The first control discussed in Part 11.10 is that of computer system validation or in short CSV.
This control is one of the most important in a good manufacturing practices (GMP) environment.
The objective of the CSV process, 11.10(a), is to ensure the:
- Accuracy
- Reliability
- Consistency
- Intended performance of a computer system
- The integrity of the e-records
CSV is an element of the overall system development life cycle and is one of the most auditable aspects of the entire process.
In addition to the typical testing of the hardware and software, verification activities may include code walkthroughs, dynamic analysis and trace analysis.
Overall Process
The overall CSV process must take the following four criteria into account:
1. Will the system be able to meet the required regulatory standards laid down by 21 CFR Part 11?
2. The impact those systems might have on the:
- Accuracy
- Reliability
- Integrity
- Availability
- Authenticity of the required records and signatures
3. That a robust risk analysis is carried out to ensure the highest risk aspects of the systems are tested adequately.
4. And could the system potentially affect product quality or patient safety.
