel Double click on Administrative To
46. ted operations the system trail must also be included 53 Error messages The connection could not be established 54 e Make sure that the instrument is switched on e Check the connection cable e Check whether the instrument is in the main menu This message appears if the PC program cannot communicate with the connected measuring instrument or if the measuring instrument does not respond Is the instrument switched on Does the instrument have sufficient power Is the connection cable connected Is it the correct connection cable Is it connected to the right COM port Is the menu on the instrument called up MENU key Have you pressed the Menu key Error messages Invalid name The symbols cannot be used in measurement location and folder names Rename it and do not use these characters An instrument setting with this name already exists Different names should be used when setting up new instruments The same name should not be used for different instruments Please select a new name The time ranges overlap You are trying to connect records using invalid data Certain overlapping time ranges cannot always be merged in a common record If we were unable to answer your question please contact your distributor or Testo Customer Service You will find contact details in the Warranty booklet or in Internet at www testo com 55 Versions The versio
47. time Power Users Ad Power Users Ad S G Security Optons BY Create a pagefile Administrators Administrators Gi Pubic Key Policies Zi Create a token object amp IP Security Policies on Local Machine amp Create permanent shared Debug programs Administrators Administrators Ber access to this compu BY Deny logon as a batch job E Deny logon as a service Ba Dery logon locally 2g Enable computer and user B Force shutdown from are Administrators Administrators E Generate secunty audits Bincrease quotas Administrators Administrators Bincrease scheduling priority Administrators Administrators 23 Load and urload device dri Administrators Administrators BaLog on localy MKHB INB Gues MKHB INB Gues 22 Manage auditing and securi Administrators Administrators Zi Modfy firmware environme Administrators Administrators Profile sngle process Power Users Ad Power Users Ad BAProfie system performance Administrators Administrators ARRemove computer from d Users Power US Users Power US BReplace a process level token E Restore files and drectories Backup Operat Backup Operat Shut down the system Users Power Us Users Power Us aSynchronize drectory servi BiyTake ownership of files or Administrators Administrators This is where computer related user rights can be set e g who should have the right to log on locally or via the network 25 Access control at the system level
48. ts State Original this is my comment Beason for loqaing S let El Actual size 24 23 22 20 01 2003 20 01 2003 20 01 2003 20 01 2003 08 09 00 0 00 08 11 00 08 12 00 s 08 10 a ee ec For help press FE Data logging with testostor 171 as an example Saving data creating an electronic record You have read data out from a testostor 171 data logger and these are displayed on the PC as a chart or table In order to save the data and create an electronic record click on File Save as and choose a directory and file name the program will automatically propose the title entered when programming the logger This name appears in Audit trail after file created 2852 Se 00 amp BOM CFR zrn Roark ai xi 5e Sevein Comtor Sofware Professonal for 21 CFR w cf Ee nm Office s c Fienone E Saveastype Comsot Standard vi zj Cancel TT 30 ly Ty Note The data will be saved in a special binary coded format vi2 This format is additionally saved via an MD5 sequence making it impossible to process or falsify these files outside the ComSoft application The files can be saved in directories for which the respective user has no deleting authorisation After saving you will find under File File audit trail the audit trail for this stored record in the simplest case this shows the date and time of saving If you
49. ught the software which will give you a full refund of the purchase price Granting Of a licence This licence entitles you to use a copy of the Testo software which was acquired with this licence on a single computer subject to the condition that the software is only ever used on one single computer at any one time If you have bought multiple licences for the software you may only have as many copies in use as you have licences The software is in use on a computer if it is loaded in the intermediate memory or RAM or stored on a permanent memory e g a hard disk of this computer with the exception thatia copy which is installed on a network server for the sole purpose of distribution to other computers is not in use If the foreseeable number of users of the software exceeds the number of licences acquired you must ensure through the necessary mechanisms or procedures that the number of persons using the software at the same time does not exceed the number of licences Copyright The software is protected against copying by copyright laws international agreements and other legal provisions You may not copy the software the handbooks for the produetxor any other written documents accompanying the software The software may not be licensed let or leased to third parties If the software is not fitted with a dongle you may either make a single copy of the software solely for backup or archiving purposes or transfer the software to a
50. um 174 2 Serial__ 508 1897 0049 Page State Original this is my comment A data record that has been read out of a logger includes in addition to the logger type and the serial number of the information data entered when programming the logger the date and the user ID of the user editing the data The data are shown as original data in the status field Reason for logging Date Username cfr cfr Name Signature Authorship cfr 20 01 2003 08 12 05 loffice Date Time __ rH C te ay 20 01 2003 08 07 40 44 2 21 2 2 I20 01 2003 08 07 43 44 1 21 2 3 20 01 2003 08 07 46 44 1 21 2 4 20 01 2003 08 07 49 44 1 21 2 5 20 01 2003 08 07 52 60 3 21 5 6 20 01 2003 08 07 22 5 Z 20 01 2003 08 07 23 3 8 20 01 2003 08 08 23 8 9 20 01 2003 08 08 04 89 0 22 8 10 20 01 2003 08 08 07 66 9 22 8 iE 20 01 2003 08 08 10 56 9 22 8 12 120 01 2003 08 08 13 50 5 22 8 13 20 01 2003 08 08 16 47 5 22 8 On selecting Save as the path to the saved file will be shown After the file has been signed the meaning of the signing the user ID and the time stamp of the signature with date and time are also shown Second signature Over time an electronic record can be provided repeatedly with an electronic signature the reason for the signature can change Seen and approved by Auth
51. ures password security and helps protect the system from harmful programs I Require users to press Ctrl Alt Delete before logging on OK Cancel Note You can purchase such certificates from authorised sources If a certificate has been stored on the computer a file can be digitally signed in the ComSoft application Note If under the security settings in the Comfort Software you have made a signature obligatory for saving files a certificate must be stored locally for the user s concerned 27 ComSoft access control 28 sata se oo A mG Individual rights for user groups An administrator or member of the ComSoft Admins local group can make individual functions or system possibilities available or not available to user groups previously set up in the operating system Testo Comfort Software CFR Fie Instrument Edt View Insert Format Toos window xf Filename 2 archive O Files POAhsndheld Sample tiles 3 testostor 71 508 1897 Bus connection After selecting Security Settings under e mail notification an e mail address can be entered to which a message is automatically sent if registration fails due to missing registration information x Procedure efertefed logn F send emai to Coa Jow Under Local Groups individual rights can be granted for the 3 user groups Admins Power User and User Under each group appears a list of indiv
52. ving and makes recommendations on how you can secure your position with regard to the FDA by means of additional SOPs The complete text of the regulation is available on the Internet at http www fda gov The following is only a short summary Part 11 electronic records and electronic signatures deals with the criteria for regarding electronic data records and signatures as equivalent to paper documents with handwritten signatures This covers data records that are created altered maintained archived and transmitted Such data records can be securely handled in so called closed systems i e in an environment to which only a controlled group of persons has access In the software this access control is implemented by the allocation of usernames and passwords and of special user rights giving or restricting access to various software functions The system used must be validated within its environment in order to ensure that precision reliability and fitness for purpose are as required Invalid or altered data records should be identified in good time either automatically or by suitable validation techniques and isolated Further measures described in paragraph 11 10 serve to protect established electronic data records against unauthorised access and modifications In addition to the actual data record so called audit trails are stored which contain all peripheral information since the start of the system or the creatio
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