S
ShaniQA
Hello everyone,
I'll appreciate your help- I'm trying to establish a retention policy for our quality records.
On our last surveillance audit we were told that batch records should be saved for 15 years according to the European directive. I'm trying to find the reference for this guidance; maybe someone can refer me to it?
Our product shelf life is 2 years (long term implant, class III).
I'm trying to figure out for how long I need to retain the other quality records such as:
Thank you in advance,
Shani.
I'll appreciate your help- I'm trying to establish a retention policy for our quality records.
On our last surveillance audit we were told that batch records should be saved for 15 years according to the European directive. I'm trying to find the reference for this guidance; maybe someone can refer me to it?
Our product shelf life is 2 years (long term implant, class III).
I'm trying to figure out for how long I need to retain the other quality records such as:
- Expired procedures (5 years?)
- Change orders
- CAPA forms
- Non-conformities reports
- Costumer complaints
- Internal audit records
- Management reviews
- Risk assessments
- Employees training sheets
- Process control logs – daily calibration, cleaning records, clean room
monitoring, pest control, etc.)- Change orders
- CAPA forms
- Non-conformities reports
- Costumer complaints
- Internal audit records
- Management reviews
- Risk assessments
- Employees training sheets
- Process control logs – daily calibration, cleaning records, clean room
Thank you in advance,
Shani.
