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.
Target group
This 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 required), management, IT management, project management and employees in validation projects (resource-optimized validation)
Learning objectives
After the seminar
you will have gained an overview of the documentation required for the validation of computerized systems.
be familiar with the GAMP-5 categories for the validation of software and be able to include them in your validation models.
know what information a user requirement specification (URS) contains and how it is structured.
you have become familiar with the opportunities and risks of a CSV and know how to evaluate them using risk management.
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.
