PODCAST RELEASE
Why should you validate your Quality Management System Software when you work in the Medical Device Field?
Now let's review together the below situation and let me know if this happened to you:
- Auditor: Do you use software to manage your Quality system?
- You: Yes, I use an eQMS?
- Auditor: Do you have a validation report for this software?
- You: But I buy it as is so I am not the manufacturer of it.
- Auditor: Ok, then you don’t have a validation report?
- You: No!!!
- Auditor: Ok, then this is an observation
In this episode with Christophe Girardey from WEGA we will review what is expected from you regarding the validation of such software
Easy Medical Device
PODCAST RELEASE
Why should you validate your Quality Management System Software when you work in the Medical Device Field?
Now let's review together the below situation and let me know if this happened to you:
- Auditor: Do you use software to manage your Quality system?
- You: Yes, I use an eQMS?
- Auditor: Do you have a validation report for this software?
- You: But I buy it as is so I am not the manufacturer of it.
- Auditor: Ok, then you don’t have a validation report?
- You: No!!!
- Auditor: Ok, then this is an observation
In this episode with Christophe Girardey from WEGA we will review what is expected from you regarding the validation of such software
podcast.easymedicaldevice.com/241-2/
#medicaldevices #easymedicaldevice #regulatoryaffairs #eqms
1 year ago | [YT] | 0