Description
You will receive an overview of the validation procedure and will be able to assign all activities and documents carried out in the process. In addition, you will receive profound suggestions for an optimal procedure at various points and can thus avoid typical pitfalls.
The aim of the course is for each participant to have an overview of all activities in a computer system validation (CSV). This includes knowing the type of documentation and getting at least a first impression in the exercises. If participants have already had experience with parts of a validation, this knowledge can be integrated into the overall context.
Zielgruppe
Dieses Seminar richtet sich an:
Mitarbeitende als auch Leitungen von Bereichen, die mit der Validierung (CSV unter GxP) konfrontiert werden und nur geringe Erfahrungen damit haben.
(Grundkurs; gewisses Grundwissen ist Voraussetzung), Management, IT-Leitung, Projektleitung und Mitarbeitende in Validierungsprojekten (Ressourcen-optimierte Validierung)
Lernziele
Nach dem Seminar
– haben Sie einen Überblick über die Dokumentation bei einer Validierung von computerisierten Systemen erhalten.
– sind Ihnen die GAMP-5 Kategorien zur Validierung von Software bekannt und Sie können diese in Ihre Validierungsmodelle einbeziehen.
– wissen Sie, welche Informationen ein Lastenheft (User requirement specification – URS) beinhaltet und wie es aufgebaut ist.
– haben Sie die Chancen und Risiken einer CSV kennengelernt und wissen wie Sie diese über ein Risikomanagement bewerten.
Program
Day 1: 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 a possible malfunction, evaluates the resulting risk and describes suitable countermeasures.
Verification and system release
- The installation documentation must make the structure 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 user 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 manufacturer.
Involve 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 validation
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 prepares the entire second project phase before the middle of the project.
Systematically select, write and refine test cases
- Important work for system operation
You can find the program here.
