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1 Am Ende drucken wir alles aus und unterschreiben auf Papier Hybride Lösungen und 21 CFR Part 11 Dr. Anne Kramer, sepp.med GmbH

2 Über sepp.med > 35 Jahre IT-Expertise Prozessberatung SW-Entwicklung QS & Test Schulung Komplexe und sicherheitskritische Systeme Selbstverständnis IT-Dienstleister Werkzeughersteller Methodenprovider Trainingsprovider Professional IT-Services 2

3 sepp.med Standorte 3

4 Wie managen Sie Ihre Anforderungen / Testfälle? So? Oder so? 4

5 21 CFR Part 11 goes online

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7 11.1(b) Scope This part applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations. This part also applies to electronic records submitted to the agency under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in agency regulations. However, this part does not apply to paper records that are, or have been, transmitted by electronic means. 7

Open system means an environment in which system access is not controlled by

8 Closed system means an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. Open system means an environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system. 8

9 Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature. Digital signature means an electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified. 9

10 Grundlegende Forderungen in 21 CFR 21 Schutz elektronischer Daten vor (böswilliger) Veränderung Rechtekonzept, Zugriffschutz 10

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Grundlegende Forderungen in 21 CFR 21 Schutz elektronischer Daten vor (böswilliger) Veränderung Rechtekonzept, Zugriffschutz bewusste, klar gekennzeichnete

12 Grundlegende Forderungen in 21 CFR 21 Schutz elektronischer Daten vor (böswilliger) Veränderung Rechtekonzept, Zugriffschutz bewusste, klar gekennzeichnete Unterschrift mit mindestens zwei Authentifizierungs-Komponenten Login und Passwort, Schulung Audit-Trails ausdruckbar, inkrementell (alte Einträge bleiben erhalten) 12

13 Am Ende drucken wir alles aus und unterschreiben auf Papier 13

14 Erläuterung in FDA-Guidance Records that are required to be maintained under predicate rule requirements and that are maintained in electronic format in place of paper format. Records that are required to be maintained under predicate rules, that are maintained in electronic format in addition to paper format, and that are relied on to perform regulated activities. FDA Guidance for Industry: Part 11, Electronic Records; Electronic Signatures Scope and Application 14

11.70 Signature / Record Linking Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective

15 11.70 Signature / Record Linking 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. 15

16 Wie stellen Sie sicher, dass dies hier mit dem hier identisch ist? 16

17 21 CFR Part 11 Compliance Checkliste 17

18 ausgefüllte Checklist (Beispiel) 18

19 Was aus 21 CFR 11 folgt Anforderungen an das Werkzeug Konfiguration und/oder Implementierung z.b. Schreibschutz für freigegebene Datensätze Anforderungen an den Prozess kontrollierter Zugriff auf das System IT-Richtlinien Backup/Restore-Konzept 19

20 Beispiel 1: Validierung ALM Tool 20

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23 Beispiel 2: Validierung Testtool (mit Abgrenzung) 23

24 Beispiel: Prozessbeschreibung act RequirementsEngineering Create and edit Requirement (Author) Draft Draft => Canceled idea rejected requirement ready for review Cancel Requirement (Author) Canceled Request Review of SRD (Author) Draft => Awaiting Review Review Requirement (Approver) Awaiting Review => Reviewed The review itself is performed using the SRD document. The requirements status disapproved by at least one reviewer approved by all reviewers related Tasks: Specification Task Prepare SRD review (Author) Reviewed => Approved related Documents & Reports: SRD Design Requirement Traceability Review_export SRD is printed and signed wet 24

25 Beispiel: Prozessbeschreibung (Zoom) 25

26 Beispiel: Testfall Test step Set Assignee to <name>. Set status to Awaiting Review. Expected result The SRD is listed in the task list of <name>. 26

To meet the demands of the life sciences industry, ( ) has been pre-validated ( ) and is offered with a 21 CFR Part

27 Warnung vor dem Hersteller The ability to effectively manage electronic records according to Federal regulations is provided. To meet the demands of the life sciences industry, ( ) has been pre-validated ( ) and is offered with a 21 CFR Part 11 compliant esignature workflow. Part 11 Section requires the linking of electronic (and handwritten) signatures to their corresponding electronic records. ( ) automatically links every signature to a specified record. 27

28 11.10 (e) Audit Trails 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. 28

29 Tipp: Meine persönliche Killerfrage Lässt sich der Audit-Trail ausdrucken? 29

30 Zusammenhang mit Security Bedrohungen Spoofing Tampering Repudiation Information disclosure Denial of service Elevation of privilege 21 CFR 11 ensure that the signatures cannot be excised, copied, to falsify an electronic record use of authority checks to ensure that only authorized individuals can use the system, protection of records to enable their accurate and ready retrieval throughout the records retention period 30

31 Vielen Dank für Ihre Aufmerksamkeit! Dr. Anne Kramer Tel:

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