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