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Market Launch Documentation Testo Saveris 21CFR11 Software July 2009

Market Launch Documentation Testo Saveris 21CFR11 Software July 2009. 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)

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Market Launch Documentation Testo Saveris 21CFR11 Software July 2009

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  1. Market Launch DocumentationTesto Saveris 21CFR11 SoftwareJuly 2009

  2. 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. Regulations for pharmaceutical production The pharmaceutical industry has to meet strict regulatory requirements of 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

  4. 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“. • ContentCriteria check-list which has to be met, so that electronic records and electronic signatures are regarded equally to written documents and written signatures. • RequirementsContinuous 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. 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. 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. 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. 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. 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. Saveris CFR in Pharma Production, QA and Cleanrooms Recording and documentation of temperature and/or humidity: • 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

  11. 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. 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. 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. Delivery/Scope of services Saveris CFR Software CertificateInspection 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 masterplanIndividually extendable master for validation masterplan based on GAMP5 Validation specificationsIndividually extendable master for validation specifications based on GAMP5 Risk analysisIndividually extendable master for risk analysis based on GAMP5 Certificate Saveris CFR Software incl. Instruction manual master for Risk analysis master for validation masterplan master for validation specifications Saveris CFR Software: part no.: 0572 0182(incl. Ethernet cable instead of USB cable)

  15. Saveris CFR Software as multiple licence Saveris CFR can be used on several workstations (like Saveris Professional Software) Viewer Client Client (configuration, confirmation of alarms and view data) Saveris Server with SQL-database Client Viewer(confirmation of alarms and view data) Viewer 1 x server installation, any number of clients/viewer installations within a network (like Saveris PROF).

  16. Testo Saveris CFRTM USP´s complete package Saveris CFR Alarms and storage also without running PC Broad product range of Saveris probes for different applications Certificate by external provider Fraunhofer IESE institute Saveris CFR Software already is a multiple licence Documents which support validation are included in software package Combination of radio and Ethernet probes Import the adjustment history in Saveris CFR Extensive validation- and qualification services by Testo Industrial Services

  17. 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. Validation System 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 tovalidatecomputer systems. Depending on the enterprise this has to be carried out according to GAMP or similar. • 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. 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 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! Commissioning (îf required) System

  20. Overview of TIS services for Saveris • In the pharmaceutical industry calibration of measuring probes is very important. Therefore generally the probes‘ first calibrationshould 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 (jamberg@testo.de). 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. 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. Mapping For ideal probe positioning. In the Saveris CFR brochure the TIS services for customer specific qualification and validation concepts are explicitely pointed out!

  22. 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. IT-AdminAdministrator Benutzer A Saveris CFR access and authorization concept • 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.

  24. 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. Saveris CFR authorization concept IT-Administrator of the customer at first installs Saveris CFR and then assigns the users to the Testo groups. User accounts User groups in Saveris CFR IT-Admin user A user B user C Testo-ComSoft-Admins Testo-ComSoft-Powerusers Testo-ComSoft-Users IT-Admin 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.

  26. Saveris CFR authorization concept 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. • 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!

  27. 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). Summary:

  28. 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. testo Saveris CFR Software – Features • 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) • 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

  30. 1. 2. Back-up of Saveris data (1) button for manual back-up • 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!

  31. 1. 2. Back-up of Saveris data (2) Button for automatic back-up • 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!

  32. 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 email.

  33. PDF report generation (2) Manual PDF report generation („create report file“) • 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 of the specified time periodin the calendar

  34. Audit Trail (1) Audit trail for documentation/ traceability of the user activities via the signed on/ authorized user. In the Audit Trail the following events are recorded: • 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 • 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

  35. Audit Trail (2) The following information regarding the events on slide 34 is available in the audit trail : • 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 Filter function Audit Trail can be filtered according to categories as well exported and printed as HTML-file Precondition for export and print: HTML supporting browser

  36. 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. Import adjustment data 10.07.2009 25.05.2010 Saveris 1526334_1 °C 26.0°C 26.3°C • 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. 1526334)

  38. Operating sequence of the adjustement process 1 2 3 Adjustment data files Offset between reference value and actual probe value is conducted Data are written into the probe, NOT into the Saveris database directly! File is created on adjustment PC where adjustment data are saved Documents and settings\common documents\saveris adjustment software 4 5 Click on “Import” Button in CFR software (menu point “system”) 6 Adjustment data file must be copied onto Saveris Server PC SQL Adjustment history is now available in Saveris database

  39. 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. 0572 0184 at present not CFR compliant.

  40. 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. Data security Saveris - general • Redundant recording of the data in:► Saveris radio/Ethernet probes (6.000 readings)► Saveris Base (40.000 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. 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. Data security Saveris radio probes – Saveris Base Data package is sent every 15 minutes Standard frequency with Testo own protocol (proprietory) 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. • 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. Data security Saveris Ethernet probes – Saveris Base Data transmission every minute Network protocol TCP/IPTransfer protocol HTTP with Testo own protocol (proprietory) Port 80 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. • 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.

  45. 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. 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. Advertising material Mailing/ E-Mailing Saveris CFR brochure Advertisement Press information

  48. 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. 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. Installation requirements (2) Software requirements • 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 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

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