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Zeichen setzen für die Zukunft Committing to the future Market Launch Documentation Testo Saveris 21CFR11 Software July 2009.

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Presentation on theme: "Zeichen setzen für die Zukunft Committing to the future Market Launch Documentation Testo Saveris 21CFR11 Software July 2009."— Presentation transcript:

1 Zeichen setzen für die Zukunft Committing to the future Market Launch Documentation Testo Saveris 21CFR11 Software July 2009

2 2/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Table of Contents General information regarding CFR (slide 2-8) Target groups and applications (slide 9-12) Delivery/scope of services Saveris CFR Software (slide 13-16) Services (slide 17-21) Saveris CFR access and authorization concept (slide 22-27) Saveris CFR software features (slide 28-39) Data security with the Saveris system (slide 40-45) Advertising material (slide 46-47) System requirements (slide 49-50)

3 3/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Regulations for pharmaceutical production Due to this reason Testo developed the Saveris CFR software according to the following international directives: USA:21 CFR 11 of the FDA (Food and Drug Administration) Europe:Annex 11 of the EU-GMP-regulations The pharmaceutical industry has to meet strict regulatory requirements of pharmaceutical production.

4 4/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future 21CFR Part 11 of the FDA 21 CFR Part 11 is legally obligatory for all pharmaceutical enterprises that import to the US or produce drugs there, as well as their suppliers. Already in other countries approved, existing and obligatory as quality standard. Content Criteria check-list which has to be met, so that electronic records and electronic signatures are regarded equally to written documents and written signatures. Requirements Continuous recording and long-term data-backup of the readings under the following conditions: - Authenticity - Integrity - Confidentiality - Non-repudiation of the authorship of electronic signatures due to the inextricable connection with the electronic records. 21 CFR 11-directive in the Internet

5 5/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future GMP (Good Manufacturing Practice) Content - The GMP directives commit the pharmaceutical industry to hygienic, correct, traceably documented and strictly controlled pharmaceutical production. - The GMP directives represent general conditions for a good pharmaceutical production, however they do not include detailed proceeding instructions. - The WHO GMP directives are merely recommendations for achieving high quality standards in pharmaceutical production, which are not legally obligatory. Realization of the WHO GMP directives in national regulations - cGMP: current GMP GMP directives of the USA, published in the CFR - EU-GMP: GMP directives of the EU; not legally obligatory, but state of the art - AMWHV: Pharmaceutical and active ingredient production regulation realization of the EU-GMP directives in German law - PIC-GMP: GMP directives of a federation of national pharmaceutical monitoring surveillance authorities, not legally obligatory

6 6/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future testo Saveris CFR Software in the context of GAMP5 Continuing documentation around the software is getting more and more important – keyword GAMP 5 (=Good Automated Manufacturing Practice) as a guideline for the practice – - GAMP 5 is a European guideline for validation of computer based systems in GxP regulated areas (GxP includes GMP, GCP and GDP). - GAMP 5 is legally not obligatory, but it is a guideline. - A GAMP 5 conformance cannot be certified, as GAMP 5 does not represent a legal standard. - The focus is on patient safety, product quality and data integrity. - The supplier (here: Testo AG) is integrated in the process as far as possible and the qualification is controlled regularly by pharmaceutical enterprises.

7 7/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Documentation for meeting directives A monitoring system like testo Saveris intervenes quite deeper in the IT environment and in the processes of the customer than data loggers. Therefore besides postal audits on-site-audits will possibly be carried out at Testo AG in the future. We have to plan in more customer queries regarding documentations for meeting directives like 21 CFR 11 and the GAMP guideline. Contact persons for further queries: Testo AG Product Management & Quality Management Documentation regarding the following subjects are available on customer request: Process descriptions Abstract from development guidelines Certificates Change log Examples from test plans

8 8/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future The pharmaceutical industry as a customer Usually the contact person in the company is the department manager of quality management, production or development. For the pharmaceutical industry the price normally is less important, however here as well a certain price pressure starts. Pharmaceutical customers very exactly analyze the risks of a system before deciding for a monitoring system, therefore the presales phase will last proportionally long. When purchasing new Saveris probes for an already existing CFR system pharmaceutical customers reluctantly change to a new firmware version, as then potentially they could have to re-validate the whole system. Attention: If customers insist on purchasing probes with an old firmware version, the support by Testo customer service could be restricted.

9 9/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Table of Contents General information regarding CFR (slide 2-8) Target groups and applications (slide 9-12) Delivery/scope of services Saveris CFR Software (slide 13-16) Services (slide 17-21) Saveris CFR access and authorization concept (slide 22-27) Saveris CFR software features (slide 28-39) Data security with the Saveris system (slide 40-45) Advertising material (slide 46-47) System requirements (slide 49-50)

10 10/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Saveris CFR in Pharma Production, QA and Cleanrooms for constant production conditions in the pharmaceutical sector in heat sensitive processes during test runs as well as setups for quality assurance in production processes for monitoring temperature or climate data in comparison to set points Recording and documentation of temperature and/or humidity:

11 11/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Saveris CFR in laboratories and hospitals Temperature/humidity monitoring in freezers as well as refrigerators for storing drugs Recording and documentation of ambience values in storage rooms for storing drugs Temperature/humidity monitoring in blood banks

12 12/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Saveris CFR in R&D Processes Recording and documentation of temperature and/or humidity values in R&D processes. Testo Saveris enables constant climatic conditions in e.g. research facilities. Suitable for short-term as well as long- term measurements.

13 13/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Table of Contents General information regarding CFR (slide 2-8) Target groups and applications (slide 9-12) Delivery/scope of services Saveris CFR Software (slide 13-16) Services (slide 17-21) Saveris CFR access and authorization concept (slide 22-27) Saveris CFR software features (slide 28-39) Data security with the Saveris system (slide 40-45) Advertising material (slide 46-47) System requirements (slide 49-50)

14 14/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Saveris CFR Software: part no.: (incl. Ethernet cable instead of USB cable) Delivery/Scope of services Saveris CFR Software Certificate Saveris CFR Software incl. Instruction manual master for Risk analysis master for validation specifications master for validation masterplan Certificate Inspection document by independent Fraunhofer IESE Institute, that Saveris CFR meets the requirements according to 21 CFR Part 11. The test was carried out according to the evaluation guidelines of the GAMP Special Interest Group. Documentations which support validation: Validation masterplan Individually extendable master for validation masterplan based on GAMP5 Validation specifications Individually extendable master for validation specifications based on GAMP5 Risk analysis Individually extendable master for risk analysis based on GAMP5

15 15/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future 1 x server installation, any number of clients/viewer installations within a network (like Saveris PROF). Saveris Server with SQL-database Viewer (confirmation of alarms and view data) Client (configuration, confirmation of alarms and view data) Client Viewer Saveris CFR Software as multiple licence Saveris CFR can be used on several workstations (like Saveris Professional Software)

16 16/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Testo Saveris CFR TM Alarms and storage also without running PC Broad product range of Saveris probes for different applications Extensive validation- and qualification services by Testo Industrial Services Saveris CFR Software already is a multiple licence Combination of radio and Ethernet probes Import the adjustment history in Saveris CFR USP´s complete package Saveris CFR Certificate by external provider Fraunhofer IESE institute Documents which support validation are included in software package

17 17/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Table of Contents General information regarding CFR (slide 2-8) Target groups and applications (slide 9-12) Delivery/scope of services Saveris CFR Software (slide 13-16) Services (slide 17-21) Saveris CFR access and authorization concept (slide 22-27) Saveris CFR software features (slide 28-39) Data security with the Saveris system (slide 40-45) Advertising material (slide 46-47) System requirements (slide 49-50)

18 18/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Validation by TIS Monitoring systems are computer systems. Pharmaceutical enterprises – as GxP regulated enterprises - are instructed by the FDA and EU guidelines as well as completed by internal QA regulations, that they have to validate computer systems. Depending on the enterprise this has to be carried out according to GAMP or similar. System Validation Validation = Proof (on site) of the conformity (with the valid directives) as well as Proof of the aptitude for the targeted purpose … always considering the concrete conditions / instructions on site! A Saveris Validation-Standard- Package similar to datalogger / CFR will not be available.

19 19/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Everything from one hand Monitoring systems for the target group Pharma Request Everything from one hand! Minimizing the risk for the customer Minimizing time and costs for the customer System Commissioning (îf required) Validation System and commissioning (if required): service via Testo AG / Testo subsidiary / possibly external service provider Validation: service via Testo Industrial Services Customer specific validation of the Saveris CFR system will be carried out by TIS!

20 20/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Overview of TIS services for Saveris In the pharmaceutical industry calibration of measuring probes is very important. Therefore generally the probes first calibration should be offered in sales discussions. On re-calibration TIS provides the file with the adjustment data on customer request, for integration into the customer system. Should validation services be relevant, TIS employees should be integrated at an early stage (competent consultation, suitable offer = validation concept). TIS is going to offer Saveris validations WORLDWIDE; abroad probably not for small systems (< 10 probes). The validation costs per project vary strongly, depending on the size of the system, complexity as well as QA requirements of the customer. First Saveris validation concepts (offers) can probably be generated by TIS from October 2009 on; please send enquiries to Jens Amberg TIS offers will be directed to Testo subsidiaries/ representations, not directly to the final customer. After first market experience, TIS will publish a brochure regarding validation respectively regarding Services around testo Saveris.

21 21/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Overview of TIS services for Saveris Qualification concept for Saveris CFR Installation Qualification (IQ) = documented proof, that a system has been installed according to written and approved specifications. Design Qualification (DQ) = documented proof, that the recommended design (structure) of the system is suitable for the intended purpose. Operational Qualification (OQ) = documented proof, that a system is working within all specified operating areas according to written and approved specifications. Performance Qualification (PQ) = documented proof, that a system within its determined operating ambience is able to carry out or control activities of the actions for which it is designed for according to written and approved specifications. In the Saveris CFR brochure the TIS services for customer specific qualification and validation concepts are explicitely pointed out! Mapping For ideal probe positioning.

22 22/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Table of Contents General information regarding CFR (slide 2-8) Target groups and applications (slide 9-12) Delivery/scope of services Saveris CFR Software (slide 13-16) Services (slide 17-21) Saveris CFR access and authorization concept (slide 22-27) Saveris CFR software features (slide 28-39) Data security with the Saveris system (slide 40-45) Advertising material (slide 46-47) System requirements (slide 49-50)

23 23/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Complete integration of the access concept into the established Windows security system (certificates, authorization management, user and password management, user authentification). Authorization concept: allocation of authorizations in the Saveris CFR software by the IT-administrator for three user levels (user management: testo-ComSoft-Admin, testo- ComSoft-PowerUsers, testo-ComSoft-Users) =>Administrators work with established standard tools and do not need special user know-how. =>A special Testo security system would hardly be manageable, as the customer else would have to check the function and validation ability separately. Windows security = one consistent security system company-wide. Saveris CFR access and authorization concept IT-Admin Administrator Benutzer A

24 24/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Saveris CFR access concept Saveris CFR uses established Windows security system. Access to SQL database only by IT-administrator. Saveris CFR uses local groups (Testo-Comsoft-Admins, -PowerUsers, -Users). Only IT-Administrators or Testo group members can work with the system.

25 25/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Saveris CFR authorization concept IT-Administrator of the customer at first installs Saveris CFR and then assigns the users to the Testo groups. Assignment of the users to the 3 Testo groups is carried out either directly in the CFR software or via the computer management of the operating system. User accounts Testo-ComSoft-Admins Testo-ComSoft-Powerusers Testo-ComSoft-Users IT-Admin user A user B user C IT-Admin User groups in Saveris CFR

26 26/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Saveris CFR authorization concept Confirm alarm Change alarm settings Change settings in the system area (measuring cycle, battery type) Firmware update Import adjustment data Sign on / off components Create PDF report In the standard setting no user rights are assigned! Access to the different user rights of the Saveris Systems can specifically be assigned to the members of the Testo groups via the Testo-ComSoft-Admin.

27 27/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Saveris CFR authorization concept Commissioning Saveris CFR is carried out by the IT-administrator or testo-ComSoft- Admin (configurations in the start-up assistant only by IT-administrator or testo- ComSoft-Admin). In the later Saveris operation other groups as well (testo-ComSoft-PowerUser/testo- ComSoft-User) can work in the start-up assistant. Precondition: IT-administrator / testo-ComSoft-Admin assigns the authorizations to the appropriate groups (testo-ComSoft-PowerUser / testo-ComSoft-User). ActionExecution by: Saveris CFR InstallationIT-administrator of the customer Assignation of user accounts to Saveris groups (testo-ComSoft-Admin, -PowerUser, -User IT-administrator of the customer Saveris CFR commissioningIT-administrator of the customer or Testo- ComSoft-Admin Working in the Saveris SystemIT-administrator as well as all 3 Testo groups Summary:

28 28/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Table of Contents General information regarding CFR (slide 2-8) Target groups and applications (slide 9-12) Delivery/scope of services Saveris CFR Software (slide 13-16) Services (slide 17-21) Saveris CFR access and authorization concept (slide 22-27) Saveris CFR software features (slide 28-39) Data security with the Saveris system (slide 40-45) Advertising material (slide 46-47) System requirements (slide 49-50)

29 29/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future testo Saveris CFR Software – Features Recording the raw data in SQL database, which is in admin-regulated user access and therefore not freely accessible Generating non manipulable PDF reports (automatically as well as manually) Automatic or manual back-up of the measuring data Validation compliant software in network ambience. Idea of closed system is further on pursued and is guaranteed by admin-regulated user regulations as well as Testo own data protocols (proprietary) with radio and Ethernet Import of adjustment data as well as view of adjustment history Configuration of warning limits and main alarms Identification code (Hashcode) for clear allocation of e.g. PDF reports Audit trail for traceability of user activities in the Saveris system. CFR compliant data recording with check sum secured database to guarantee data security. Electronic signatures with reason of the signature Additionally new with Saveris CFR (in comparison to CFR ComSoft for data loggers)

30 30/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Back-up of Saveris data (1) Manual back-up Manual back-up of the measurement data in the database (cross-project). Back-up files can be imported into new project Archiving/ storage location of the back-up files lies within the responsibility of the customer. Due to safety reasons the back-up files should be stored on a different PC than the Saveris database Select target directory and name file Target directory for back-up files has to be activated for network services. Otherwise a back-up of the data is not possible! button for manual back-up 1.2.

31 31/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Back-up of Saveris data (2) Automatic back-up Automatic daily back-up of the measurement data in the database (cross-project). Back-up files can be imported into new project Archiving/ storage location of the back-up files lies within the responsibility of the customer. Due to safety reasons the back-up files should be stored on a different PC than the Saveris database select target directory Target directory for back-up files has to be activated for network services. Otherwise a back-up of the data is not possible! Button for automatic back-up 1.2.

32 32/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future PDF report generation (1) Automatic PDF report generation Automatic PDF report generation on the server. Each report includes a data summary of one zone. Can be individually configured by the user (report generation daily, weekly or monthly possible). Content of the PDF report can be configured for each zone individually (table, graph, alarms). Can be archived as a PDF in a folder or sent via .

33 33/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future PDF report generation (2) Identification code (Hashcode) of the PDF report 21 CFR 11 compliant printouts Can be recorded as PDF with master password (is configured in the security settings by an authorized user). The PDF report includes: CFR compliant cover page Graph, table of measured data and alarms of selected zone Audit trail Manual PDF report generation (create report file) of the specified time period in the calendar

34 34/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Audit Trail (1) System start up Time synced Log start set Probe cycle set Channel name set Channel upper/lower limit set Signed Alarm confirmed Alarm settings changed Probe settings changed Alarm recipient changed Alarm route changed Certificate has been imported Probe has been removed Probe has been added System has been stopped Firmware update Router configuration Channel upper/lower warning limit set Alarm group has been removed In the Audit Trail the following events are recorded: Audit trail for documentation/ traceability of the user activities via the signed on/ authorized user.

35 35/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Audit Trail (2) Index (serial Audit-trail-number) Date/time (When was there a change in the system?) User (Who carried out the change?) Action (What has been done/changed?) Instrument (specification of the serial number and the channel of the Saveris component concerned) Details (Are there any further details regarding the change / event) Reference The following information regarding the events on slide 34 is available in the audit trail : Audit Trail can be filtered according to categories as well exported and printed as HTML-file Precondition for export and print: HTML supporting browser Filter function

36 36/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Electronic signatures Electronic signatures with specification of the reason of the signature, e.g. when changing configurations. Is displayed in the Audit Trail. For the following user activities an electronic signature can be obliged : confirm alarm change alarm settings change settings in the menu system log on or log off components generate PDF report

37 37/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Adjustment data can be imported into SQL database and therefore into CFR software During adjustment: one adjustment file per probe will be generated The adjustment file is named according to the serial number of the probe (e.g ) Saveris _1 °C 26.0°C26.3°C Import adjustment data

38 38/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Operating sequence of the adjustement process Offset between reference value and actual probe value is conducted Data are written into the probe, NOT into the Saveris database directly! 123 Adjustment data files File is created on adjustment PC where adjustment data are saved 4 Documents and settings\common documents\saveris adjustment software 5 Click on Import Button in CFR software (menu point system) 6 Adjustment history is now available in Saveris database SQL Adjustment data file must be copied onto Saveris Server PC

39 39/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future testo Saveris CFR Software – Features Update Saveris Software Update from Saveris PROF to Saveris CFR is possible (not from SBE to CFR). With the update from Saveris PROF to Saveris CFR the feature Audit Trail is not available for running projects Therefore: After an update active projects should be finished and new projects should be generated. This guarantees that all functions of the CFR Software are available. Data view via Internet (Web access), order-no at present not CFR compliant.

40 40/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Table of Contents General information regarding CFR (slide 2-8) Target groups and applications (slide 9-12) Delivery/scope of services Saveris CFR Software (slide 13-16) Services (slide 17-21) Saveris CFR access and authorization concept (slide 22-27) Saveris CFR software features (slide 28-39) Data security with the Saveris system (slide 40-45) Advertising material (slide 46-47) System requirements (slide 49-50)

41 41/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Data security Saveris - general Redundant recording of the data in: Saveris radio/Ethernet probes (6.000 readings) Saveris Base ( readings per channel) Saveris database (4 Gigabyte) Battery operated radio probes (battery lifetime approx. 3 years with a measuring cycle of 15 min. and +25°C) Emergency battery in the testo Saveris Base as well as in the Ethernet probes Alarm not only in case of limit value exceeded but as well in case of low battery, disturbed radio transmission and power failure Recording and alarm as well without running PC. Bi-directional radio transmission Testo own transmission protocol with radio and Ethernet (proprietory)

42 42/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Data security Saveris Base – database Redundant recording of the alarm protocols in Base and database Automatic daily back-up of the database files can be set Manual back-up of the database files at any time Back-up of the database can as well be carried out with standard back-up software (e.g. Microsoft Management Studio Express, Robocop, Dataprotector) Sa access to the SQL database with public password (like in SBE/PROF) does not exist => better protection against database manipulation Synchronisation services work with secret database account

43 43/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Data security Saveris radio probes – Saveris Base 1. Base, are you active? 3. Can I send data package? 5. I am sending the data package. 7. OK. May I delete the data package? 2. Yes. 4. Yes, send data package. 6. I received the data package. 8. Yes, you may delete the data package. Data package is sent every 15 minutes Standard frequency with Testo own protocol (proprietory) Via the bi-directional radio transmission Base and probe communicate in a dialogue instead of monologue (readings are only deleted in the probe after they were received safely in the Base). During radio transmission Saveris saves the data in a Testo own protocol => the data cannot be read by other radio systems respectively the data cannot be influenced/ received by other systems.

44 44/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Data security Saveris Ethernet probes – Saveris Base Data transmission every minute Network protocol TCP/IP Transfer protocol HTTP with Testo own protocol (proprietory) Via the transmission Base and probe communicate in dialogue instead of monologue. During transmission Saveris protects the data with a Testo own protocol for unintentional access. 1. Base, are you active? 3. Can I send data package? 5. I am sending the data package. 7. OK. May I delete the data package? 2. Yes. 4. Yes, send data package. 6. I received the data package. 8. Yes, you may delete the data package. Port 80

45 45/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future System-related risks Traceability of adjustments => adjustment of probes can only be retraced if adjustment data for the appropriate probe are manually imported into the Saveris software. Upgrade installation: running non-CFR-projects cannot be CFR-sealed afterwards. Therefore after update to CFR: start new project! Maintenance works: renaming server computers. Changes in the user administration (e.g. deleting created user groups). Power failure on PC with SQL Server. Loss of the PC with the database and the recorded data back-up. Administrators or testo-ComSoft-admins could get access to the data tables on the database level and change them (criminal intent).

46 46/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Table of Contents General information regarding CFR (slide 2-8) Target groups and applications (slide 9-12) Delivery/scope of services Saveris CFR Software (slide13-16) Services (slide 17-21) Saveris CFR access and authorization concept (slide 22-27) Saveris CFR software features (slide 28-39) Data security with the Saveris system (slide 40-45) Advertising material (slide 46-47) System requirements (slide 49-50)

47 47/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Advertising material Saveris CFR brochure Advertisement Mailing/ ing Press information

48 48/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Table of Contents General information regarding CFR (slide 2-8) Target groups and applications (slide 9-12) Delivery/scope of services Saveris CFR Software (slide13-16) Services (slide 17-21) Saveris CFR access and authorization concept (slide 22-27) Saveris CFR software features (slide 28-39) Data security with the Saveris system (slide 40-45) Advertising material (slide 46-47) System requirements (slide 49-50)

49 49/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Installation requirements (1) Hardware-requirements Pentium III compatible or higher (1 GHz oder higher is recommended) Minimum 512 MB working memory Hard drive: 4,35 GB => 350 MB for complete installation of MS SQL Server 2005 Express => 4 GB for data supported by SQL Server Express (additional log file) Drive: CD-ROM- or DVD-ROM-drive Display: Monitor with super VGA-resolution (1.024x768) or better Possible operating systems The software is running on the following 32-Bit operating systems: Windows 2000 Professional SP4 or higher Windows XP Home Edition SP2 or higher Windows XP Professional SP2 or higher for SP3: confirm the corresponding error message with OK. Windows Vista SP1 or higher (from Business version is recommended) Windows Server 2003 Enterprise Edition SP1 or higher (in case of installation on a server)

50 50/59 testo AG,Saveris CFR Software | wos/sed | July 09 Committing to the future Installation requirements (2) Additional system requirements for CFR Enough space and CPU performance for Microsoft SQL Server Central user administration over NT domain No further database (Exclusion: Microsoft SQL Server 2005 or upgrade version) Recommendation: no virus scanners on operating system (because of database efficiency) Recommendation: no firewall or special settings for Client operation Operation is preferred in closed company network Connection PC to Base only with Ethernet Microsoft Internet Explorer 6.0 SP1 or higher (if compatible) Microsoft Windows Installer 3.1 or higher MDAC 2.8 SP 1 or higher (this is only relevant if an SQL database is already operated on the same computer).Net Framework 2.0 Software requirements


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