- The system must be validated.
- The system must be able to generate accurate, complete copies of data.
- Data records must be protected.
- System access must be restricted.
- Audit trails must be applied to all data.
- Operating system protection methods should be used where possible.
- Authorization checks must be applied.
- Data input/collection verification must be applied.
- Users must be trained.
- Standard Operating Procedures (SOPs) for the use of the system must be in place.
- Documents must be controlled.
- Change control must be applied.
Here are some simple methods to make the above process easier and to ensure that a system will pass a validation:.
- Ensure that all transducers, particle counters, and other devices are suitable for the purpose and have valid calibration certificates.
- Do not use complex data collection devices such as programmable logic controllers (PLCs) if they are not required. If a PLC is used, it will have a program, and additional validation will be required.
- When designing a system, consider how things can be tested and how documented evidence can be generated.
- Consider 21 CFR, Part 11 requirements and how these will be fulfilled.
- Use qualified people and reputable suppliers.
- Follow the steps listed within this V-model diagram.
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