CS are becoming increasingly important, especially in the pharmaceutical industry, in order to meet the increasing demands on production. At the same time, their use must not compromise patient safety.
This brings with it increasing challenges in the scope of validation and qualification of the system: Proof that CS function properly and do not pose an increased risk to patients can only be provided by taking a holistic view of the system. A master plan is therefore a useful document for defining the scope of the project.
Complexity of the scope of validation
The initial classification of the CS into a software category according to GAMP 5 provides guidance on the complexity of the scope of validation:
- Operating systems
- N/A
- Non-configurable software (standard software)
- Configurable software
- Individual customer software
A risk assessment is now used to check the criticality of the CS with regard to GxP relevance, i.e. the extent to which there is an impact on patient safety. A detailed identification and analysis of risks and the definition of suitable control measures to minimize or completely exclude these risks is essential. A continuous review is also essential for a complete audit.
In addition to determining areas of application, exact specifications and their influence on patient safety, individually planned tests with suitable acceptance criteria are also included in the CS review.
The validation of the process then goes hand in hand with the qualification of the process environment, divided into the phases of design, installation, function and performance testing. This allows individual specifications to be checked and verified step by step.
Only once qualification and validation have been successfully completed and proof of suitability for the intended process has been provided can the CS be used without any increased risk to patient safety.
