The overall CSV process must take the following four criteria into account:
1. Regulatory Requirements
Will the system be able to meet the required regulatory standards laid down by 21 CFR Part 11?
2. Impact
The impact those systems might have on the:
- Accuracy
- Reliability
- Integrity
- Availability
- Authenticity of the required records and signatures
3. Risk Analysis
That a robust risk analysis is carried out to ensure the highest risk aspects of the systems are tested adequately.
4. Product & Patient Safety
And could the system potentially affect product quality or patient safety