Termin: 17. – 18.03.2026
Online
In diesem Seminar erhalten Sie einen Überblick über die Vorgehensweise bei der Validierung und können alle dabei durchgeführten Aktivitäten und Dokumente zuordnen. Zudem erhalten Sie an verschiedenen Stellen profunde Vorschläge für eine optimale Vorgehensweise und können damit typische Fallstricke umgehen. Das Ziel des Kurses ist, dass jeder Teilnehmende einen Überblick über alle Aktivitäten in einer Computer-System-Validierung (CSV) kennengelernt hat. Dazu gehört, die Art der Dokumentation zu kennen und in den Übungen zumindest einen ersten Eindruck bekommen zu haben. Wenn Teilnehmende bereits Erfahrungen mit Teilen einer Validierung gemacht haben, so lässt sich dieses Wissen einbinden in den gesamten Kontext.
Conditions of participation:
All information on reservations, booking, event documents and certificates of participation can be found in our conditions of participation for open events.
Target group
The seminar is aimed at
Employees as well as managers of departments who are confronted with validation (CSV under GxP) and have only limited experience with it (basic course; some basic knowledge is a prerequisite), management, IT management, project management and employees in validation projects (resource-optimized validation)
Validation of computerized systems
Validation planning and specification
- The validation plan describes the planned procedure, scope and responsibilities.
- The user requirements should form the basis of the planned functionality, but there are considerable differences here from project to project, which are shown in examples.
- The technical documentation consists of the functional specification, the system design and the configuration. Where available, information from the manufacturing company is included.
- The risk analysis as a central element of a CSV analyzes possible misconduct, assesses the resulting risk and describes suitable countermeasures.
Verification and system release
- The installation documentation must make the setup and configuration of the system reproducible.
- A three-stage procedure is presented for the test cases (function and user acceptance tests), which allows the test cases to be described at a very early stage.
- Formal criteria must be met for test execution and documentation. The validation report can be written based on successful tests.
Day 2: Resource-optimized validation
Optimization of the specification phase
- The usage requirements as the basis for the planned functionality must be structured, but should not get lost in detail.
- The technical documentation must have a clear structure and incorporate documents supplied by the manufacturing company.
Involving users in prototyping
- Involving the people who will later use the CSV is a great strength of agile and iterative projects and increases the chances of success and acceptance.
- It is shown how these methods are integrated into the validation process
Use risk analysis
- The risk analysis is the central element of every CSV and should be used to derive the test scope and test logic at a very early stage.
- This means that the entire second project phase will be prepared before the middle of the project.
Systematically select, write and refine test cases
Important work for system operation
Hier anmelden
Termin:
17. – 18. März 2026
Teilnahmegebühr: 1.170,00 € (1.392,30 € inkl. MwSt.)
Online
Contact
Dr. Klinkner & Partner GmbH
Wilhelm-Heinrich-Straße 16
66117 Saarbrücken
Tel +49 (0) 681 / 982 10 - 0
Web: http://www.klinkner.de