Hi All..
This is regarding the design controls 21 CFR 820.30.
1. Is it necessary to have business requirements in the product requirements and specifications document?
2. We have given the priority levels to the specifications (design outputs) as high (1), medium(2) and low(3). But not defined anywhere in the trace matrix that priority 1 specs are essential specs for proper functioning of the device. Will it be a non conformance?
3. For non-essential design specs (outputs)(in this case, for moderate and low priorities), is it mandatory to have verification and/or validation activities performed to show in the trace matrix?
4. Where to keep the training records for a new product--with HR or in DHF??
Thanks,
Sreenu
This is regarding the design controls 21 CFR 820.30.
1. Is it necessary to have business requirements in the product requirements and specifications document?
2. We have given the priority levels to the specifications (design outputs) as high (1), medium(2) and low(3). But not defined anywhere in the trace matrix that priority 1 specs are essential specs for proper functioning of the device. Will it be a non conformance?
3. For non-essential design specs (outputs)(in this case, for moderate and low priorities), is it mandatory to have verification and/or validation activities performed to show in the trace matrix?
4. Where to keep the training records for a new product--with HR or in DHF??
Thanks,
Sreenu