SAUTER novapro Open Anwendung Pharma

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1 SAUTER novapro Open Anwendung Pharma

2 Inhalt 1. FDA Validierung 2. Authentifizierung 2.1 Active Directory Support 2.2 Architektur 2.3 Smart Card 2.4 Biometrie 2.5 Mehrstufige Authentifizierung 2.6 Web etoken 3. FDA Validierung 4. Profilerstellung 5. Audit Trail 6. Berichte 2

3 1. Validierung FDA 11.10(a) 11.10(b) 11.10(c) Anforderungen Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. Persons should contact the agency if there are any questions regarding the ability of the agency to perform such review and copying of the electronic records. Protection of records to enable their accurate and ready retrieval throughout the records retention period. Unsere Lösung mit novapro Open YES Native in the application YES Possibility to generate report, to define database connection, and alarms if the connections are broken YES Protection process validated true password 11.10(d) Limiting system access to authorized individuals YES Using groups, users and login strategy Using biometrical access control Station restriction ( scalable system restriction per user / per group per station ) (e) Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying. YES Audit trail functionality is native Data are stored in a database protected through password 11.10(f) Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate (g) Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand. YES Combination of audit trail and active security 11.10(h) Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction NA 11.10(k) Use of appropriate controls over systems documentation including: (1) Adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance. (2) Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation. NA Project documentation 3

4 1. Validierung FDA Anforderungen Signed electronic records shall contain information associated with the signing that clearly indicates all of the following: (1) The printed name of the signer; (2) The date and time when the signature was executed; and (3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature. The items identified in paragraphs (a)(1), (a)(2), and (a)(3) of this section shall be subject to the same controls as for electronic records and shall be included as part of any human readable form of the electronic record (such as electronic display or printout). Unsere Lösung mit novapro Open YES for Audit trail Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means. YES Signatures are unique and secure by encrypted password 4

5 1. Validierung FDA (a) (a)( 1) (a)( 1)(i) (a)( 1)(ii) (a)( 3) (a) (b) (d) Anforderung Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else. Electronic signatures that are not based upon biometrics shall: Employ at least two distinct identification components such as an identification code and password. When an individual executes a series of signings during a single, continuous period of controlled system access, the first signing shall be executed using all electronic signature components; subsequent signings shall be executed using at least one electronic signature component that is only executable by, and designed to be used only by, the individual. When an individual executes one or more signings not performed during a single, continuous period of controlled system access, each signing shall be executed using all of the electronic signature components. Be administered and executed to ensure that attempted use of an individual`s electronic signature by anyone other than its genuine owner requires collaboration of two or more individuals. (a) Maintaining the uniqueness of each combined identification code and password, such that no two individuals have the same combination of identification code and password. Ensuring that identification code and password issuances are periodically checked, recalled, or revised (e.g., to cover such events as password aging). (d) Use of transaction safeguards to prevent unauthorized use of passwords and/or identification codes, and to detect and report in an immediate and urgent manner any attempts at their unauthorized use to the system security unit, and, as appropriate, to organizational management. Unsere Lösung mit novapro Open YES Couple signature password are unique YES Couple signature password are unique YES After logon the same signature is used Auto log off is possible YES Auto logoff must be set then logon is required YES YES With historical password YES Mail can be send, System wide alarm, entry in alarm history 5

6 1. Validierung FDA (b) Anforderung The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. Persons should contact the agency if there are any questions regarding the ability of the agency to perform such review and copying of the electronic records. Unsere Lösung Possibility to generate report, to define database connection, and alarms if the connections are broken 6

7 1. Validierung FDA (c) Anforderung Protection of records to enable their accurate and ready retrieval throughout the records retention period. Unsere Lösung Protection process validated true password 7

8 1. Validierung FDA (d) Anforderung Limiting system access to authorized individuals Unsere Lösung Using groups, users and login strategy Using biometrical access control 8

9 1. Validierung FDA (e) Anforderung Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying. Unsere Lösung Audit trail functionality is native Data are stored in a database protected through password 9

10 1. Validierung FDA (g) Anforderung Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand. Unsere Lösung Combination of audit trail an active security 10

11 1. Validierung FDA Anforderung Signed electronic records shall contain information associated with the signing that clearly indicates all of the following: (1) The printed name of the signer; (2) The date and time when the signature was executed; and (3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature. The items identified in paragraphs (a)(1), (a)(2), and (a)(3) of this section shall be subject to the same controls as for electronic records and shall be included as part of any human readable form of the electronic record (such as electronic display or printout). Unsere Lösung Protection process validated true password 11

12 1. Validierung FDA A Anforderung Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means. Unsere Lösung Signature are unique and secure by encrypted password 12

13 2. Authentifizierung 2.1 Active Directory Support Architektur Domain Server novapro Open PDM Station für den Import der Benutzerdaten User Import Zentrale Benutzerverwaltung zur Verteilung der Benutzerdaten Für die Authentifizierung greifen die Client Stations direkt auf das Active Directory zu LDAP User Login User Import Central UM Standard Login *FDA:

14 2. Authentifizierung 2.1 Active Directory Support Integrierte Unterstützung von Active Directory Start des Import Tool Domain und DC Adresse eingeben Authentifizierung *FDA:

15 2. Authentifizierung 2.1 Active Directory Support Auswahl von Benutzer und Gruppen Die Active Directory Datenstruktur ist flach und korrespondiert mit der novapro Open Benutzerverwaltung ohne Datenverluste Eine Auswahl an Benutzer und Gruppen sind bereits hinterlegt *FDA:

16 2. Authentifizierung 2.2 Architektur Domain Server Domain Server Smartcard User Identification User Import novapro Open Server novapro Open Server LDAP User Login User Import Biometric Enrollment Central UM Biometric Login Standard Login Finger Print pattern *FDA:

17 2. Authenfizierung 2.3 Smart Card Domain Server Architektur Smartcard User Identification User Import novapro Open Server Active Directory = Authentifizierung der User Trusted Certificate = Registrierung der User LDAP User Login User Import Central UM Central UM = Austausch der Benutzerinformationen innerhalb des Netzwerks Standard Login *FDA:

18 2. Authenfizierung 2.3 Smart Card Import Domain Smart Card Users Einlegung der Smart Card zur Anmeldung *FDA:

19 2. Authentifizierung 2.4 Biometrie Authentifizierung mit dem Fingerabdruck Eine novapro Open Station ist für die Authentifizierung verantwortlich. novapro Open PDM Verteilung der biometrischen Daten im Netzwerk über die zentrale Benutzerverwaltung Central UM Biometric Enrollment Biometric Login Fingerprint Pattern *FDA:

20 2. Authentifizierung 2.4 Biometrie 1 zu 1 = Bestätigungsprozess Benutzernamen und Passwort eingeben Auswertung der Benutzeranmeldung mit dem Fingerabdruck- als zusätzliche Kontrolle 1 zu vielen = Identifikationsprozess Identifizierung des Benutzers durch seinen Fingerabdruck novapro Open sucht das entsprechende Benutzerkonto *FDA:

21 2. Authentifizierung 2.5 Mehrstufige Authentifizierung Highest Security 3-stufige Authentifizierung 7. Biometry 1:1 + User/Password + etoken with LDAP (3-factor) 2-stufige Authentifizierung 6. Biometry 1:1 + User/Password with LDAP (2-factor) 5. Biometry 1:1 + User/Password (2-factor) 4. etoken mit LDAP (2-fatctor) Lowest Security *FDA: stufige Authentifizierung 3. Biometry 1:N (1-factor) 2. User/Password mit LDAP (1-factor) 1. User/Password (1-factor) 21

22 2. Authentifizierung 2.6 Web etoken Authentifizierung über das Web SSL basierende Authentifizierung Three party handshake Privater LDAP Zugang Private/Public key encryption 22

23 2. Authentifizierung 2.6 Web etoken Architektur Authentification Service Key pair Web Client novapro Open *FDA:

24 2. Authentifizierung 2.6 Web etoken Anmeldung über Web etoken Erstellen Sie ein Web-User Zertifikat Bei der Anmeldung ist die SmartCard Authentifizierung zu wählen 24

25 3. Validierung FDA A Anforderung When an individual executes a series of signings during a single, continuous period of controlled system access, the first signing shall be executed using all electronic signature components; subsequent signings shall be executed using at least one electronic signature component that is only executable by, and designed to be used only by, the individual Unsere Lösung After logon the same signature is used Auto log off is possible 25

26 3. Validierung FDA B Anforderung Ensuring that identification code and password issuances are periodically checked, recalled, or revised (e.g., to cover such events as password aging). Unsere Lösung Historical password 26

27 3. Validierung FDA (d) Anforderung Use of transaction safeguards to prevent unauthorized use of passwords and/or identification codes, and to detect and report in an immediate and urgent manner any attempts at their unauthorized use to the system security unit, and, as appropriate, to organizational management. Unsere Lösung Mail can be send 27

28 4. Profil-Erstellung 28

29 5. Audit Trail 1. Aktivierung der Audit Trail Funktionalität 29

30 5. Audit Trail Datenbank Protokollierung der Bedieneraktionen über eine ODBC- Datenquelle in einer Datenbank Mögliche Datenbanken Access MS-SQL Oracle 30

31 5. Audit Trail Es wird ein Approval und ein HTML template benötigt 31

32 5. Audit Trail SAUTER erstellt einen Audit Trail mit: Datum Approval Template 32

33 6. Berichte Administrativ Datei Benutzer Aktion 33

34 SAUTER novapro Open Krankenhäuser

35 Krankenhäuser In Krankenhäusern ist die Reaktion des Wartungsteams entscheidend novapro Open bietet verschiedene Lösungen um ein schnelles Handeln zu ermöglichen 35

36 Inhalt 1. Alarm-Management 1.1 Konfiguration der Ereignisfenster 1.2 Konfiguration der Popups 1.3 Makros 1.4 Drucker 1.5 Definition von Alarmobjekten 1.6 Advanced Alarm Manager 1.7 Support mit Mobile Clients 36

37 1. Alarm-Management Alarme können in einem Ereignisfenster oder in speziellen Popups angezeigt werden 37

38 1. Alarm-Management Einfache Alarmdefinition mit Hilfe des Application Studios 38

39 1. Alarm-Management 1.1 Konfiguration der Ereignisfenster 39

40 1. Alarm-Management 1.2 Konfiguration der Popups Einstellbarer Ton 40

41 1. Alarm-Management 1.3 Makros Definition von Aktionen (Makros), die bei Auftreten eines Alarms durchgeführt werden Aktion kann in verschiedene Stadien des Alarms erfolgen Beginn Bestätigung Beendigung 41

42 1. Alarm-Management 1.3 Makros novapro Open bietet hierfür bereits vordefinierte Makros (Aktionen) 42

43 1. Alarm-Management 1.4 Drucker Alarmmeldungen werden an einen vordefinierten Drucker gesendet 43

44 1. Alarm-Management 1.5 Definition von Alarmobjekten 44

45 1. Alarm-Management 1.6 Advanced Alarm Manager AAM Versendung der Alarmmeldungen über SMS, , Pager, Voic Konfiguration erfolgt mit Hilfe eines Wizard 45

46 1. Alarm-Management 1.6 Advanced Alarm Manager AAM Benutzer definieren Zuweisung eines Alarms zu einer Gruppe 46

47 1. Alarm-Management 1.6 Advanced Alarm Manager AAM Advanced Alarm Viewer Anzeige detaillierter Informationen zu allen AAM-Alarmen Statistische Übersicht über AAM-Alarme Anzahl generierter Alarme Anzahl bearbeiteter Alarme 47

48 1. Alarm-Management 1.7 Support mit Mobile Clients Zugriff auf die Anlage via Mobile Clients Funktionsumfang für Mobile Clients nahezu identisch wie über den Web- Browser Internet Funktionen Ansicht von Bildern Wert-Änderung (Sollwerte) Zugriff auf Alarmlisten Trendberichte Dynamische Skalierung der Bildschirmgrösse novapro Open 48

49 1. Alarm-Management 1.7 Support mit Mobile Clients 1. Thin Client Application Packer Am Computer werden die Komponenten der Applikation ausgewählt und auf das Mobile Client geladen. Bilder Trend Alarmlisten 2. Thin-client Application Runtime Auswahl der gewünschten Applikation auf dem Mobile Client Die Ansicht setzt sich aus 2 Bereichen zusammen: 1.Oben: Hauptbereich 2.Unten: Navigation 49

50 1. Alarm-Management 1.7 Support mit Mobile Clients Anwendungsbeispiele Alarmliste Quittierung von Alarmen Trendansicht 51

51 1. Alarm-Management 1.7 Support mit Mobile Clients System Anforderungen OS: Mobile Platform mit JVM 1.3 oder höher, z.b. Windows CE oder Mobile (mit ELUTIONS Mobility Kit installer), oder Linux (Standard Sun JVM) Software: Nicht notwendig Optional: Web Browser zur Anzeige von HTML-Dateien PDF Reader zur Anzeige von PDF-Dateien Hardware: HDD: 5 MB Speicherplatz RAM: 64 MB Speicherplatz Touch-Bildschirm empfohlen 52