Can I run a scenario by you as to my plan.
1. Create an overall master validation plan - then create my validation/qualification of equipment into a validation plan
2. Use a risk based approach to qualify the equipment that is already installed - does a high, medium, low risk level work?
3. List all equipment and assign the level to each
4. Since all the equipment is already installed I will IQ based on the equipment was installed per mfg spec, in the proper manner, and is placed in a suitable environment.
5. use the rationale that all end product produced is 100% QC per work instruction
6. Rationalize that the last 3 lots of the DHR were reviewed and no failures observed
7. write 1 final report stating the equipment was installed properly, and using 100% inspection, and the inspection of the last 3 lots showed no defects, and it is verified this way.
Anything else I should consider?
Thanks
1. Create an overall master validation plan - then create my validation/qualification of equipment into a validation plan
2. Use a risk based approach to qualify the equipment that is already installed - does a high, medium, low risk level work?
3. List all equipment and assign the level to each
4. Since all the equipment is already installed I will IQ based on the equipment was installed per mfg spec, in the proper manner, and is placed in a suitable environment.
5. use the rationale that all end product produced is 100% QC per work instruction
6. Rationalize that the last 3 lots of the DHR were reviewed and no failures observed
7. write 1 final report stating the equipment was installed properly, and using 100% inspection, and the inspection of the last 3 lots showed no defects, and it is verified this way.
Anything else I should consider?
Thanks